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Zhang H, Gu X, He W, Zhao SL, Cao ZJ. Epstein-Barr virus infection is an independent risk factor for surgery in patients with moderate-to-severe ulcerative colitis. World J Gastroenterol 2025; 31:104758. [PMID: 40308799 PMCID: PMC12038525 DOI: 10.3748/wjg.v31.i16.104758] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/31/2024] [Revised: 03/18/2025] [Accepted: 04/14/2025] [Indexed: 04/27/2025] Open
Abstract
BACKGROUND Epstein-Barr virus (EBV) infection of the intestinal mucosa is associated with surgical risk in ulcerative colitis (UC); however, the exact effect remains unclear. AIM To determine whether EBV infection can predict the need for colectomy and to develop a surgical risk predictive model. METHODS This was a single-center retrospective study of 153 patients with moderate-to-severe UC between September 2012 and May 2023. EBV-encoded small RNA (EBER) in situ hybridization and immunohistochemistry (IHC) were used for EBV testing and assessment. Cytomegalovirus (CMV) was detected by IHC. Logistic regression analysis was conducted to identify risk factors for colectomy and develop a predictive risk model. RESULTS EBER-positivity in the intestinal mucosa was present in 40.4% (19/47) and 4.7% (5/106) of patients in the surgery and non-surgery groups, respectively, with significant differences between the groups (P < 0.01, odds ratio = 13.707). The result of multivariate logistic regression revealed that age, EBV infection in the colonic mucosa, CMV infection in the colonic mucosa, and treatment with three or more immunosuppressive agents before admission were significant independent predictors of colectomy. A nomogram incorporating these variables demonstrated good discriminative ability, and exhibited good calibration and clinical utility. IHC showed that EBV-infected cells mainly included B and T lymphocytes in patients with high EBER concentrations. CONCLUSION EBV infection of the intestinal mucosa is a significant independent risk factor for colectomy in patients with moderate-to-severe UC. The nomogram model, which includes EBV infection, effectively predicts colectomy risk.
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Affiliation(s)
- Hui Zhang
- Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200001, China
| | - Xi Gu
- Division of Pathology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200001, China
| | - Wei He
- Division of Pathology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200001, China
| | - Shu-Liang Zhao
- Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200001, China
| | - Zhi-Jun Cao
- Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200001, China
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2
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Vinchurkar K, Togale M, Maste P, Chaudhary S, Ahmed I, Krishnamurthy S, Bhise R, Mane J, Kumbar P. Truly Inevitable-Our Perspective on the Complications After Surgery for Rectal Cancer. Indian J Surg Oncol 2025; 16:667-675. [PMID: 40337030 PMCID: PMC12052641 DOI: 10.1007/s13193-024-02125-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/03/2024] [Accepted: 10/22/2024] [Indexed: 01/04/2025] Open
Abstract
Rectal cancer is one of the most common malignancies in the GI tract. Although recent technology and treatments are available today, complications are still there. The focus of this study is to draw attention towards the important complications and their management options in rectal cancer surgeries. Retrospective study of 57 patients diagnosed and operated with rectal cancer between 2012 and 2022 using questionnaire data. 21.05% developed complications following surgery for rectal cancer including SSI, LARS, anastomosis leak, and stomal stenosis. LARS was seen in 26.31% out of the 19 patients involved in the study (LAR + ULAR) of which 80% had minor LARS scores and 20% had major LARS scores. In LARS, 80% had received long-term chemoradiotherapy in a neoadjuvant setting. The study revealed a rising trend of rectal cancer in young individuals (35.08%). Complications are an inevitable part of rectal cancer surgery even with recent technology. Use of long-course radiotherapy in neoadjuvant settings and LAR and ULAR may improve sphincter preservation with the risk of increasing incidence of low anterior resection syndrome, and anastomosis leak should be used cautiously with proper patient selection.
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Affiliation(s)
- Kumar Vinchurkar
- Department of Surgical Oncology, KAHER’s Jawaharlal Nehru Medical College, Belagavi, India
| | - Manoj Togale
- Department of General Surgery, KAHER’s Jawaharlal Nehru Medical College, Belagavi, India
| | - Preeti Maste
- Department of Microbiology, KAHER’s Jawaharlal Nehru Medical College, Belagavi, India
| | - Saurin Chaudhary
- Department of Surgical Oncology, KAHER’s Jawaharlal Nehru Medical College, Belagavi, India
| | - Imtiaz Ahmed
- Department of Radiation Oncology, KAHER’s Jawaharlal Nehru Medical College, Belagavi, India
| | - Sapna Krishnamurthy
- Department of Radiation Oncology, KAHER’s Jawaharlal Nehru Medical College, Belagavi, India
| | - Rohan Bhise
- Department of Medical Oncology, KAHER’s Jawaharlal Nehru Medical College, Belagavi, India
| | - Jyoti Mane
- KAHER’s Jawaharlal Nehru Medical College, Belagavi, India
| | - Praveen Kumbar
- KAHER’s Jawaharlal Nehru Medical College, Belagavi, India
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3
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Tweed TTT, Tummers S, Boerma EJG, Bouvy ND, van Dijk DPJ, Stoot JHMB. Minimal invasive surgery protects against severe postoperative complications regardless of body composition in patients undergoing colorectal surgery. EUROPEAN JOURNAL OF SURGICAL ONCOLOGY 2025; 51:109561. [PMID: 39754963 DOI: 10.1016/j.ejso.2024.109561] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/13/2024] [Revised: 12/06/2024] [Accepted: 12/18/2024] [Indexed: 01/06/2025]
Abstract
BACKGROUND For many colorectal cancer patients, primary surgery is the standard care of treatment. Further insights in perioperative care are crucial. The aim of this study is to assess the prognostic value of body composition for postoperative complications after laparoscopic and open colorectal surgery. METHODS From January 2013 to 2018 all consecutive patients who underwent surgery for colorectal cancer were enrolled in this study. Patients with a preoperative CT-scan <90 days before surgery were included. All CT-scans were obtained retrospectively, and body composition was analysed using a single transverse slice at the level of the third lumbar vertebra (L3) within the Slice-O-Matic-software. The studied outcome measure was the occurrence of major postoperative complications (Clavien-Dindo grade ≥3b). RESULTS A total of 1213 patients were included in the final analyses. Multivariable analyses showed that patients with low-skeletal muscle mass Z-score (OR 0.67, 95 % CI 0.45-0.97, p = 0.036) or a high visceral adipose tissue Z-score (OR 1.56, 95 % CI 1.06-2.29, p = 0.023) were significantly associated with an increased risk of developing major postoperative complications after open surgery. In the laparoscopic group, all six body composition parameters were not significantly associated with an increased risk of developing a major postoperative complication. CONCLUSIONS In this study, open colorectal surgery in patients with either low skeletal muscle mass or high visceral adipose tissue mass was associated with increased risk of postoperative complications. Laparoscopic surgery did not show this correlation. This demonstrates the importance of using minimal invasive surgery in colorectal cancer patients and implementing this as standard care.
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Affiliation(s)
| | - Stan Tummers
- Zuyderland Medical Centre Sittard/Heerlen, the Netherlands
| | | | - Nicole D Bouvy
- Maastricht University Medical Center, Maastricht, the Netherlands
| | - David P J van Dijk
- Zuyderland Medical Centre Sittard/Heerlen, the Netherlands; Maastricht University Medical Center, Maastricht, the Netherlands
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Ahmed NS, Krawchuk S, Buhler KA, Solitano V, Jairath V, Shaheen AA, Seow CH, Novak KL, Ingram RJM, Lu C, Kotze PG, Kaplan GG, Panaccione R, Ma C. US National Estimates of Contemporary Mortality Rates in Patients With Ulcerative Colitis Undergoing Colectomy. Am J Gastroenterol 2025; 120:478-481. [PMID: 39140476 DOI: 10.14309/ajg.0000000000003031] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/22/2024] [Accepted: 07/20/2024] [Indexed: 08/15/2024]
Abstract
INTRODUCTION Despite a growing armamentarium of medical therapies for ulcerative colitis, colectomy remains an important therapeutic option. To better inform shared decision-making about surgery, we estimated the contemporary risk of mortality after colectomy. METHODS Mortality rates were estimated using the National Inpatient Sample (2016-2020). Factors associated with postcolectomy death were evaluated in multivariable regression. RESULTS Postcolectomy mortality occurred in 1.2% (95% CI: 0.8%, 1.9%) of hospitalizations. Comorbidity burden, emergent laparotomy, and delays to surgery >5 days after admission were associated with mortality. DISCUSSION Colectomy may be associated with mortality; however, this risk is heterogeneous based on patient- and procedural-related factors.
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Affiliation(s)
| | - Satchel Krawchuk
- Faculty of Dentistry, University of Toronto, Toronto, Ontario, Canada
| | - Katherine A Buhler
- Inflammatory Bowel Disease Unit, Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada
| | - Virginia Solitano
- Department of Medicine, Division of Gastroenterology, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
- Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy
- Department of Gastroenterology and Endoscopy, Università Vita-Salute San Raffaele, Milan, Italy
| | - Vipul Jairath
- Department of Medicine, Division of Gastroenterology, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada
- Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada
| | - Abdel Aziz Shaheen
- Inflammatory Bowel Disease Unit, Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada
- Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - Cynthia H Seow
- Inflammatory Bowel Disease Unit, Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada
| | - Kerri L Novak
- Inflammatory Bowel Disease Unit, Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada
| | - Richard J M Ingram
- Inflammatory Bowel Disease Unit, Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada
| | - Cathy Lu
- Inflammatory Bowel Disease Unit, Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada
| | - Paulo G Kotze
- Colorectal Surgery Unit, Catholic University, Curitiba, Paraná, Brazil
| | - Gilaad G Kaplan
- Inflammatory Bowel Disease Unit, Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada
- Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - Remo Panaccione
- Inflammatory Bowel Disease Unit, Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada
| | - Christopher Ma
- Inflammatory Bowel Disease Unit, Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada
- Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
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Overstreet DS, Hollis RH. Achieving Health Equity: Advancing Colorectal Surgery among Racial and Ethnic Minorities in America. Clin Colon Rectal Surg 2025; 38:34-40. [PMID: 39734714 PMCID: PMC11679203 DOI: 10.1055/s-0044-1786532] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2024]
Abstract
Racial inequities in short and long-term outcomes following colorectal surgery continue to persist. Using inflammatory bowel disease and colorectal cancer as disease foci, we review existing racial inequities in surgical outcomes and complications, discuss how social determinants of health and biopsychosocial factors can contribute to these inequities, and highlight potential mechanisms for building interventions to achieve health equity following colorectal surgery for minority populations.
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Affiliation(s)
- Demario S. Overstreet
- Division of Gastrointestinal Surgery, Department of General Surgery, University of Alabama at Birmingham, Birmingham, Alabama
| | - Robert H. Hollis
- Division of Gastrointestinal Surgery, Department of General Surgery, University of Alabama at Birmingham, Birmingham, Alabama
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6
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Dulai PS, Bonner LB, Sadler C, Raffals LE, Kochhar G, Lindholm P, Buckey JC, Toups GN, Rosas L, Narula N, Jairath V, Honap S, Peyrin‐Biroulet L, Sands BE, Hanauer SB, Scholtens DM, Siegel CA. Clinical Trial Design Considerations for Hospitalised Patients With Ulcerative Colitis Flares and Application to Study Hyperbaric Oxygen Therapy in the NIDDK HBOT-UC Consortium. Aliment Pharmacol Ther 2024; 60:1512-1524. [PMID: 39403018 PMCID: PMC11599782 DOI: 10.1111/apt.18326] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2024] [Revised: 07/19/2024] [Accepted: 09/23/2024] [Indexed: 11/01/2024]
Abstract
BACKGROUND Patients with ulcerative colitis (UC) who are hospitalised for acute severe flares represent a high-risk orphan population. AIM To provide guidance for clinical trial design methodology in these patients. METHODS We created a multi-centre consortium to design and conduct a clinical trial for a novel therapeutic intervention (hyperbaric oxygen therapy) in patients with UC hospitalised for moderate-severe flares. During planning, we identified and addressed specific gaps for inclusion/exclusion criteria; disease activity measures; pragmatic trial design considerations within care pathways for hospitalised patients; standardisation of care delivery; primary and secondary outcomes; and sample size and statistical analysis approaches. RESULTS The Truelove-Witt criteria should not be used in isolation. Endoscopy is critical for defining eligible populations. Patient-reported outcomes should include rectal bleeding and stool frequency, with secondary measurement of urgency and nocturnal bowel movements. Trial design needs to be tailored to care pathways, with early intervention focused on replacing and/or optimising responsiveness to steroids and later interventions focused on testing novel rescue agents or strategies. The PRECIS-2 framework offers a means of tailoring to local populations. We provide standardisation of baseline testing, venous thromboprophylaxis, steroid dosing, discharge criteria and post-discharge follow-up to avoid confounding by usual care variability. Statistical considerations are provided given the small clinical trial nature of this population. CONCLUSION We provide an outline for framework decisions made for the hyperbaric oxygen trial in patients hospitalised for UC flares. Future research should focus on the remaining gaps identified.
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Affiliation(s)
- Parambir S. Dulai
- Division of Gastroenterology and HepatologyNorthwestern UniversityChicagoIllinoisUSA
| | - Lauren Balmert Bonner
- Department of Preventive Medicine, Division of BiostatisticsNorthwestern UniversityChicagoIllinoisUSA
- Northwestern University Data Analysis and Coordinating Center (NUDACC)ChicagoIllinoisUSA
| | - Charlotte Sadler
- Division of Hyperbaric Medicine, Department of Emergency MedicineUniversity of California San DiegoLa JollaCaliforniaUSA
| | - Laura E. Raffals
- Division of Gastroenterology and HepatologyMayo ClinicRochesterMinnesotaUSA
| | - Gursimran Kochhar
- Division of Gastroenterology and HepatologyAlleghany HealthPittsburghPennsylvaniaUSA
| | - Peter Lindholm
- Division of Hyperbaric Medicine, Department of Emergency MedicineUniversity of California San DiegoLa JollaCaliforniaUSA
| | - Jay C. Buckey
- Hyperbaric MedicineDartmouth Hitchcock Medical CenterLebanonNew HampshireUSA
| | | | - Libeth Rosas
- Division of Gastroenterology and HepatologyNorthwestern UniversityChicagoIllinoisUSA
| | - Neeraj Narula
- Division of Gastroenterology and Farncombe Family Digestive Health Research InstituteMcMaster UniversityHamiltonOntarioCanada
| | - Vipul Jairath
- Division of Gastroenterology, Schulich School of MedicineWestern UniversityLondonOntarioCanada
- Lawson Health Research InstituteWestern UniversityLondonOntarioCanada
- Department of Epidemiology and BiostatisticsWestern UniversityLondonOntarioCanada
| | - Sailish Honap
- School of Immunology and Microbial SciencesKing's College LondonUK
- INFINY InstituteNancy University HospitalVandœuvre‐lès‐NancyFrance
| | | | - Bruce E. Sands
- Dr. Henry D. Janowitz Division of GastroenterologyIcahn School of Medicine at Mount SinaiNew YorkNew YorkUSA
| | - Stephen B. Hanauer
- Division of Gastroenterology and HepatologyNorthwestern UniversityChicagoIllinoisUSA
| | - Denise M. Scholtens
- Department of Preventive Medicine, Division of BiostatisticsNorthwestern UniversityChicagoIllinoisUSA
- Northwestern University Data Analysis and Coordinating Center (NUDACC)ChicagoIllinoisUSA
| | - Corey A. Siegel
- Division of Gastroenterology and HepatologyDartmouth Hitchcock Medical CenterLebanonNew HampshireUSA
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7
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Schultz KS, Moore MS, Pantel HJ, Mongiu AK, Reddy VB, Schneider EB, Leeds IL. For whom the bell tolls: assessing the incremental costs associated with failure to rescue after elective colorectal surgery. J Gastrointest Surg 2024; 28:1812-1818. [PMID: 39181234 DOI: 10.1016/j.gassur.2024.08.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/12/2024] [Revised: 08/07/2024] [Accepted: 08/18/2024] [Indexed: 08/27/2024]
Abstract
BACKGROUND Failure to rescue after elective surgery is associated with increased healthcare costs. These costs are poorly understood and have not been reported for colorectal surgery. This study aimed to assess the incremental costs of failure to rescue after elective colorectal surgery. METHODS This was a retrospective study of adult patients identified in the National Inpatient Sample from 2016 to 2019 who underwent an elective colectomy or proctectomy. Patients were stratified into 4 groups: uneventful recovery, successfully rescued, failure to rescue, and died without rescue attempts. "Rescue" was defined as admissions with ≥1 procedure code ≥1 day after the initial procedure. The primary outcome was total admission costs. RESULTS Of 451,490 admissions for elective colorectal resection, 94.6% had an uneventful recovery, 4.8% were successfully rescued, 0.4% were failure to rescue, and 0.3% died without rescue attempts. The median total hospital cost for the uneventful recovery cohort was $16,751 (IQR, $12,611-$23,116), for the successfully rescued cohort was $42,295 (IQR, $27,959-$67,077), for the failure-to-rescue cohort was $53,182 (IQR, $30,852-$95,615), and for the died without attempted rescue cohort was $29,296 (IQR, $19,812-$45,919). When comparing cost quantiles by regression analysis, failure-to-rescue patients had significantly higher costs than the successfully rescued patients for the last 3 quantiles (fifth quantile [90th percentile], $163,963 vs $106,521; P < .001). CONCLUSION Across a nationally representative cohort, the median total hospital costs for patients who failed to be rescued were $10,887 more than for those who were successfully rescued. These findings emphasize the importance of shared decision making and medical futility and highlight opportunities for resource optimization after postoperative complications.
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Affiliation(s)
- Kurt S Schultz
- Division of Colon and Rectal Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT, United States
| | - Miranda S Moore
- Division of Colon and Rectal Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT, United States
| | - Haddon J Pantel
- Division of Colon and Rectal Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT, United States
| | - Anne K Mongiu
- Division of Colon and Rectal Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT, United States
| | - Vikram B Reddy
- Division of Colon and Rectal Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT, United States
| | - Eric B Schneider
- Division of Colon and Rectal Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT, United States
| | - Ira L Leeds
- Division of Colon and Rectal Surgery, Department of Surgery, Yale School of Medicine, New Haven, CT, United States.
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Giddings HL, Ng KS, Solomon MJ, Steffens D, Van Buskirk J, Young J. Unexpected variation in outcomes following total (procto)colectomies for ulcerative colitis in New South Wales, Australia: a population-based 19-year linked-data study. Colorectal Dis 2024; 26:1584-1596. [PMID: 38937922 DOI: 10.1111/codi.17074] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/28/2023] [Revised: 02/02/2024] [Accepted: 01/06/2024] [Indexed: 06/29/2024]
Abstract
AIM Total (procto)colectomy for ulcerative colitis (UC) is associated with significant morbidity, which is increased in the emergency setting. This study aimed to evaluate the outcomes following total (procto)colectomies at a population level within New South Wales (NSW), Australia, and identify case mix and hospital factors associated with these outcomes. METHODS A retrospective data linkage study of patients undergoing total (procto)colectomy for UC in NSW over a 19-year period (2001-2020) was performed. The primary outcome was 90-day mortality. The influence of hospital level factors (including annual volume) and patient demographic variables on outcomes was assessed using logistic regression. Temporal trends in annual volume and evidence for centralization were assessed. RESULTS In all, 1418 patients (mean 47.0 years [SD 18.7], 58.7% male) underwent total (procto)colectomy during the study period. The overall 90-day mortality rate was 3.2% (emergency 8.6% and elective 0.8%). After adjusting for confounding, increasing age at total (procto)colectomy, higher comorbidity burden, public health insurance (Medicare) status, emergency operation and living outside a major city were significantly associated with increased mortality. Hospital volume was significantly associated with mortality at a univariate level, but this did not persist on multivariate modelling. CONCLUSIONS Outcomes of UC patients undergoing total (procto)colectomy in NSW Australia are comparable to international experience. Whilst higher mortality rates are observed in low volume and public hospitals, this appears attributable to case mix and acuity rather than surgical volume alone. However, as inflammatory bowel disease surgery is not centralized in Australia, only one NSW hospital performed >10 UC total (procto)colectomies annually. Variation in mortality according to insurance status and across regional/remote areas may indicate inequality in the availability of specialist inflammatory bowel disease treatment, which warrants further research.
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Affiliation(s)
- Hugh L Giddings
- Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Surgical Outcomes Research Centre (SouRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Institute of Academic Surgery (IAS), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
| | - Kheng-Seong Ng
- Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Surgical Outcomes Research Centre (SouRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Faculty of Medicine and Health, Central Clinical School, University of Sydney, Sydney, New South Wales, Australia
| | - Michael J Solomon
- Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Surgical Outcomes Research Centre (SouRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Institute of Academic Surgery (IAS), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Faculty of Medicine and Health, Central Clinical School, University of Sydney, Sydney, New South Wales, Australia
| | - Daniel Steffens
- Surgical Outcomes Research Centre (SouRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Faculty of Medicine and Health, Central Clinical School, University of Sydney, Sydney, New South Wales, Australia
| | - Joe Van Buskirk
- Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia
- Public Health Research Analytics and Methods for Evidence, Sydney, New South Wales, Australia
| | - Jane Young
- Surgical Outcomes Research Centre (SouRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
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9
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Lelièvre O, Benoist S, Brouquet A. Indications, modalities, and outcomes of surgery for ulcerative colitis in 2024. J Visc Surg 2024; 161:182-193. [PMID: 38897710 DOI: 10.1016/j.jviscsurg.2024.05.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/21/2024]
Abstract
Treatment of ulcerative colitis (UC) has been revolutionized by the arrival of biotherapies and technical progress in interventional endoscopy and surgery. (Sub)total emergency colectomy is required in the event of complicated severe acute colitis: colectasis, perforation, hemorrhage, organ failure. Corticosteroid therapy is the reference treatment for uncomplicated severe acute colitis, while infliximab and ciclosporin are 2nd-line treatments. At each step, before and after each line of treatment failure, surgery should be considered as an option. In cases refractory to medical treatment, the choice between surgery and change in medication must weigh the chronic symptoms associated with the disease against the risks of postoperative complications and functional sequelae inherent to surgery. Detection of dysplastic lesions necessitates chromoendoscopic imaging with multiple biopsies and anatomopathological verification. Endoscopic treatment of these lesions remains reserved for selected patients. These different indications call for multidisciplinary medical-surgical discussion. Total coloproctectomy with ileo-anal anastomosis (TCP-IAA) is the standard surgery, and it holds out hope for healing. Modalities depend on patient characteristics, previous emergency colectomy, and presence of dysplasia. It may be carried out in one, in two modified, or in three phases. The main complications are anastomotic fistula, short-term pouch-related fistula, ileo-anal pouch syndrome, pouchitis and long-term digestive and sexual disorders. For selected cases, an alternative can consist in total colectomy with ileo-rectal anastomosis or permanent terminal ileostomy. The objective of this update is to clarify the indications, modalities, and results of surgical treatment of ulcerative colitis in accordance with the most recent data in the literature.
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Affiliation(s)
- Océane Lelièvre
- Department of oncologic and digestive surgery, Bicêtre Hospital, Assistance publique-Hôpitaux de Paris, Le Kremlin-Bicêtre, France; Paris-Saclay University, Paris, France
| | - Stéphane Benoist
- Department of oncologic and digestive surgery, Bicêtre Hospital, Assistance publique-Hôpitaux de Paris, Le Kremlin-Bicêtre, France; Paris-Saclay University, Paris, France
| | - Antoine Brouquet
- Department of oncologic and digestive surgery, Bicêtre Hospital, Assistance publique-Hôpitaux de Paris, Le Kremlin-Bicêtre, France; Paris-Saclay University, Paris, France.
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10
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Ullrich SJ, Frischer JS. Surgical management of complicated Crohn's disease. Semin Pediatr Surg 2024; 33:151399. [PMID: 38642531 DOI: 10.1016/j.sempedsurg.2024.151399] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/22/2024]
Abstract
Surgical management of pediatric Crohn's disease is fundamentally palliative, aiming to treat the sequalae of complicated disease while preserving intestinal length. Multidisciplinary discussion of risk factors and quality of life should take place prior to operative intervention. Though the surgical management of pediatric Crohn's disease is largely based on the adult literature, there are considerations specific to the pediatric population - notably disease and treatment effects on growth and development. Intrabdominal abscess is approached with percutaneous drainage when feasible, reserving surgical intervention for the patient who is unstable or failing medical therapy. Pediatric patients with fibrostenotic disease should be considered for strictureplasty when possible, for maximum preservation of bowel length. Patients with medically refractory Crohn's proctocolitis should be treated initially with fecal diversion without proctocolectomy.
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Affiliation(s)
- Sarah J Ullrich
- Colorectal Center at Cincinnati Children's Hospital, Divison of Pediatric General & Thoracic Surgery, 3333 Burnet Ave, MLC-2024, Cincinnati, OH 45229, USA
| | - Jason S Frischer
- Colorectal Center at Cincinnati Children's Hospital, Divison of Pediatric General & Thoracic Surgery, 3333 Burnet Ave, MLC-2024, Cincinnati, OH 45229, USA.
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11
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Syversen A, Dosis A, Jayne D, Zhang Z. Wearable Sensors as a Preoperative Assessment Tool: A Review. SENSORS (BASEL, SWITZERLAND) 2024; 24:482. [PMID: 38257579 PMCID: PMC10820534 DOI: 10.3390/s24020482] [Citation(s) in RCA: 10] [Impact Index Per Article: 10.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/23/2023] [Revised: 01/06/2024] [Accepted: 01/09/2024] [Indexed: 01/24/2024]
Abstract
Surgery is a common first-line treatment for many types of disease, including cancer. Mortality rates after general elective surgery have seen significant decreases whilst postoperative complications remain a frequent occurrence. Preoperative assessment tools are used to support patient risk stratification but do not always provide a precise and accessible assessment. Wearable sensors (WS) provide an accessible alternative that offers continuous monitoring in a non-clinical setting. They have shown consistent uptake across the perioperative period but there has been no review of WS as a preoperative assessment tool. This paper reviews the developments in WS research that have application to the preoperative period. Accelerometers were consistently employed as sensors in research and were frequently combined with photoplethysmography or electrocardiography sensors. Pre-processing methods were discussed and missing data was a common theme; this was dealt with in several ways, commonly by employing an extraction threshold or using imputation techniques. Research rarely processed raw data; commercial devices that employ internal proprietary algorithms with pre-calculated heart rate and step count were most commonly employed limiting further feature extraction. A range of machine learning models were used to predict outcomes including support vector machines, random forests and regression models. No individual model clearly outperformed others. Deep learning proved successful for predicting exercise testing outcomes but only within large sample-size studies. This review outlines the challenges of WS and provides recommendations for future research to develop WS as a viable preoperative assessment tool.
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Affiliation(s)
- Aron Syversen
- School of Computing, University of Leeds, Leeds LS2 9JT, UK
| | - Alexios Dosis
- School of Medicine, University of Leeds, Leeds LS2 9JT, UK; (A.D.); (D.J.)
| | - David Jayne
- School of Medicine, University of Leeds, Leeds LS2 9JT, UK; (A.D.); (D.J.)
| | - Zhiqiang Zhang
- School of Electrical Engineering, University of Leeds, Leeds LS2 9JT, UK;
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12
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Giddings HL, Ng KS, Solomon MJ, Steffens D, Van Buskirk J, Young J. Reducing rate of total colectomies for ulcerative colitis but higher morbidity in the biologic era: an 18-year linked data study from New South Wales Australia. ANZ J Surg 2023; 93:2928-2938. [PMID: 37795917 DOI: 10.1111/ans.18713] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2023] [Revised: 09/06/2023] [Accepted: 09/19/2023] [Indexed: 10/06/2023]
Abstract
BACKGROUND This study aims to investigate the trends in UC surgery in New South Wales (NSW) at a population level. METHODS A retrospective data linkage study of the NSW population was performed. Patients of any age with a diagnosis of UC who underwent a total abdominal colectomy (TAC) ± proctectomy between Jul-2001 and Jun-2019 were included. The age adjusted population rate was calculated using Australian Bureau of Statistics data. Multivariable linear regression modelled the trend of TAC rates, and assessed the effect of infliximab (listed on the Pharmaceutical Benefits Scheme for UC in Apr-2014). RESULTS A total of 1365 patients underwent a TAC ± proctectomy (mean age 47.0 years (±18.6), 59% Male). Controlling for differences between age groups, the annual rate of UC TACs decreased by 2.4% each year (95% CI 1.4%-3.4%) over the 18-year period from 1.30/100000 (2002) to 0.84/100000 (2019). An additional incremental decrease in the rate of TACs was observed after 2014 (OR 0.83, 95% CI 0.69-1.00). There was no change in the proportion of TACs performed emergently over the study period (OR 1.02, 95% CI 0.998-1.04). The odds of experiencing any perioperative surgical complication (aOR 1.54, 95% CI 1.01-2.33, P = 0.043), and requiring ICU admission (aOR 1.85, 95% CI 1.24-2.76, P = 0.003) significantly increased in 2014-2019 compared to 2002-2007. CONCLUSIONS The rate of TACs for UC has declined over the past two decades. This rate decrease may have been further influenced by the introduction of biologics. Higher rates of complications and ICU admissions in the biologic era may indicate poorer patient physiological status at the time of surgery.
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Affiliation(s)
- Hugh L Giddings
- Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Institute of Academic Surgery (IAS), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
| | - Kheng-Seong Ng
- Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, New South Wales, Australia
| | - Michael J Solomon
- Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Institute of Academic Surgery (IAS), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, New South Wales, Australia
| | - Daniel Steffens
- Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
- Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, New South Wales, Australia
| | - Joe Van Buskirk
- Faculty of Medicine and Health, Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia
- Public Health Research Analytics and Methods for Evidence, Sydney Local Health District, Sydney, New South Wales, Australia
| | - Jane Young
- Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
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13
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Kabir M, Thomas-Gibson S, Tozer PJ, Warusavitarne J, Faiz O, Hart A, Allison L, Acheson AG, Atici SD, Avery P, Brar M, Carvello M, Choy MC, Dart RJ, Davies J, Dhar A, Din S, Hayee B, Kandiah K, Katsanos KH, Lamb CA, Limdi JK, Lovegrove RE, Myrelid P, Noor N, Papaconstantinou I, Petrova D, Pavlidis P, Pinkney T, Proud D, Radford S, Rao R, Sebastian S, Segal JP, Selinger C, Spinelli A, Thomas K, Wolthuis A, Wilson A. DECIDE: Delphi Expert Consensus Statement on Inflammatory Bowel Disease Dysplasia Shared Management Decision-Making. J Crohns Colitis 2023; 17:1652-1671. [PMID: 37171140 DOI: 10.1093/ecco-jcc/jjad083] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/21/2023] [Indexed: 05/13/2023]
Abstract
BACKGROUND AND AIMS Inflammatory bowel disease colitis-associated dysplasia is managed with either enhanced surveillance and endoscopic resection or prophylactic surgery. The rate of progression to cancer after a dysplasia diagnosis remains uncertain in many cases and patients have high thresholds for accepting proctocolectomy. Individualised discussion of management options is encouraged to take place between patients and their multidisciplinary teams for best outcomes. We aimed to develop a toolkit to support a structured, multidisciplinary and shared decision-making approach to discussions about dysplasia management options between clinicians and their patients. METHODS Evidence from systematic literature reviews, mixed-methods studies conducted with key stakeholders, and decision-making expert recommendations were consolidated to draft consensus statements by the DECIDE steering group. These were then subjected to an international, multidisciplinary modified electronic Delphi process until an a priori threshold of 80% agreement was achieved to establish consensus for each statement. RESULTS In all, 31 members [15 gastroenterologists, 14 colorectal surgeons and two nurse specialists] from nine countries formed the Delphi panel. We present the 18 consensus statements generated after two iterative rounds of anonymous voting. CONCLUSIONS By consolidating evidence for best practice using literature review and key stakeholder and decision-making expert consultation, we have developed international consensus recommendations to support health care professionals counselling patients on the management of high cancer risk colitis-associated dysplasia. The final toolkit includes clinician and patient decision aids to facilitate shared decision-making.
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Affiliation(s)
- Misha Kabir
- Division of GI Services, University College London Hospitals NHS Foundation Trust, London, UK
- Department of Surgery and Cancer or Department of Metabolism, Digestion and Reproduction, Imperial College London , London, UK
| | - Siwan Thomas-Gibson
- Department of Surgery and Cancer or Department of Metabolism, Digestion and Reproduction, Imperial College London , London, UK
- Department of Gastroenterology or Department of Colorectal Surgery, St Mark's Hospital, London, UK
| | - Phil J Tozer
- Department of Surgery and Cancer or Department of Metabolism, Digestion and Reproduction, Imperial College London , London, UK
- Department of Gastroenterology or Department of Colorectal Surgery, St Mark's Hospital, London, UK
| | - Janindra Warusavitarne
- Department of Surgery and Cancer or Department of Metabolism, Digestion and Reproduction, Imperial College London , London, UK
- Department of Gastroenterology or Department of Colorectal Surgery, St Mark's Hospital, London, UK
| | - Omar Faiz
- Department of Surgery and Cancer or Department of Metabolism, Digestion and Reproduction, Imperial College London , London, UK
- Department of Gastroenterology or Department of Colorectal Surgery, St Mark's Hospital, London, UK
| | - Ailsa Hart
- Department of Surgery and Cancer or Department of Metabolism, Digestion and Reproduction, Imperial College London , London, UK
- Department of Gastroenterology or Department of Colorectal Surgery, St Mark's Hospital, London, UK
| | - Lisa Allison
- Department of Gastroenterology, Royal Free Hospital, London, UK
| | - Austin G Acheson
- Department of Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK
| | - Semra Demirli Atici
- Department of Surgery, University of Health Sciences Tepecik Training and Research Hospital, Izmir, Turkey
| | - Pearl Avery
- Department of Gastroenterology or Department of Colorectal Surgery, St Mark's Hospital, London, UK
| | - Mantaj Brar
- Department of Surgery, Mount Sinai Hospital, University of Toronto, Toronto, Canada
| | - Michele Carvello
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Department of Surgery, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Matthew C Choy
- Department of Gastroenterology, Austin Health, Melbourne, VIC, Australia
- Division of Medicine, Dentistry and Health Sciences, University of Melbourne, Austin Academic Centre, Melbourne, VIC, Australia
| | - Robin J Dart
- Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK
| | - Justin Davies
- Department of Gastroenterology, Addenbrooke's Hospital, Cambridge, UK
- Department of Medicine, University of Cambridge, Cambridge, UK
| | - Anjan Dhar
- Department of Gastroenterology, Darlington Memorial Hospital, County Durham & Darlington NHS Foundation Trust, Darlington, UK
- Department of Gastroenterology, Teesside University, UK, Middlesbrough, UK
| | - Shahida Din
- Edinburgh IBD Unit, NHS Lothian, Western General Hospital, Edinburgh, UK
| | - Bu'Hussain Hayee
- Department of Gastroenterology, King's College Hospital, London, UK
| | - Kesavan Kandiah
- Department of Gastroenterology, St. George's University Hospitals NHS Foundation Trust, London, UK
| | - Konstantinos H Katsanos
- Division of Gastroenterology, Department of Internal Medicine, University of Ioannina School of Health Sciences, Ioannina, Greece
| | - Christopher Andrew Lamb
- Translational & Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK
- Department of Gastroenterology, Royal Victoria Infirmary, Newcastle upon Tyne, Newcastle upon Tyne, UK
| | - Jimmy K Limdi
- Department of Gastroenterology, Northern Care Alliance NHS Foundation Trust, Greater Manchester, UK
- Department of Gastroenterology, University of Manchester , Manchester, UK
| | - Richard E Lovegrove
- Department of Surgery, Worcestershire Acute Hospitals NHS Trust , Worcester, UK
| | - Pär Myrelid
- Department of Surgery, Linköping University Hospital, Linköping, Sweden
- Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
| | - Nurulamin Noor
- Department of Gastroenterology, Cambridge University Hospitals, Addenbrooke's Hospital, Cambridge, UK
| | - Ioannis Papaconstantinou
- Department of Surgery, Aretaieion Hospital, National and Kapodistrian University of Athens, A thens, Greece
| | - Dafina Petrova
- Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain
- Escuela Andaluza de Salud Pública [EASP], Granada, Spain
- CIBER of Epidemiology and Public Health [CIBERESP], Madrid, Spain
| | - Polychronis Pavlidis
- Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust, London, UK
- Faculty of Life Sciences and Medicine, King's College London, London, UK
| | - Thomas Pinkney
- Department of Surgery, University Hospitals Birmingham, Birmingham, UK
| | - David Proud
- Department of Surgery, Austin Health, Heidelberg Victoria, VIC, Australia
| | - Shellie Radford
- Department of Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK
| | - Rohit Rao
- Department of Gastroenterology, Royal London Hospital, Barts Health NHS Trust, London, UK
| | - Shaji Sebastian
- Department of Gastroenterology, Hull University Teaching Hospitals NHS Trust, Hull, UK
| | - Jonathan P Segal
- Department of Gastroenterology, Northern Hospital Epping, University of Melbourne, Melbourne, VIC, Australia
| | - Christian Selinger
- Department of Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Antonino Spinelli
- Faculty of Life Sciences and Medicine, King's College London, London, UK
- Department of Surgery, University Hospitals Birmingham, Birmingham, UK
| | - Kathryn Thomas
- Department of Surgery, Nottingham University Hospitals, UK
| | - Albert Wolthuis
- Department of Surgery, University Hospital Leuven, The Netherlands
| | - Ana Wilson
- Department of Surgery and Cancer or Department of Metabolism, Digestion and Reproduction, Imperial College London , London, UK
- Department of Gastroenterology or Department of Colorectal Surgery, St Mark's Hospital, London, UK
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14
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Sobrado LF, Mori FNC, Facanali CBG, Camargo MGM, Nahas SC, Sobrado CW. RISK FACTORS FOR EARLY POSTOPERATIVE COMPLICATIONS IN ACUTE COLITIS IN THE ERA OF BIOLOGIC THERAPY. ARQUIVOS BRASILEIROS DE CIRURGIA DIGESTIVA : ABCD = BRAZILIAN ARCHIVES OF DIGESTIVE SURGERY 2023; 36:e1770. [PMID: 37878974 PMCID: PMC10595074 DOI: 10.1590/0102-672020230052e1770] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/22/2023] [Accepted: 04/30/2023] [Indexed: 10/27/2023]
Abstract
BACKGROUND Despite major advances in the clinical treatment of inflammatory bowel disease, some patients still present with acute colitis and require emergency surgery. AIMS To evaluate the risk factors for early postoperative complications in patients undergoing surgery for acute colitis in the era of biologic therapy. METHODS Patients with inflammatory bowel disease admitted for acute colitis who underwent total colectomy at a single tertiary hospital from 2012 to 2022 were evaluated. Postoperative complications were graded according to Clavien-Dindo classification (CDC). Patients with more severe complications (CDC≥2) were compared with those with less severe complications (CDC<2). RESULTS A total of 46 patients underwent surgery. The indications were: failure of clinical treatment (n=34), patients' or surgeon's preference (n=5), hemorrhage (n=3), toxic megacolon (n=2), and bowel perforation (n=2). There were eight reoperations, 60.9% of postoperative complications classified as CDC≥2, and three deaths. In univariate analyses, preoperative antibiotics use, ulcerative colitis diagnosis, lower albumin levels at admission, and preoperative hospital stay longer than seven days were associated with more severe postoperative complications. CONCLUSIONS Emergency surgery for acute colitis was associated with a high incidence of postoperative complications. Preoperative use of antibiotics, ulcerative colitis, lower albumin levels at admission, and delaying surgery for more than seven days were associated with more severe early postoperative complications. The use of biologics was not associated with worse outcomes.
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Affiliation(s)
- Lucas Faraco Sobrado
- Universidade de São Paulo, Coloproctology Division, Gastroenterology Department, Faculty of Medicine – São Paulo (SP), Brazil
| | - Fernando Noboru Cabral Mori
- Universidade de São Paulo, Coloproctology Division, Gastroenterology Department, Faculty of Medicine – São Paulo (SP), Brazil
| | | | - Mariane Gouvea Monteiro Camargo
- Universidade de São Paulo, Coloproctology Division, Gastroenterology Department, Faculty of Medicine – São Paulo (SP), Brazil
| | - Sérgio Carlos Nahas
- Universidade de São Paulo, Coloproctology Division, Gastroenterology Department, Faculty of Medicine – São Paulo (SP), Brazil
| | - Carlos Walter Sobrado
- Universidade de São Paulo, Coloproctology Division, Gastroenterology Department, Faculty of Medicine – São Paulo (SP), Brazil
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15
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Dudun AA, Chesnokova DV, Voinova VV, Bonartsev AP, Bonartseva GA. Changes in the Gut Microbiota Composition during Implantation of Composite Scaffolds Based on Poly(3-hydroxybutyrate) and Alginate on the Large-Intestine Wall. Polymers (Basel) 2023; 15:3649. [PMID: 37688275 PMCID: PMC10489921 DOI: 10.3390/polym15173649] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2023] [Revised: 08/23/2023] [Accepted: 08/29/2023] [Indexed: 09/10/2023] Open
Abstract
The development of biopolymer scaffolds for intestine regeneration is one of the most actively developing areas in tissue engineering. However, intestinal regenerative processes after scaffold implantation depend on the activity of the intestinal microbial community that is in close symbiosis with intestinal epithelial cells. In this work, we study the impact of different scaffolds based on biocompatible poly(3-hydroxybutyrate) (PHB) and alginate (ALG) as well as PHB/ALG scaffolds seeded with probiotic bacteria on the composition of gut microbiota of Wistar rats. Implantation of PHB/ALG scaffolds on the large-intestine wall to close its injury showed that alpha diversity of the gut microbiota was not reduced in rats implanted with different PHB/ALG scaffolds except for the PHB/ALG scaffolds with the inclusion of Lactobacillus spheres (PHB/ALG-L). The composition of the gut microbiota of rats implanted with PHB/ALG scaffolds with probiotic bacteria or in simultaneous use of an antimicrobial agent (PHB/ALG-AB) differed significantly from other experimental groups. All rats with implanted scaffolds demonstrated shifts in the composition of the gut microbiota by individual operational taxonomic units. The PHB/ALG-AB construct led to increased abundance of butyrate-producing bacteria: Ileibacterium sp. dominated in rats with implanted PHB/ALG-L and Lactobacillus sp. and Bifidobacterium sp. dominated in the control group. In addition, the PHB/ALG scaffolds had a favourable effect on the growth of commensal bacteria. Thus, the effect of implantation of the PHB/ALG scaffold compared to other scaffolds on the composition of the gut microbiota was closest to the control variant, which may demonstrate the biocompatibility of this device with the microbiota.
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Affiliation(s)
- Andrei A. Dudun
- A.N. Bach Institute of Biochemistry, Research Center of Biotechnology of the Russian Academy of Sciences, Leninsky Ave. 33, Bld. 2, 119071 Moscow, Russia;
| | - Dariana V. Chesnokova
- Faculty of Biology, M.V. Lomonosov Moscow State University, Leninskie Gory 1-12, 119234 Moscow, Russia; (D.V.C.); (V.V.V.); (A.P.B.)
| | - Vera V. Voinova
- Faculty of Biology, M.V. Lomonosov Moscow State University, Leninskie Gory 1-12, 119234 Moscow, Russia; (D.V.C.); (V.V.V.); (A.P.B.)
| | - Anton P. Bonartsev
- Faculty of Biology, M.V. Lomonosov Moscow State University, Leninskie Gory 1-12, 119234 Moscow, Russia; (D.V.C.); (V.V.V.); (A.P.B.)
| | - Garina A. Bonartseva
- A.N. Bach Institute of Biochemistry, Research Center of Biotechnology of the Russian Academy of Sciences, Leninsky Ave. 33, Bld. 2, 119071 Moscow, Russia;
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16
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Rozich JJ, Zhao B, Luo J, Luo WY, Eisenstein S, Singh S. Conventional Frailty Index Does Not Predict Risk of Postoperative Complications in Patients With IBD: A Multicenter Cohort Study. Dis Colon Rectum 2023; 66:1085-1094. [PMID: 36622750 DOI: 10.1097/dcr.0000000000002524] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
Abstract
BACKGROUND Frailty has been associated with adverse outcomes in patients with IBD. OBJECTIVE This study aimed to evaluate the association between health deficit-defined frailty (using the 5-factor modified frailty index) and postoperative outcomes in patients with IBD. DESIGN Prospective cohort study. SETTING American College of Surgeons National Surgical Quality Improvement Program, Inflammatory Bowel Diseases Module. PATIENTS The included patients had IBD and underwent major abdominal surgery between 2016 and 2019. Patients were classified as frail (modified frailty index ≥2), prefrail (modified frailty index = 1), or normal (modified frailty index = 0) based on a validated, 5-factor modified frailty index. MAIN OUTCOME MEASURES The association was evaluated between frailty and risk of 30-day severe postoperative complications, prolonged hospital stay, and risk of readmission using multivariable logistic regression. RESULTS Of 3172 patients with IBD who underwent major abdominal surgery (42.7 ± 16.4 y, 49.3% female, 57.7% with Crohn's disease, 43.9% on biologics), 116 (3.7%) were classified as frail and 477 as prefrail (15%). After adjustment for age, sex, race/ethnicity, smoking, BMI, type of surgery, corticosteroid use, and biologic and immunomodulator use, frailty was not associated with increased risk for severe postoperative complications (adjusted OR, 1.24; 95% CI, 0.81-1.90), mortality (adjusted OR, 1.38 [0.44-3.6]), or 30-day readmission (adjusted OR, 1.35 [0.77-2.30]). Nonelective surgery, significant weight loss, corticosteroid use, and need for ileostomy were associated with increased risk of severe postoperative complications. LIMITATIONS Limited information regarding IBD-specific characteristics. CONCLUSIONS In patients with IBD undergoing major abdominal surgery, frailty measured by a conventional abbreviated health deficits index is not predictive of adverse postoperative outcomes. Biologic and functional measures of frailty may better risk-stratify surgical candidacy in patients with IBDs. See Video Abstract at http://links.lww.com/DCR/C108 . EL NDICE DE FRAGILIDAD CONVENCIONAL NO PREDICE EL RIESGO DE COMPLICACIONES POSOPERATORIAS EN PACIENTES CON ENFERMEDADES INFLAMATORIAS DEL INTESTINO UN ESTUDIO DE COHORTE MULTICNTRICO ANTECEDENTES:La fragilidad se ha asociado con resultados adversos en pacientes con enfermedades inflamatorias del intestino.OBJETIVO:Examinamos la asociación entre la fragilidad definida por déficit de salud (utilizando el índice de fragilidad modificado de 5 factores) y los resultados postoperatorios en pacientes con enfermedades inflamatorias del intestino.DISEÑO:Estudio de cohorte prospective.ESCENARIO:Programa Nacional de Mejoramiento de la Calidad Quirúrgica del Colegio Estadounidense de Cirujanos, Módulo de Enfermedades Inflamatorias del Intestino.PACIENTES:Pacientes con enfermedades inflamatorias intestinales inscritos en la cohorte que se sometieron a cirugía abdominal mayor entre 2016-19.EXPOSICIÓN:Los pacientes se clasificaron como frágiles (índice de fragilidad modificado ≥2), prefrágiles (índice de fragilidad modificado = 1) o normales (índice de fragilidad modificado = 0) según un índice de fragilidad modificado de 5 factores validado.PRINCIPALES MEDIDAS DE RESULTADO:Examinamos la asociación entre la fragilidad y el riesgo de complicaciones postoperatorias graves a los 30 días, la estancia hospitalaria prolongada y el riesgo de reingreso, mediante regresión logística multivariable.RESULTADOS:De 3172 pacientes con enfermedades inflamatorias intestinales que se sometieron a cirugía abdominal mayor (42,7 ± 16,4 años, 49,3% mujeres, 57,7% con enfermedad de Crohn, 43,9% con biológicos), 116 (3,7%) fueron clasificados como frágiles y 477 como pre- frágil (15%). Después de ajustar por edad, sexo, raza/origen étnico, tabaquismo, índice de masa corporal, tipo de cirugía, uso de corticosteroides, uso de biológicos e inmunomoduladores, la fragilidad no se asoció con un mayor riesgo de complicaciones postoperatorias graves (odds ratio ajustado, 1,24; 95 % de confianza intervalos, 0,81-1,90), mortalidad (odds ratio ajustado, 1,38 [0,44-3,6]) o reingreso a los 30 días (odds ratio ajustado, 1,35 [0,77-2,30]). La cirugía no electiva, la pérdida de peso significativa, el uso de corticosteroides y la necesidad de ileostomía se asociaron con un mayor riesgo de complicaciones posoperatorias graves.LIMITACIONES:Información limitada sobre las características específicas de la enfermedad inflamatoria intestinal.CONCLUSIONES:En pacientes con enfermedades inflamatorias del intestino sometidos a cirugía abdominal mayor, la fragilidad medida por un índice de déficit de salud abreviado convencional no es predictivo de resultados postoperatorios adversos. Las medidas biológicas y funcionales de fragilidad pueden estratificar mejor la candidatura quirúrgica en pacientes con enfermedades inflamatorias del intestino. Consulte el Video Resumen en http://links.lww.com/DCR/C108 . (Traducción-Yesenia Rojas-Khalil ).
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Affiliation(s)
- Jacob J Rozich
- Department of Internal Medicine, University of California, San Diego, La Jolla, California
| | - Beiqun Zhao
- Division of Colon and Rectal Surgery, Department of Surgery, University of California, San Diego, La Jolla, California
| | - Jiyu Luo
- Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California
| | - William Y Luo
- Department of Surgery, University of North Carolina, Chapel Hill, North Carolina
| | - Samuel Eisenstein
- Division of Colon and Rectal Surgery, Department of Surgery, University of California, San Diego, La Jolla, California
| | - Siddharth Singh
- Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, California
- Division of Biomedical Informatics, Department of Medicine, University of California, San Diego, La Jolla, California
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Kawata S, Takamatsu J, Yasue Y, Fukuhara A, Kang J. Cytomegalovirus enteritis resistant to antiviral drugs improved following total colectomy. Surg Case Rep 2023; 9:109. [PMID: 37318698 DOI: 10.1186/s40792-023-01672-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2023] [Accepted: 05/15/2023] [Indexed: 06/16/2023] Open
Abstract
BACKGROUND Cytomegalovirus (CMV) infection, often subclinical in childhood, is reactivated during a state of cell-mediated immunodeficiency. In cases of organ damage, patients can require medical treatment for an infectious disease, generally through the use of antiviral drugs. There are no reports of surgical treatment in cases, where infection was found, and medical treatment was difficult. We encountered a case of CMV enteritis that was difficult to treat because of resistance to antivirals but improved after total colectomy. CASE PRESENTATION A previously healthy, 74-year-old woman visited a doctor with a chief complaint of watery diarrhea persisting for 2 weeks; she was transferred to our hospital because of hypoxemia and hypovolemic shock. Computed tomography scan indicated wall thickening over the entire colon and the patient was diagnosed with infectious colitis. Conservative and antibacterial therapies were started with fasting fluid replacement. Subsequently, bloody stools were observed 11 days after admission. Colonoscopy was then performed, which showed mucosal edema and longitudinal ulcer, while a histopathological examination of the colon mucosa revealed C7HRP positive on 22 days after admission. CMV enteritis was diagnosed, and the antiviral medication, ganciclovir, was started. Diseases causing immunosuppression and other possible causes of enteritis were also closely examined; however, all were negative. Furthermore, the patient's symptoms and her endoscopic findings did not improve with ganciclovir administration; therefore, the antiviral drug was changed to foscarnet. Unfortunately, the patient did not improve despite the additional administration of gamma globulin and methylprednisolone, and she was determined to have enteritis resistant to medical therapy. A total colon resection was performed 88 days after the admission. Her condition gradually stabilized postoperatively, and oral intake was initiated and tolerated. The patient was transferred to another hospital for rehabilitation for home discharge. She is now at home and has had no recurrences. CONCLUSIONS In previous reports of surgical treatment for CMV enteritis, many cases were initially undiagnosed, emergency surgery was performed after perforation or stenosis was recognized, and then CMV was diagnosed and treated. In CMV enteritis without immunodeficiency, surgical treatment may be an option if medical treatment is ineffective.
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Affiliation(s)
- Sae Kawata
- Department of Emergency Medicine, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo, 660-0064, Japan.
| | - Jumpei Takamatsu
- Department of Emergency Medicine, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo, 660-0064, Japan
| | - Yuichi Yasue
- Department of Emergency Medicine, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo, 660-0064, Japan
| | - Aya Fukuhara
- Department of Emergency Medicine, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo, 660-0064, Japan
| | - Jinkoo Kang
- Department of Emergency Medicine, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo, 660-0064, Japan
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18
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Lauscher J, Beyer K, Hellinger A, Croner RS, Ridwelski K, Krautz C, Lim C, Coplan PM, Kurepkat M, Ribaric G. Impact of a digital surgical workflow including Digital Device Briefing Tool on morbidity and mortality in a patient population undergoing primary stapled colorectal anastomosis for benign or malignant colorectal disease: protocol for a multicentre prospective cohort study. BMJ Open 2023; 13:e070053. [PMID: 36972968 PMCID: PMC10069574 DOI: 10.1136/bmjopen-2022-070053] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/29/2023] Open
Abstract
INTRODUCTION With growing emphasis on surgical safety, it appears fundamental to assess the safety of colorectal resection involving primary stapled anastomosis. Surgical stapling devices can considerably foster patient safety in colorectal surgery, but their misuse or malfunction encompass a unique risk of postoperative complications. The Digital Device Briefing Tool (DDBT) is a digital cognitive aid developed to enhance safe use of the Ethicon circular stapling device during colorectal resection. The purpose of this study is to evaluate how a digital operative workflow, including DDBT, compared with routine surgical care, affects morbidity and mortality in patients undergoing left-sided colorectal resection with primary stapled colorectal anastomosis for colorectal cancer or benign disease. METHODS AND ANALYSIS A multicentre, prospective cohort study will be conducted at five certified academic colorectal centres in Germany. It compares a non-digital with a Johnson & Johnson digital solution (Surgical Process Institute Deutschland (SPI))-guided operative workflow in patients undergoing left hemicolectomy, sigmoidectomy, anterior rectal resection and Hartmann reversal procedure. The sample size is set at 528 cases in total, divided into 3 groups (a non-digital and two SPI-guided workflow cohorts, with and without DDBT) in a ratio of 1:1:1, with 176 patients each. The primary endpoint is a composite outcome comprising the overall rate of surgical complications, including death, during hospitalisation and within the first 30 days after colorectal resection. Secondary endpoints include operating time, length of hospital stay and 30-day hospital readmission rate. ETHICS AND DISSEMINATION This study will be performed in line with the Declaration of Helsinki. The ethics committee of the Charité-University Medicine Berlin, Germany, approved the study (No: 22-0277-EA2/060/22). Study Investigators will obtain written informed consent from each patient before a patient may participate in this study. The study results will be submitted to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER DRKS00029682.
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Affiliation(s)
- Johannes Lauscher
- Department of General and Visceral Surgery, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Berlin, Germany
| | - Katharina Beyer
- Department of General and Visceral Surgery, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Berlin, Germany
| | - Achim Hellinger
- Department of General, Visceral, Endocrine and Oncologic Surgery, Klinikum Fulda, Universitätsmedizin Marburg - Campus Fulda, Fulda, Germany
| | - Roland S Croner
- Department of General, Visceral, Vascular and Transplant Surgery, University Hospital Magdeburg, Otto von Guericke Universität Magdeburg, Magdeburg, Germany
| | - Karsten Ridwelski
- An-Institute of Quality Assurance in Operative Medicine, Otto von Guericke Universität Magdeburg, Magdeburg, Germany
- Clinic for General and Visceral Surgery, Klinikum Magdeburg gGmbH, Magdeburg, Germany
| | - Christian Krautz
- Department of General and Visceral Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany
| | - Christine Lim
- Johnson & Johnson MedTech Medical Safety, Johnson & Johnson World Headquarters US, New Brunswick, New Jersey, USA
| | - Paul M Coplan
- Department of Epidemiology, Office of the Chief Medical Officer, Johnson & Johnson World Headquarters US, New Brunswick, New Jersey, USA
- Adjunct, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA
| | - Marc Kurepkat
- CSG - Clinische Studien Gesellschaft mbH, Berlin, Germany
| | - Goran Ribaric
- Johnson & Johnson Institute Hamburg, Johnson & Johnson Medical GmbH, Norderstedt, Germany
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19
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Bawa D, Khalifa YM, Khan S, Norah W, Noman N. Surgical outcomes and prognostic factors associated with emergency left colonic surgery. Ann Saudi Med 2023; 43:97-104. [PMID: 37031374 PMCID: PMC10082940 DOI: 10.5144/0256-4947.2023.97] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 04/10/2023] Open
Abstract
BACKGROUND Mortality from emergency left-sided colorectal surgery can be substantial due to acuteness of the presentation and the urgent need to operate in the setting of a limited preparation in a morbid patient. OBJECTIVES Determine the 30-day postoperative outcomes and identify risk factors for complications and mortality following emergency colorectal operations. DESIGN Retrospective SETTINGS: Three tertiary hospitals in three countries. PATIENTS AND METHODS Factors that were studied included age, sex, ASA score, type and extent of the operation, and presence/absence of malignancy. Unadjusted 30-day patient outcomes examined were complications and mortality. Differences in proportions were assessed using the Pearson chi-square test while logistic regression analyses were carried out to evaluate the correlation between risk factors and outcomes. MAIN OUTCOME MEASURES 30-day postoperative morbidity and mortality SAMPLE SIZE: 104 patients. RESULTS Among 104 patients, 70 (67.3%) were men, and 34 (32.7%) were women. The mean (SD) age was 57.2 (17.1) years. The most common indication for emergency colonic surgery was malignant obstruction in 33 (31.7%) patients. The postoperative complication rate was 24% (25/104), and the mortality rate was 12.5% (13/104) within 30 days of the operation. The ASA status (P=.02), presence of malignancy (P=.02), and the presence of complications (P=.004) were significantly related to mortality in the multivariable logistic regression analysis. CONCLUSIONS The 30-day mortality of emergency colorectal operations is greatly influenced by the presence of malignancy in the colon and physiological status at the time of the procedure. LIMITATIONS The retrospective design and small sample size. CONFLICT OF INTEREST None.
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Affiliation(s)
- Dauda Bawa
- From the Department of Surgery, King Abdullah Hospital Bisha, RIyadh, Saudi Arabia
| | | | - Saleem Khan
- From the Department of Surgery, King Abdullah Hospital Bisha, RIyadh, Saudi Arabia
| | - Waddah Norah
- From the Department of Surgery, Haql General Hospital, Haql, Tabuk, Saudi Arabia
| | - Nibras Noman
- From the Department of Surgery, University of Liverpool, Merseyside, United Kingdom
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20
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Carpenter EL, Valdera FA, Chauviere MV, Krell RW. Outcomes of Partial Versus Total Colectomy in Ulcerative Colitis: A Propensity Score-Matched Analysis. J Surg Res 2023; 287:63-71. [PMID: 36868125 DOI: 10.1016/j.jss.2023.01.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2022] [Revised: 01/03/2023] [Accepted: 01/28/2023] [Indexed: 03/05/2023]
Abstract
INTRODUCTION Total abdominal colectomy (TAC) with ileostomy is the standard treatment for severe ulcerative colitis (UC). Partial colectomy (PC) with colostomy may present a less morbid treatment option. METHODS The 2012-19 ACS-NSQIP database was queried to assess 30-day outcomes among patients undergoing TAC versus PC for UC, utilizing propensity score matching (PSM) techniques to account for differences in disease severity, patient selection, and presentation acuity. RESULTS Before matching (n = 9888), patients undergoing PC were older, had more comorbidities, and experienced higher complication and 30-day mortality rates (P < 0.001). After matching (n = 1846), patients undergoing TAC experienced higher 30-day overall complications (41.9% versus 36.5%, P = 0.017) and serious complications (37.2% versus 31.5%, P = 0.011). Sensitivity analyses of older patients and those undergoing nonemergency surgery demonstrated higher overall rates of complications for patients receiving TAC. However, among patients undergoing emergency surgery only, no differences in complications were seen between the two surgical approaches. CONCLUSIONS PC with colostomy in the setting of ulcerative colitis has similar 30-day outcomes to TAC with ileostomy. PC may be an acceptable surgical alternative to TAC in select patients. Studies investigating longer-term outcomes are necessary to further investigate this option.
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Affiliation(s)
- Elizabeth L Carpenter
- Department of Surgery, San Antonio Military Medical Center, Fort Sam Houston, Texas.
| | - Franklin A Valdera
- Department of Surgery, San Antonio Military Medical Center, Fort Sam Houston, Texas
| | - Matthew V Chauviere
- Department of Surgery, San Antonio Military Medical Center, Fort Sam Houston, Texas
| | - Robert W Krell
- Department of Surgery, San Antonio Military Medical Center, Fort Sam Houston, Texas
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21
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Cira K, Weber MC, Wilhelm D, Friess H, Reischl S, Neumann PA. The Effect of Anti-Tumor Necrosis Factor-Alpha Therapy within 12 Weeks Prior to Surgery on Postoperative Complications in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. J Clin Med 2022; 11:6884. [PMID: 36498459 PMCID: PMC9738467 DOI: 10.3390/jcm11236884] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2022] [Revised: 11/07/2022] [Accepted: 11/12/2022] [Indexed: 11/24/2022] Open
Abstract
The rate of abdominal surgical interventions and associated postoperative complications in inflammatory bowel disease (IBD) patients is still substantially high. There is an ongoing debate as to whether or not patients who undergo treatment with anti-tumor necrosis factor-alpha (TNF-α) agents may have an increased risk for general and surgical postoperative complications. Therefore, a systematic review and meta-analysis was conducted in order to assess the effect of anti-TNF-α treatment within 12 weeks (washout period) prior to abdominal surgery on 30-day postoperative complications in patients with IBD. The results of previously published meta-analyses examining the effect of preoperative anti-TNF-α treatment on postoperative complications reported conflicting findings which is why we specifically focus on the effect of anti-TNF-α treatment within 12 weeks prior to surgery. PubMed, Cochrane, Scopus, Web of Science, World Health Organization Trial Registry, ClinicalTrials.gov and reference lists were searched (June 1995−February 2022) to identify studies, investigating effects of anti-TNF-α treatment prior to abdominal surgery on postoperative complications in IBD patients. Pooled odds ratios (OR) with 95% confidence intervals (CI) were calculated and subgroup analyses were performed. In this case, 55 cohort studies (22,714 patients) were included. Overall, postoperative complications (OR, 1.23; 95% CI, 1.04−1.45; p = 0.02), readmission (OR, 1.39; 95% CI, 1.11−1.73; p = 0.004), and intra-abdominal septic complications (OR, 1.89; 95% CI, 1.44−2.49; p < 0.00001) were significantly higher for anti-TNF-α-treated patients. Significantly higher intra-abdominal abscesses and readmission were found for anti-TNF-α-treated CD patients (p = 0.05; p = 0.002). Concomitant treatment with immunosuppressives in <50% of anti-TNF-α-treated patients was associated with significantly lower mortality rates (OR, 0.32; 95% CI, 0.12−0.83; p = 0.02). Anti-TNF-α treatment within 12 weeks prior to surgery is associated with higher short-term postoperative complication rates (general and surgical) for patients with IBD, especially CD.
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Affiliation(s)
- Kamacay Cira
- Department of Surgery, School of Medicine, Klinikum Rechts der Isar, Technical University of Munich, 81675 Munich, Germany
| | - Marie-Christin Weber
- Department of Surgery, School of Medicine, Klinikum Rechts der Isar, Technical University of Munich, 81675 Munich, Germany
| | - Dirk Wilhelm
- Department of Surgery, School of Medicine, Klinikum Rechts der Isar, Technical University of Munich, 81675 Munich, Germany
| | - Helmut Friess
- Department of Surgery, School of Medicine, Klinikum Rechts der Isar, Technical University of Munich, 81675 Munich, Germany
| | - Stefan Reischl
- Institute of Diagnostic and Interventional Radiology, School of Medicine, Klinikum Rechts der Isar, Technical University of Munich, 81675 Munich, Germany
| | - Philipp-Alexander Neumann
- Department of Surgery, School of Medicine, Klinikum Rechts der Isar, Technical University of Munich, 81675 Munich, Germany
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22
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Effect of Prophylactic Negative-Pressure Wound Therapy for High-Risk Wounds in Colorectal Cancer Surgery: A Randomized Controlled Trial. Adv Skin Wound Care 2022; 35:597-603. [DOI: 10.1097/01.asw.0000874168.60793.10] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
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23
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Charalambides M, Afxentiou T, Pellino G, Powar MP, Fearnhead NS, Davies RJ, Wheeler J, Simillis C. A systematic review and network meta-analysis comparing energy devices used in colorectal surgery. Tech Coloproctol 2022; 26:413-423. [PMID: 35132505 DOI: 10.1007/s10151-022-02586-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/03/2022] [Accepted: 01/26/2022] [Indexed: 10/19/2022]
Abstract
BACKGROUND The aim of this study was to compare energy devices used for intraoperative hemostasis during colorectal surgery. METHODS A systematic literature review and Bayesian network meta-analysis performed. MEDLINE, EMBASE, Science Citation Index Expanded, and Cochrane were searched from inception to August 11th 2021. Intraoperative outcomes were operative blood loss, operative time, conversion to open, conversion to another energy source. Postoperative outcomes were mortality, overall complications, minor complications and major complications, wound complications, postoperative ileus, anastomotic leak, time to first defecation, day 1 and 3 drainage volume, duration of hospital stay. RESULTS Seven randomized controlled trials (RCTs) were included, reporting on 680 participants, comparing conventional hemostasis, LigaSure™, Thunderbeat® and Harmonic®. Harmonic® had fewer overall complications compared to conventional hemostasis. Operative blood loss was less with LigaSure™ (mean difference [MD] = 24.1 ml; 95% confidence interval [CI] - 46.54 to - 1.58 ml) or Harmonic® (MD = 24.6 ml; 95% CI - 42.4 to - 6.7 ml) compared to conventional techniques. Conventional hemostasis ranked worst for operative blood loss with high probability (p = 0.98). LigaSure™, Harmonic® or Thunderbeat® resulted in a significantly shorter mean operative time by 42.8 min (95% CI - 53.9 to - 31.5 min), 28.3 min (95% CI - 33.6 to - 22.6 min) and 26.1 min (95% CI - 46 to - 6 min), respectively compared to conventional electrosurgery. LigaSure™ resulted in a significantly shorter mean operative time than Harmonic® by 14.5 min (95% CI 1.9-27 min) and ranked first for operative time with high probability (p = 0.97). LigaSure™ and Harmonic® resulted in a significantly shorter mean duration of hospital stay compared to conventional electrosurgery of 1.3 days (95% CI - 2.2 to - 0.4) and 0.5 days (95% CI - 1 to - 0.1), respectively. LigaSure™ ranked as best for hospital stay with high probability (p = 0.97). Conventional hemostasis was associated with more wound complications than Harmonic® (odds ratio [OR] = 0.27; CI 0.08-0.92). Harmonic® ranked best with highest probability (p = 0.99) for wound complications. No significant differences between energy devices were identified for the remaining outcomes. CONCLUSIONS LigaSure™, Thunderbeat® and Harmonic® may be advantageous for reducing operative blood loss, operative time, overall complications, wound complications, and duration of hospital stay compared to conventional techniques. The energy devices result in comparable perioperative outcomes and no device is superior overall. However, included RCTs were limited in number and size, and data were not available to compare all energy devices for all outcomes of interest.
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Affiliation(s)
- M Charalambides
- Cambridge Colorectal Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK
| | - T Afxentiou
- Cambridge Colorectal Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK
| | - G Pellino
- Department of Advanced Medical and Surgical Sciences, Università degli Studi della Campania "Luigi Vanvitelli", Naples, Italy
| | - M P Powar
- Cambridge Colorectal Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK
| | - N S Fearnhead
- Cambridge Colorectal Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK
| | - R J Davies
- Cambridge Colorectal Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK
| | - J Wheeler
- Cambridge Colorectal Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK
| | - C Simillis
- Cambridge Colorectal Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK.
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24
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Hanzel J, Almradi A, Istl AC, Yang ML, Fleshner KA, Parker CE, Guizzetti L, Ma C, Singh S, Jairath V. Increased Risk of Infections with Anti-TNF Agents in Patients with Crohn's Disease After Elective Surgery: Meta-Analysis. Dig Dis Sci 2022; 67:646-660. [PMID: 33634430 DOI: 10.1007/s10620-021-06895-6] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/15/2020] [Accepted: 02/03/2021] [Indexed: 12/12/2022]
Abstract
BACKGROUND Postoperative complication rates in patients with inflammatory bowel disease (IBD) receiving preoperative biologics have been analyzed without considering the surgical context. Emergency surgery may be associated with an increased risk of infectious complications, compared to elective operations. AIMS To conduct a systematic review and meta-analysis investigating the relationship between preoperative biologic therapy and postoperative outcomes in Crohn's disease (CD) and ulcerative colitis (UC), focusing on elective surgery. METHODS Electronic databases were searched up to February 12, 2020, for studies of patients with IBD undergoing elective abdominal surgery receiving biologic therapy within 3 months before surgery compared to no therapy, or another biologic therapy. Certainty of evidence was evaluated using GRADE. The primary outcomes were the rate of infections and total complications within 30 days. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS Thirty-three studies were included. Preoperative treatment with anti-tumor necrosis factor (TNF) therapy in patients with CD undergoing elective surgery was associated with increased odds of infection (OR 2.05; 95% CI 1.40-3.01), but not total complications (OR 1.03; 95% CI 0.71-1.51). In elective surgery for UC, preoperative anti-TNF therapy was not associated with infectious (OR 1.03; 95% CI 0.34-3.07) or total complications (OR 0.67; 95% CI 0.29-1.58). Limited data indicate that emergency surgery did not significantly affect the rate of complications. CONCLUSIONS Anti-TNF therapy prior to elective surgery may increase the odds of postoperative infection in CD, although the certainty of evidence is very low. More evidence is needed, particularly for newer biologics.
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Affiliation(s)
- Jurij Hanzel
- Department of Gastroenterology, UMC Ljubljana, University of Ljubljana, Japljeva ulica 2, 1000, Ljubljana, Slovenia.,Alimentiv Inc. (Formerly Robarts Clinical Trials Inc.), 100 Dundas Street, Suite 200, London, ON, 27N6A 5B6, Canada
| | - Ahmed Almradi
- Alimentiv Inc. (Formerly Robarts Clinical Trials Inc.), 100 Dundas Street, Suite 200, London, ON, 27N6A 5B6, Canada.,Department of Medicine, Division of Gastroenterology, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada
| | - Alexandra C Istl
- Division of General Surgery, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada
| | - Mei Lucy Yang
- Division of General Surgery, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada
| | - Katherine A Fleshner
- Schulich School of Medicine and Dentistry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada
| | - Claire E Parker
- Alimentiv Inc. (Formerly Robarts Clinical Trials Inc.), 100 Dundas Street, Suite 200, London, ON, 27N6A 5B6, Canada
| | - Leonardo Guizzetti
- Alimentiv Inc. (Formerly Robarts Clinical Trials Inc.), 100 Dundas Street, Suite 200, London, ON, 27N6A 5B6, Canada
| | - Christopher Ma
- Alimentiv Inc. (Formerly Robarts Clinical Trials Inc.), 100 Dundas Street, Suite 200, London, ON, 27N6A 5B6, Canada.,Division of Gastroenterology and Hepatology, Departments of Medicine and Community Health Sciences, University of Calgary, 2500 University Dr NW, Calgary, AB, T2N 1N4, Canada
| | - Siddharth Singh
- Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, 9500 Gilman Dr, La Jolla, CA, 92093, USA
| | - Vipul Jairath
- Alimentiv Inc. (Formerly Robarts Clinical Trials Inc.), 100 Dundas Street, Suite 200, London, ON, 27N6A 5B6, Canada. .,Department of Medicine, Division of Gastroenterology, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada. .,Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.
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25
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A systematic review of the literature assessing operative blood loss and postoperative outcomes after colorectal surgery. Int J Colorectal Dis 2022; 37:47-69. [PMID: 34697662 DOI: 10.1007/s00384-021-04015-4] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/19/2021] [Indexed: 02/04/2023]
Abstract
PURPOSE There is no consensus in the literature regarding the association between operative blood loss and postoperative outcomes in colorectal surgery, despite evidence suggesting a link. Therefore, this systematic review assesses the association between operative blood loss, perioperative and long-term outcomes after colorectal surgery. METHODS A literature search of MEDLINE, EMBASE, Science Citation Index Expanded and Cochrane was performed to identify studies reporting on operative blood loss in colorectal surgery. RESULTS The review included forty-nine studies reporting on 61,312 participants, with a mean age ranging from 53.4 to 78.1 years. The included studies demonstrated that major operative blood loss was found to be a risk factor for mortality, anastomotic leak, presacral abscess, and postoperative ileus, leading to an increased duration of hospital stay. In the long term, the studies suggest that significant blood loss was an independent risk factor for future small bowel obstruction due to colorectal cancer recurrence and adhesions. Studies found that survival was significantly reduced, whilst the risk of colorectal cancer recurrence was increased. Reoperation and cancer-specific survival were not associated with major blood loss. CONCLUSION The results of this systematic review suggest that major operative blood loss increases the risk of perioperative adverse events and has short and long-term repercussions on postoperative outcomes. Laparoscopic and robotic surgery, vessel ligation technology and anaesthetic considerations are essential for reducing blood loss and improving outcomes. This review highlights the need for further high quality, prospective, multicentre trials with a greater number of participants, and accurate and standardised methods of measuring operative blood loss.
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26
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Zafer M, Zhang H, Dwadasi S, Goens D, Paknikar R, Dalal S, Cohen RD, Pekow J, Rubin DT, Sakuraba A, Micic D. A Clinical Predictive Model for One-year Colectomy in Adults Hospitalized for Severe Ulcerative Colitis. CROHN'S & COLITIS 360 2021; 4:otab082. [PMID: 36777555 PMCID: PMC9802419 DOI: 10.1093/crocol/otab082] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/21/2021] [Indexed: 11/13/2022] Open
Abstract
Background Models to predict colectomy in ulcerative colitis (UC) are valuable for identification, clinical management, and follow-up of high-risk patients. Our aim was to develop a clinical predictive model based on admission data for one-year colectomy in adults hospitalized for severe UC. Methods We performed a retrospective analysis of patients hospitalized at a tertiary academic center for management of severe UC from 1/2013 to 4/2018. Multivariate regression was performed to identify individual predictors of one-year colectomy. Outcome probabilities of colectomy based on the prognostic score were estimated using a bootstrapping technique. Results Two hundred twenty-nine individuals were included in the final analytic cohort. Four independent variables were associated with one-year colectomy which were incorporated into a point scoring system: (+) 1 for single class biologic exposure prior to admission; (+) 2 for multiple classes of biologic exposure; (+) 1 for inpatient salvage therapy with cyclosporine or a TNF-alpha inhibitor; (+) 1 for age <40. The risk probabilities of colectomy within one year in patients assigned scores 1, 2, 3, and 4 were 9.4% (95% CI, 1.7-17.2), 33.7% (95% CI, 23.9-43.5), 58.5% (95% CI, 42.9-74.1), 75.0% (95% CI, 50.5-99.5). An assigned score of zero was a perfect predictor of no colectomy. Conclusion Risk factors most associated with one-year colectomy for severe UC included: prior biologic exposure, need for inpatient salvage therapy, and younger age. We developed a simple scoring system using these variables to identify and stratify patients during their index hospitalization.
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Affiliation(s)
- Maryam Zafer
- Department of Internal Medicine, University of Chicago Medicine, Chicago, IL, USA
| | - Hui Zhang
- The Center for Health and the Social Sciences, University of Chicago, Chicago, IL, USA
| | - Sujaata Dwadasi
- Department of Internal Medicine, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, IL, USA
| | - Donald Goens
- Department of Internal Medicine, University of Chicago Medicine, Chicago, IL, USA
| | - Raghavendra Paknikar
- Department of Internal Medicine, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, IL, USA
| | - Sushila Dalal
- Department of Internal Medicine, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, IL, USA
| | - Russell D Cohen
- Department of Internal Medicine, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, IL, USA
| | - Joel Pekow
- Department of Internal Medicine, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, IL, USA
| | - David T Rubin
- Department of Internal Medicine, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, IL, USA
| | - Atsushi Sakuraba
- Department of Internal Medicine, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, IL, USA
| | - Dejan Micic
- Department of Internal Medicine, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, IL, USA,Address correspondence to: Dejan Micic, MD, 5841 South Maryland Avenue, MC4076, Chicago, IL 60637, USA. Telephone: 773-702-9200 ()
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27
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Optimal Placement of Colectomy in the Treatment of Ulcerative Colitis: a Markov Model Analysis. J Gastrointest Surg 2021; 25:3208-3217. [PMID: 34725785 DOI: 10.1007/s11605-021-05180-1] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/16/2021] [Accepted: 10/14/2021] [Indexed: 01/31/2023]
Abstract
BACKGROUND Treatment for moderate-to-severe ulcerative colitis (UC) includes medical therapies such as immunosuppressive agents or surgical options such as colectomy. While prior studies have indicated a mortality benefit with elective surgery, the timing and effectiveness of colectomy in the UC treatment algorithm have not been assessed. We hypothesize that the ideal placement of colectomy occurs prior to the exhaustion of all medical therapies. METHODS We designed a Markov model to assess the ideal position of colectomy. The base case was a 50-year-old male with steroid-dependent moderate-to-severe UC without prior treatment with immunomodulator or biologic therapies. We developed 4 separate algorithms incorporating elective colectomy: (1) prior to biologics, (2) after infliximab monotherapy failure, (3) after infliximab and azathioprine combination therapy failure, and (4) after medically refractory to all medical therapies including vedolizumab. Transition probabilities were obtained from published literature. First-order Monte Carlo simulations of 100 trials of 100,000 individuals were used to calculate quality-adjusted life-year (QALY) estimates. One-way sensitivity analyses were conducted for all variables. RESULTS Algorithm 3 (colectomy following combination therapy) was the preferred strategy with 1.864 QALYs (95% CI [1.863, 1.865]) over a 3-year period and the preferred strategy in the probabilistic sensitivity analysis 92.77% of the time. CONCLUSIONS This simulation suggests that early incorporation of colectomy for patients medically refractory to infliximab and azathioprine combination therapy may yield greater quality of life for patients with steroid-dependent UC. These findings suggest avenues for more patient-centered preference work and a combined medical-surgical approach to UC.
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Del Valle JP, Lee GC, Serrato JC, Feuerstein JD, Bordeianou LG, Hodin R, Kunitake H, Poylin V. Recurrence of Clostridium Difficile and Cytomegalovirus Infections in Patients with Ulcerative Colitis Who Undergo Ileal Pouch-Anal Anastomosis. Dig Dis Sci 2021; 66:4441-4447. [PMID: 33433814 DOI: 10.1007/s10620-020-06772-8] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 12/04/2020] [Indexed: 01/13/2023]
Abstract
BACKGROUND Patients with ulcerative colitis (UC) are at increased risk for infections such as Clostridium difficile and cytomegalovirus (CMV) colitis due to chronic immunosuppression. These patients often undergo multiple surgeries putting them at risk for recurrence of the infection. However, rates of recurrence in this setting and outcomes are not well understood. AIM The aim of this study is to determine rates of recurrence of C difficile and CMV infection in patients undergoing multistage UC surgeries and effects of antibiotic prophylaxis on outcomes. METHODS All patients with UC who underwent IPAA between 2001 and 2017 (at two tertiary referral centers were identified. History of C. difficile or CMV colitis prior to any surgery and recurrence after IPAA was noted RESULTS: A total of 633 patients with UC who underwent IPAA were identified, of whom 8.1% patients had C. difficile and 2.7% had CMV infections. 9.8% of C. difficile and 5.9% of CMV patients recurred after IPAA. Rates of abdominal sepsis (14.7% vs. 12.7%), 90-day mortality (0% vs. 0.4%), pouchitis (36.8% vs. 45.0%), or return to stoma (7.4% vs. 5.4%) were similar between patients who did or did not have infections. In patients with C. difficile infection prior to first surgery, none of the patients who received prophylaxis had recurrent infection. CONCLUSIONS Rates of C. difficile and CMV infections remain high in patients undergoing surgery for UC, with substantial minority developing recurrent infection during subsequent surgical procedures. Antibiotic prophylaxis in patients with a history of C difficile may reduce the rate of recurrent infection.
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Affiliation(s)
- Jonathan Pastrana Del Valle
- Department of Surgery, Beth Israel Deaconess Medical Center, Beth Israel Deaconess Medical Center Suite 9B, 110 Francis Street, Boston, MA, 02215, USA
- Harvard Medical School, Boston, MA, USA
| | - Grace C Lee
- Division of Gastrointestinal and Oncologic Surgery, Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA
- Harvard Medical School, Boston, MA, USA
| | - Jose Cataneo Serrato
- Department of Surgery, Beth Israel Deaconess Medical Center, Beth Israel Deaconess Medical Center Suite 9B, 110 Francis Street, Boston, MA, 02215, USA
- Division of Gastrointestinal and Oncologic Surgery, Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA
- Harvard Medical School, Boston, MA, USA
| | - Joseph D Feuerstein
- Division of Gastroenterology, Beth Israel Deaconess Medical Center Medicine, 330 Brookline Ave, Boston, MA, 02215, USA
- Harvard Medical School, Boston, MA, USA
| | - Liliana Grigorievna Bordeianou
- Division of Gastrointestinal and Oncologic Surgery, Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA
- Harvard Medical School, Boston, MA, USA
| | - Richard Hodin
- Division of Gastrointestinal and Oncologic Surgery, Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA
- Harvard Medical School, Boston, MA, USA
| | - Hiroko Kunitake
- Harvard Medical School, Boston, MA, USA
- Advocate Illinois Masonic Medical Center, 836 W Wellington Ave, Chicago, IL, 60657, USA
| | - Vitaliy Poylin
- Division of Gastrointestinal and Oncologic Surgery, Northwestern Medicine, Arkes Family Pavilion, 676 North Saint Clair Street, Suite 650, Chicago, IL, 60611, USA.
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Dulai PS, Jairath V. A Microsimulation Model to Project the 5-Year Impact of Using Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Acute Flares. Dig Dis Sci 2021; 66:3740-3752. [PMID: 33185788 PMCID: PMC9035275 DOI: 10.1007/s10620-020-06707-3] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/20/2020] [Accepted: 11/02/2020] [Indexed: 12/15/2022]
Abstract
BACKGROUND Hyperbaric oxygen therapy (HBOT) improves short-term outcomes for ulcerative colitis (UC) patients hospitalized for acute flares. Longer-term impacts and cost-effectiveness are unknown. METHODS We compared disease outcomes and cost-effectiveness of HBOT in addition to standard of care versus standard of care alone for UC patients hospitalized for acute flares using a microsimulation model. Published literature was used for transition probabilities, costs, and quality-adjusted life year (QALY) estimates. We modeled 100,000 individuals in each group over a 5-year horizon and compared rates of re-hospitalization, rescue medical therapy, colectomy, death, and cost-effectiveness at a willingness-to-pay of $100,000/QALY. Probabilistic sensitivity analyses were performed with 500 samples and 250 trials, in addition to multiple microsimulation sensitivity analyses. RESULTS The use of HBOT at the time of index hospitalization for an acute UC flare is projected to reduce the risk of re-hospitalization, inpatient rescue medical therapy, and inpatient emergent colectomy by over 60% (p < 0.001) and mortality by over 30% (p <0.001), during a 5-year horizon. The HBOT strategy costs more ($5600 incremental cost) but also yielded higher QALYs (0.13 incremental yield), resulting in this strategy being cost-effective ($43,000/QALY). Results were sensitive to HBOT costs and rates of endoscopic improvement with HBOT. Probabilistic sensitivity analyses observed HBOT to be more cost-effective than standard of care in 95% of iterations. CONCLUSION The use of HBOT to optimize response to steroids during the index hospitalization for an acute UC flare is cost-effective and is projected to result in significant reductions in disease-related complications in the long term.
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Affiliation(s)
- Parambir S Dulai
- Division of Gastroenterology, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.
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30
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García MJ, Rivero M, Miranda-Bautista J, Bastón-Rey I, Mesonero F, Leo-Carnerero E, Casas-Deza D, Cagigas Fernández C, Martin-Cardona A, El Hajra I, Hernández-Aretxabaleta N, Pérez-Martínez I, Fuentes-Valenzuela E, Jiménez N, Rubín de Célix C, Gutiérrez A, Suárez Ferrer C, Huguet JM, Fernández-Clotet A, González-Vivó M, Del Val B, Castro-Poceiro J, Melcarne L, Dueñas C, Izquierdo M, Monfort D, Bouhmidi A, Ramírez De la Piscina P, Romero E, Molina G, Zorrilla J, Calvino-Suárez C, Sánchez E, Nuñez A, Sierra O, Castro B, Zabana Y, González-Partida I, De la Maza S, Castaño A, Nájera-Muñoz R, Sánchez-Guillén L, Riat Castro M, Rueda JL, Benítez JM, Delgado-Guillena P, Tardillo C, Peña E, Frago-Larramona S, Rodríguez-Grau MC, Plaza R, Pérez-Galindo P, Martínez-Cadilla J, Menchén L, Barreiro-De Acosta M, Sánchez-Aldehuelo R, De la Cruz MD, Lamuela LJ, Marín I, Nieto-García L, López-San Román A, Herrera JM, Chaparro M, Gisbert JP, on behalf of the Young Group of GETECCU. Impact of Biological Agents on Postsurgical Complications in Inflammatory Bowel Disease: A Multicentre Study of Geteccu. J Clin Med 2021; 10:4402. [PMID: 34640421 PMCID: PMC8509475 DOI: 10.3390/jcm10194402] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/07/2021] [Revised: 09/23/2021] [Accepted: 09/24/2021] [Indexed: 12/18/2022] Open
Abstract
BACKGROUND The impact of biologics on the risk of postoperative complications (PC) in inflammatory bowel disease (IBD) is still an ongoing debate. This lack of evidence is more relevant for ustekinumab and vedolizumab. AIMS To evaluate the impact of biologics on the risk of PC. METHODS A retrospective study was performed in 37 centres. Patients treated with biologics within 12 weeks before surgery were considered "exposed". The impact of the exposure on the risk of 30-day PC and the risk of infections was assessed by logistic regression and propensity score-matched analysis. RESULTS A total of 1535 surgeries were performed on 1370 patients. Of them, 711 surgeries were conducted in the exposed cohort (584 anti-TNF, 58 vedolizumab and 69 ustekinumab). In the multivariate analysis, male gender (OR: 1.5; 95% CI: 1.2-2.0), urgent surgery (OR: 1.6; 95% CI: 1.2-2.2), laparotomy approach (OR: 1.5; 95% CI: 1.1-1.9) and severe anaemia (OR: 1.8; 95% CI: 1.3-2.6) had higher risk of PC, while academic hospitals had significantly lower risk. Exposure to biologics (either anti-TNF, vedolizumab or ustekinumab) did not increase the risk of PC (OR: 1.2; 95% CI: 0.97-1.58), although it could be a risk factor for postoperative infections (OR 1.5; 95% CI: 1.03-2.27). CONCLUSIONS Preoperative administration of biologics does not seem to be a risk factor for overall PC, although it may be so for postoperative infections.
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Affiliation(s)
- María José García
- Gastroenterology Department, Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria, Instituto de Investigación Sanitaria Valdecilla (IDIVAL), 37008 Santander, Spain; (M.R.); (B.C.)
| | - Montserrat Rivero
- Gastroenterology Department, Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria, Instituto de Investigación Sanitaria Valdecilla (IDIVAL), 37008 Santander, Spain; (M.R.); (B.C.)
| | - José Miranda-Bautista
- Gastroenterology Department, Hospital Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), and Departamento de Medicina, Universidad Complutense, 28009 Madrid, Spain; (J.M.-B.); (L.M.); (I.M.)
| | - Iria Bastón-Rey
- Gastroenterology Department, Hospital Universitario Clínico de Santiago, 15706 Santiago de Compostela, Spain; (I.B.-R.); (C.C.-S.); (M.B.-D.A.); (L.N.-G.)
| | - Francisco Mesonero
- Gastroenterology Department, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (F.M.); (E.S.); (R.S.-A.); (A.L.-S.R.)
| | - Eduardo Leo-Carnerero
- Gastroenterology Department, Hospital Universitario Virgen del Rocío, 41013 Sevilla, Spain; (E.L.-C.); (A.N.); (M.D.D.l.C.); (J.M.H.)
| | - Diego Casas-Deza
- Gastroenterology Department, Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IISA), 50009 Zaragoza, Spain; (D.C.-D.); (O.S.); (L.J.L.)
| | - Carmen Cagigas Fernández
- Colorectal Unit, Department of General and Digestive Surgery, Hospital Universitario Marqués de Valdecilla, 39008 Santander, Spain;
| | - Albert Martin-Cardona
- Gastroenterology Department, Hospital Universitari Mútua Terrassa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), 08221 Terrassa, Spain; (A.M.-C.); (Y.Z.)
| | - Ismael El Hajra
- Gastroenterology Department, Hospital Universitario Puerta de Hierro, 28220 Majadahonda, Spain; (I.E.H.); (I.G.-P.)
| | | | - Isabel Pérez-Martínez
- Department of Gastroenterology, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), 33011 Oviedo, Spain; (I.P.-M.); (A.C.)
| | - Esteban Fuentes-Valenzuela
- Gastroenterology Department, Hospital Universitario Río Hortega, 47012 Valladolid, Spain; (E.F.-V.); (R.N.-M.)
| | - Nuria Jiménez
- Gastroenterology Department, Hospital General Universitario de Elche, 03203 Alicante, Spain;
| | - Cristina Rubín de Célix
- Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), 28006 Madrid, Spain; (C.R.d.C.); (M.R.C.); (M.C.); (J.P.G.)
| | - Ana Gutiérrez
- Gastroenterology Department, Hospital General de Alicante, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), 03010 Alicante, Spain;
| | - Cristina Suárez Ferrer
- Gastroenterology Department, Hospital Universitario La Paz, 28046 Madrid, Spain; (C.S.F.); (J.L.R.)
| | - José María Huguet
- Gastroenterology Department, Hospital General Universitario de Valencia, 46014 Valencia, Spain;
| | | | | | - Blanca Del Val
- Gastroenterology Department, Hospital Rafael Méndez, 30817 Lorca, Spain;
| | - Jesús Castro-Poceiro
- Gastroenterology Department, Hospital Sant Joan Despí-Moisès Broggi, 08970 Barcelona, Spain;
| | - Luigi Melcarne
- Gastroenterology Department, Hospital Universitari Parc Taulí, Sabadell, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), 08208 Barcelona, Spain;
| | - Carmen Dueñas
- Gastroenterology Department, Hospital Universitario de Cáceres, 10003 Cáceres, Spain;
| | - Marta Izquierdo
- Gastroenterology Department, Hospital Universitario de Cabueñes, 33203 Gijón, Spain;
| | - David Monfort
- Gastroenterology Department, Consorcio Sanitario de Terrasa, 08227 Barcelona, Spain;
| | - Abdel Bouhmidi
- Gastroenterology Department, Hospital de Santa Bárbara, 13500 Puertollano, Spain;
| | | | - Eva Romero
- Gastroenterology Department, Hospital Clínico Universitario de Valencia, 46010 Valencia, Spain;
| | - Gema Molina
- Gastroenterology Department, Hospital Arquitecto Marcide, 15405 Ferrol, Spain;
| | - Jaime Zorrilla
- Department of Colorectal and Gastrointestinal Surgery, Hospital Universitario Gregorio Marañón, 28009 Madrid, Spain;
| | - Cristina Calvino-Suárez
- Gastroenterology Department, Hospital Universitario Clínico de Santiago, 15706 Santiago de Compostela, Spain; (I.B.-R.); (C.C.-S.); (M.B.-D.A.); (L.N.-G.)
| | - Eugenia Sánchez
- Gastroenterology Department, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (F.M.); (E.S.); (R.S.-A.); (A.L.-S.R.)
| | - Andrea Nuñez
- Gastroenterology Department, Hospital Universitario Virgen del Rocío, 41013 Sevilla, Spain; (E.L.-C.); (A.N.); (M.D.D.l.C.); (J.M.H.)
| | - Olivia Sierra
- Gastroenterology Department, Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IISA), 50009 Zaragoza, Spain; (D.C.-D.); (O.S.); (L.J.L.)
| | - Beatriz Castro
- Gastroenterology Department, Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria, Instituto de Investigación Sanitaria Valdecilla (IDIVAL), 37008 Santander, Spain; (M.R.); (B.C.)
| | - Yamile Zabana
- Gastroenterology Department, Hospital Universitari Mútua Terrassa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), 08221 Terrassa, Spain; (A.M.-C.); (Y.Z.)
| | - Irene González-Partida
- Gastroenterology Department, Hospital Universitario Puerta de Hierro, 28220 Majadahonda, Spain; (I.E.H.); (I.G.-P.)
| | - Saioa De la Maza
- Gastroenterology Department, Hospital Universitario de Basurto, 48013 Bilbao, Spain; (N.H.-A.); (S.D.l.M.)
| | - Andrés Castaño
- Department of Gastroenterology, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), 33011 Oviedo, Spain; (I.P.-M.); (A.C.)
| | - Rodrigo Nájera-Muñoz
- Gastroenterology Department, Hospital Universitario Río Hortega, 47012 Valladolid, Spain; (E.F.-V.); (R.N.-M.)
| | - Luis Sánchez-Guillén
- Department of Colorectal and Gastrointestinal Surgery, Hospital General Universitario de Elche, 03203 Alicante, Spain;
| | - Micaela Riat Castro
- Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), 28006 Madrid, Spain; (C.R.d.C.); (M.R.C.); (M.C.); (J.P.G.)
| | - José Luis Rueda
- Gastroenterology Department, Hospital Universitario La Paz, 28046 Madrid, Spain; (C.S.F.); (J.L.R.)
| | - José Manuel Benítez
- Gastroenterology Department, Hospital Reina Sofía, IMIBIC, 14004 Córdoba, Spain;
| | | | - Carlos Tardillo
- Gastroenterology Department, Hospital Nuestra Señora de la Candelaria, 38010 Tenerife, Spain;
| | - Elena Peña
- Gastroenterology Department, Hospital Royo Villanova, 50007 Zaragoza, Spain;
| | | | | | - Rocío Plaza
- Gastroenterology Department, Hospital Universitario Infanta Leonor, Vallecas, 28031 Madrid, Spain;
| | - Pablo Pérez-Galindo
- Gastroenterology Department, Complejo Hospitalario Universitario de Pontevedra, 36071 Pontevedra, Spain;
| | | | - Luis Menchén
- Gastroenterology Department, Hospital Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), and Departamento de Medicina, Universidad Complutense, 28009 Madrid, Spain; (J.M.-B.); (L.M.); (I.M.)
| | - Manuel Barreiro-De Acosta
- Gastroenterology Department, Hospital Universitario Clínico de Santiago, 15706 Santiago de Compostela, Spain; (I.B.-R.); (C.C.-S.); (M.B.-D.A.); (L.N.-G.)
| | - Rubén Sánchez-Aldehuelo
- Gastroenterology Department, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (F.M.); (E.S.); (R.S.-A.); (A.L.-S.R.)
| | - María Dolores De la Cruz
- Gastroenterology Department, Hospital Universitario Virgen del Rocío, 41013 Sevilla, Spain; (E.L.-C.); (A.N.); (M.D.D.l.C.); (J.M.H.)
| | - Luis Javier Lamuela
- Gastroenterology Department, Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón (IISA), 50009 Zaragoza, Spain; (D.C.-D.); (O.S.); (L.J.L.)
| | - Ignacio Marín
- Gastroenterology Department, Hospital Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), and Departamento de Medicina, Universidad Complutense, 28009 Madrid, Spain; (J.M.-B.); (L.M.); (I.M.)
| | - Laura Nieto-García
- Gastroenterology Department, Hospital Universitario Clínico de Santiago, 15706 Santiago de Compostela, Spain; (I.B.-R.); (C.C.-S.); (M.B.-D.A.); (L.N.-G.)
| | - Antonio López-San Román
- Gastroenterology Department, Hospital Universitario Ramón y Cajal, 28034 Madrid, Spain; (F.M.); (E.S.); (R.S.-A.); (A.L.-S.R.)
| | - José Manuel Herrera
- Gastroenterology Department, Hospital Universitario Virgen del Rocío, 41013 Sevilla, Spain; (E.L.-C.); (A.N.); (M.D.D.l.C.); (J.M.H.)
| | - María Chaparro
- Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), 28006 Madrid, Spain; (C.R.d.C.); (M.R.C.); (M.C.); (J.P.G.)
| | - Javier P. Gisbert
- Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), 28006 Madrid, Spain; (C.R.d.C.); (M.R.C.); (M.C.); (J.P.G.)
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Preoperative Neutrophil-to-Lymphocyte Ratio Is Correlated with Severe Postoperative Complications After Emergency Surgery for Ulcerative Colitis. Int Surg 2021. [DOI: 10.9738/intsurg-d-16-00216.1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
Abstract
Introduction
The incidence of postoperative severe complications is reported to be high in patients undergoing emergency surgery for severe ulcerative colitis (UC). It has also been reported that the preoperative inflammatory status is associated with the frequency of postoperative complications. The neutrophil-to-lymphocyte ratio (NLR) is a simple and useful parameter for determining the inflammatory status.
Methods
In the present study, we retrospectively investigated the correlation between the NLR and the incidence of severe postoperative complications in patients undergoing emergency surgery for severe UC. A total of 105 UC patients who underwent emergency or semi-emergency surgery were enrolled. Various clinical factors and NLR values were evaluated to identify the risk factors for severe complications. Postoperative complications were stratified by their severity according to the Clavien-Dindo Classification (CD). A postoperative complication of CD IIIb or higher was defined as severe postoperative complications. The incidence of severe complications was 16.2%.
Results
A multivariate analysis revealed the ASA score, toxic megacolon, and NLR to be independent risk factors for severe postoperative complications.
Conclusions
The results of this retrospective study suggest that the NLR is an independent risk factor for severe postoperative complications in patients undergoing emergency surgery for UC.
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Lightner AL, Vaidya P, Holubar S, Warusavitarne J, Sahnan K, Carrano FM, Spinelli A, Zaghiyan K, Fleshner PR. Perioperative safety of tofacitinib in surgical ulcerative colitis patients. Colorectal Dis 2021; 23:2085-2090. [PMID: 33942470 DOI: 10.1111/codi.15702] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/21/2020] [Revised: 02/03/2021] [Accepted: 03/11/2021] [Indexed: 01/19/2023]
Abstract
AIM The literature regarding monoclonal antibodies and increased postoperative complications in inflammatory bowel disease remains controversial. There have been no studies investigating tofacitinib. The aim of this work was to determine preoperative exposure to the small-molecule inhibitor tofacitinib and postoperative outcomes. METHOD We conducted a retrospective review of all adult patients exposed to tofacitinib within 4 weeks of total abdominal colectomy for medically refractory ulcerative colitis between 1 January 2018 and 1 September 2020 at four inflammatory bowel disease referral centres. Data collected included patient demographics and 90-day postoperative morbidity, readmission and reoperation rates. RESULTS Fifty-three patients (32 men, 60%) with ulcerative colitis underwent a total abdominal colectomy (n = 50 laparoscopic, 94%) for medically refractory disease. Previous exposure to monoclonal antibodies included infliximab (n = 34), adalimumab (n = 35), certolizumab pegol (n = 5), vedolizumab (n = 33) and ustekinumab (n = 10). Twenty-seven (51%) patients were on concurrent prednisone at a median daily dose of 30 mg by mouth (range 5-60 mg). There were no postoperative deaths. Ninety-day postoperative complications included ileus (n = 7, 13.2%), superficial surgical site infection (n = 4, 7.5%), intra-abdominal abscess (n = 2, 3.8%) and venous thromboembolism (VTE) (n = 7, 13.2%). Locations of VTE included portomesenteric venous thrombus (n = 4), internal iliac vein (n = 2) and pulmonary embolism (n = 1). Nine (17%) patients were readmitted to hospital and five (9%) patients had a reoperation. CONCLUSION Mirroring the recently issued US Food and Drug Administration black box warning of an increased risk of VTE in medically treated ulcerative colitis patients taking tofacitinib, preoperative tofacitinib exposure may present an increased risk of postoperative VTE events. Consideration should be given for prolonged VTE prophylaxis on hospital discharge.
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Affiliation(s)
- Amy L Lightner
- Department of Colorectal Surgery, Cleveland Clinic, Cleveland, OH, USA
| | - Prashansha Vaidya
- Department of Colorectal Surgery, Cleveland Clinic, Cleveland, OH, USA
| | - Stefan Holubar
- Department of Colorectal Surgery, Cleveland Clinic, Cleveland, OH, USA
| | | | - Kapil Sahnan
- Division of Colon and Rectal Surgery, St Marks Hospital, London, UK
| | - Francesco Maria Carrano
- Division of Colon and Rectal Surgery, Humanitas Clinical and Research Center, Colon and Rectal Surgery Unit, Rozzano, Milan, Italy.,Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy
| | - Antonino Spinelli
- Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy
| | - Karen Zaghiyan
- Division of Colon and Rectal Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Phillip R Fleshner
- Division of Colon and Rectal Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA
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Louis M, Johnston SA, Churilov L, Ma R, Christophi C, Weinberg L. Financial burden of postoperative complications following colonic resection: A systematic review. Medicine (Baltimore) 2021; 100:e26546. [PMID: 34232193 PMCID: PMC8270623 DOI: 10.1097/md.0000000000026546] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/09/2021] [Accepted: 06/14/2021] [Indexed: 01/04/2023] Open
Abstract
BACKGROUND Colonic resection is a common surgical procedure that is associated with a high rate of postoperative complications. Postoperative complications are expected to be major contributors to hospital costs. Therefore, this systematic review aims to outline the health costs of postoperative complications following colon resection surgery. METHODS MEDLINE, Excerpta Medica database, Cochrane, and Economics literature medical databases were searched from 2010 to 2019 to identify English studies containing an economic evaluation of postoperative complications following colonic resection in adult patients. All surgical techniques and indications for colon resection were included. Eligible study designs included randomized trials, comparative observational studies, and conference abstracts. RESULTS Thirty-four articles met the eligibility criteria. We found a high overall complication incidence with associated increased costs ranging from $2290 to $43,146. Surgical site infections and anastomotic leak were shown to be associated with greater resource utilization relative to other postoperative complications. Postoperative complications were associated with greater incidence of hospital readmission, which in turn is highlighted as a significant financial burden. Weak evidence demonstrates increased complication incidence and costlier complications with open colon surgery as compared to laparoscopic surgery. Notably, we identified a vast degree of heterogeneity in study design, complication reporting and costing methodology preventing quantitative analysis of cost results. CONCLUSIONS Postoperative complications in colonic resection appear to be associated with a significant financial burden. Therefore, large, prospective, cost-benefit clinical trials investigating preventative strategies, with detailed and consistent methodology and reporting standards, are required to improve patient outcomes and the cost-effectiveness of our health care systems.
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Affiliation(s)
- Maleck Louis
- Department of Anesthesia, Austin Health, Victoria, Australia
| | | | - Leonid Churilov
- Department of Medicine (Austin Health) & Melbourne Brain Centre at Royal Melbourne Hospital, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, Victoria, Australia
| | - Ronald Ma
- Department of Finance, Austin Health, Victoria, Australia
| | | | - Laurence Weinberg
- Department of Anesthesia, Austin Health, Heidelberg, Australia
- Department of Surgery, The University of Melbourne, Austin Health, Victoria, Australia
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Panaccione R. The Great Debate With IBD Biosimilars: Con: Biosimilars Should Not Be Routinely Used as a First Line Biologic and Not Switched From Reference Biologics. CROHN'S & COLITIS 360 2021; 3:otab038. [PMID: 36776671 PMCID: PMC9802193 DOI: 10.1093/crocol/otab038] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/14/2021] [Indexed: 12/25/2022] Open
Abstract
The costs associated with biologic therapy in immune-mediated diseases, including inflammatory bowel disease has steadily increased since their introduction over 2 decades ago. The introduction of biosimilars has the promise of cost savings and putting reimbursement pressure on future market entries. However, the interpretation of evidence to support the use of biosimilars either as first line or as part of a nonmedical switch strategy is not straight forward due to low to very low-quality evidence. In particular, switching to a biosimilar is associated with both clinical, ethical, and possibly medicolegal issues. Due to these factors, solutions to address cost efficiency should involve an open, transparent, and collaborative dialogue among the various stakeholders and if at all possible involve strategies that allow patients to remain on originator biologics.
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Affiliation(s)
- Remo Panaccione
- Inflammatory Bowel Disease Clinic, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
- Address correspondence to: Remo Panaccione, MD, FRCPC, 3280 Hospital Drive NW, Calgary, AB T2N 4Z6, Canada ()
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Rao J, Shao L, Lin M, Huang J, Fan L. LncRNA UCA1 Accelerates the Progression of Ulcerative Colitis via Mediating the miR-331-3p/BRD4 Axis. Int J Gen Med 2021; 14:2427-2435. [PMID: 34140798 PMCID: PMC8203302 DOI: 10.2147/ijgm.s304837] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2021] [Accepted: 04/06/2021] [Indexed: 12/30/2022] Open
Abstract
Background Ulcerative colitis (UC) has become one of the fastest-growing severe diseases worldwide with high morbidity. This research aimed to explore the function of lncRNA UCA1 in UC progression. Methods RT-qPCR analysis was used to examine the expression of UCA1 level in colonic mucosa tissues of UC patients. Then, fetal human cells (FHCs) were stimulated by LPS to induce inflammatory injury. CCK-8, flow cytometry and ELISA were adopted to determine the influence of UCA1 depletion on cell viability, apoptosis and pro-inflammatory factors levels in LPS-induced FHCs. The interaction between UCA1 and miR-331-3p or BRD4 was confirmed by luciferase reporter assay. The expressions of key factors involved in NF-κB pathway were assessed by Western blotting. Results LncRNA UCA1 level was elevated in colonic mucosa tissues of UC patients. LPS stimulation restrained cell viability and promoted the apoptosis and inflammatory factors levels, thus inducing FHCs inflammatory injury, while these effects were partially abolished by UCA1 knockdown. Moreover, it was found that UCA1 silence improved LPS-triggered cell injury via miR-331-3p. In addition, BRD4 was directly targeted by miR-331-3p, and BRD4 deficiency neutralized the effects of miR-331-3p repression on LPS-triggered injury in LPS-treated FHCs. Conclusion Our data determined that UCA1 knockdown attenuated UC development via targeting the miR-331-3p/BRD4/NF-κB pathway.
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Affiliation(s)
- Jun Rao
- Department of Gastroenterology, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, People's Republic of China
| | - Lihua Shao
- Department of Gastroenterology, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, People's Republic of China
| | - Min Lin
- Department of Gastroenterology, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, People's Republic of China
| | - Jin Huang
- Department of Gastroenterology, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, People's Republic of China
| | - Li Fan
- Department of Gastroenterology, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, People's Republic of China
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Olaiya B, Renelus BD, Filon M, Saha S. Trends in Morbidity and Mortality Following Colectomy Among Patients with Ulcerative Colitis in the Biologic Era (2002-2013): A Study Using the National Inpatient Sample. Dig Dis Sci 2021; 66:2032-2041. [PMID: 32676826 DOI: 10.1007/s10620-020-06474-1] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/08/2019] [Accepted: 07/04/2020] [Indexed: 12/11/2022]
Abstract
BACKGROUND Total abdominal colectomy (TAC) is a treatment modality of last recourse for patients with severe and/or refractory ulcerative colitis (UC). The goal of this study is to evaluate temporal trends and treatment outcomes following TAC among hospitalized UC patients in the biologic era. METHODS We queried the National Inpatient Sample (NIS) to identify patients older than 18 years with a primary diagnosis of ulcerative colitis (UC) who underwent TAC between 2002 and 2013. We evaluated postoperative morbidity and mortality as outcomes of interest. Logistic regression was used to explore factors associated with postoperative morbidity and mortality after TAC. RESULTS A weighted total of 307,799 UC hospitalizations were identified. Of these, 27,853 (9%) resulted in TAC. Between 2002 and 2013, hospitalizations for UC increased by over 70%; however, TAC rates dropped significantly from 111.1 to 77.1 colectomies per 1000 UC admissions. Overall, 2.2% of patients died after TAC. Mortality rates after TAC decreased from 3.5% in 2002 to 1.4% in 2013. Conversely, morbidity rates were stable throughout the study period. UC patients with emergent admissions, higher comorbidity scores and who had TAC in low volume colectomy hospitals had poorer outcomes. Regardless of admission type, outcomes were worse if TAC was performed more than 24 h after admission. CONCLUSIONS Despite increased hospitalizations for UC, rates of TAC have declined during the post-biologic era. For UC patients who undergo TAC, mortality has declined significantly while morbidity remains stable. Older age, race, emergent admissions and delayed surgery are predictive factors of both postoperative morbidity and mortality.
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Affiliation(s)
- Babatunde Olaiya
- Department of Internal Medicine, Marshfield Clinic, Marshfield, WI, USA.
| | - Benjamin D Renelus
- Department of Gastroenterology, Brooklyn Methodist, New York-Presbyterian Hospital, Brooklyn, NY, USA
| | - Mikolaj Filon
- School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA
| | - Sumona Saha
- Division of Gastroenterology and Hepatology, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA
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Systematic review and meta-analysis: risks of postoperative complications with preoperative use of anti-tumor necrosis factor-alpha biologics in inflammatory bowel disease patients. Eur J Gastroenterol Hepatol 2021; 33:799-816. [PMID: 33079779 DOI: 10.1097/meg.0000000000001944] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
OBJECTIVE The preoperative use of anti-tumor necrosis factor-alpha (anti-TNF) in inflammatory bowel disease (IBD) patients undergoing surgery has been controversial due to concern for increased risks of postoperative complications. We aimed to determine the effect of preoperative anti-TNF therapy on postoperative complications in IBD patients undergoing abdominal surgery. METHODS A literature search of Google Scholar, PubMed, The Cochrane Library, EMBASE, and CINAHL was performed through October 2019. Studies reporting postoperative complication rates of Crohn's disease (CD), ulcerative colitis (UC), and IBD-unspecified patients with preoperative anti-TNF treatment undergoing abdominal surgery compared to controls without preoperative anti-TNF treatment were included. The main outcomes measured were overall, infectious, and noninfectious postoperative complications. RESULTS Forty-one studies totaling 20 274 patients were included. There was a significant increase in overall complications in all patients treated with anti-TNF vs. controls [odds ratio (OR) = 1.13, 95% confidence interval (CI), 1.01-1.25, P = 0.03, I2 = 6%] with an absolute risk increase (ARI) of 5.5% and a number needed to harm (NNH) of 18. There was also a significant increase in infectious complications in CD patients (OR = 1.44; 95% CI 1.02-2.03, P = 0.04, I2 = 49%, ARI = 5.5%, NNH = 20) only. Contrastingly, there was a significant increase in noninfectious complications in all patients (OR = 1.44, 95% CI 1.13-1.85, P = 0.003, I2 = 8%, ARI = 6.4%, NNH = 16) and UC patients (OR = 1.57, 95% CI 1.15-2.14, P = 0.005, I2 = 25%, ARI = 8.5%, NNH = 12) only. CONCLUSION Preoperative use of anti-TNF agents in IBD patients undergoing abdominal surgery is associated with increases in overall postoperative complications in all patients, infectious postoperative complications in CD patients, and noninfectious postoperative complications in UC patients.
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Gandle C, Scott FI, Waljee A, Vajravelu RK, Sansgiry S, Hou JK. Development and Validation of an Administrative Codes Algorithm to Identify Abdominal Surgery and Bowel Obstruction in Patients With Inflammatory Bowel Disease. CROHN'S & COLITIS 360 2021; 3:otab010. [PMID: 36798959 PMCID: PMC9927823 DOI: 10.1093/crocol/otab010] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/15/2020] [Indexed: 12/22/2022] Open
Abstract
Background Validated administrative codes (CPT and ICD) can permit the use of large databases to study diseases and outcomes. The aim of this study was to validate administrative codes for surgery and obstructive complications in patients with inflammatory bowel disease (IBD). Methods We performed a retrospective study of IBD patients within the Veterans Affairs Health Administration (VA) from 2000 to 2015 with administrative codes for bowel surgery and complications validated by chart review. Positive predictive values (PPVs) and negative predictive value (NPV) were calculated. Results The PPV for bowel surgery was 96.4%; PPV of obstruction codes for bowel obstruction was 80.5% (95% confidence interval: 69.1%, 89.2%). Conclusions CPT and ICD codes for abdominal surgery and obstructive complications can be accurately utilized in IBD patients in VA.
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Affiliation(s)
- Cassandra Gandle
- Department of Medicine, Baylor College of Medicine, Houston, Texas, USA
| | - Frank I Scott
- Department of Medicine, Section of Gastroenterology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
| | - Akbar Waljee
- VA Center for Clinical Management Research, VA Ann Arbor Health Care System, Ann Arbor, Michigan, USA,Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Michigan, USA
| | - Ravy K Vajravelu
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Shubhada Sansgiry
- Veterans Affairs South Central Mental Illness Research Education and Clinical Center (MIRECC), Houston, Texas, USA,Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA,Department of Medicine, Section of Gastroenterology, Baylor College of Medicine, Houston, Texas, USA
| | - Jason K Hou
- Address correspondence to: Jason K. Hou, MD, MS, 7200 Cambridge Street, Houston, TX 77030, USA ()
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Ropelato RV, Kotze PG, Froehner Junior I, Dadan DD, Miranda EF. Postoperative mortality in inflammatory bowel disease patients. JOURNAL OF COLOPROCTOLOGY 2021. [DOI: 10.1016/j.jcol.2017.01.001] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/20/2023]
Abstract
Abstract
Introduction Since the 1960s, mortality in Crohn's disease and Ulcerative Colitis patients had a significant decrease due to advances in medical and surgical therapy. An important proportion of these patients are submitted to surgical procedures during their disease course, with postoperative mortality between 4 and 10%.
Methods 157 inflammatory bowel disease patients submitted to surgical therapy were retrospectively identified and allocated in 2 groups (Crohn's and colitis). Deaths were individually discriminated in detail.
Results 281 surgical procedures were performed. In the colitis group, 43 operations were performed in 24 patients; in the abdominal Crohn's subgroup, 127 procedures in 90 patients and in the perineal Crohn's subgroup, 115 in 64 patients, respectively. Nine postoperative deaths were observed (3 in the colitis and 6 in the Crohn's groups). Overall postoperative mortality was 5.7% (4.5% for Crohn's; 6.6% in abdominal Crohn's and 12.5% for Colitis). Most of deaths were related to emergency procedures and previous use of corticosteroids. The cause of death in all patients was sepsis.
Conclusions Overall postoperative mortality in inflammatory bowel disease was 5.7%, and it was attributed to the severity of the cases referred.
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Affiliation(s)
- Renato Vismara Ropelato
- Pontifícia Universidade Católica do Paraná (PUCPR), Hospital Universitário Cajuru (SeCoHUC), Unidade de Cirurgia Colorectal, Curitiba, PR, Brazil
| | - Paulo Gustavo Kotze
- Pontifícia Universidade Católica do Paraná (PUCPR), Hospital Universitário Cajuru (SeCoHUC), Unidade de Cirurgia Colorectal, Curitiba, PR, Brazil
| | - Ilário Froehner Junior
- Pontifícia Universidade Católica do Paraná (PUCPR), Hospital Universitário Cajuru (SeCoHUC), Unidade de Cirurgia Colorectal, Curitiba, PR, Brazil
| | - Danieli D. Dadan
- Pontifícia Universidade Católica do Paraná (PUCPR), Hospital Universitário Cajuru (SeCoHUC), Unidade de Cirurgia Colorectal, Curitiba, PR, Brazil
| | - Eron Fábio Miranda
- Pontifícia Universidade Católica do Paraná (PUCPR), Hospital Universitário Cajuru (SeCoHUC), Unidade de Cirurgia Colorectal, Curitiba, PR, Brazil
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Quaresma AB, Baraúna FDSB, Teixeira FV, Saad-Hossne R, Kotze PG. Exploring the Relationship between Biologics and Postoperative Surgical Morbidity in Ulcerative Colitis: A Review. J Clin Med 2021; 10:710. [PMID: 33670200 PMCID: PMC7916930 DOI: 10.3390/jcm10040710] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/30/2020] [Revised: 02/04/2021] [Accepted: 02/07/2021] [Indexed: 01/12/2023] Open
Abstract
BACKGROUND With the paradigm shift related to the overspread use of biological agents in the treatment of inflammatory bowel diseases (IBD), several questions emerged from the surgical perspective. Whether the use of biologicals would be associated with higher rates of postoperative complications in ulcerative colitis (UC) patients still remains controversial. AIMS We aimed to analyze the literature, searching for studies that correlated postoperative complications and preoperative exposure to biologics in UC patients, and synthesize these data qualitatively in order to check the possible impact of biologics on postoperative surgical morbidity in this population. METHODS Included studies were identified by electronic search in the PUBMED database according to the PRISMA (Preferred Items of Reports for Systematic Reviews and Meta-Analysis) guidelines. The quality and bias assessments were performed by MINORS (methodological index for non-randomized studies) criteria for non-randomized studies. RESULTS 608 studies were initially identified, 22 of which were selected for qualitative evaluation. From those, 19 studies (17 retrospective and two prospective) included preoperative anti-TNF. Seven described an increased risk of postoperative complications, and 12 showed no significant increase postoperative morbidity. Only three studies included surgical UC patients with previous use of vedolizumab, two retrospective and one prospective, all with no significant correlation between the drug and an increase in postoperative complication rates. CONCLUSIONS Despite conflicting results, most studies have not shown increased complication rates after abdominal surgical procedures in patients with UC with preoperative exposure to biologics. Further prospective studies are needed to better establish the impact of preoperative biologics and surgical complications in UC.
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Affiliation(s)
- Abel Botelho Quaresma
- Department of Colorectal Surgery, Universidade do Oeste de Santa Catarina (UNOESC), Joaçaba 89600-000, Brazil;
| | | | | | - Rogério Saad-Hossne
- Botucatu Medical School, Paulista State University (UNESP), Botucatu 18618-687, Brazil;
| | - Paulo Gustavo Kotze
- Colorectal Ssurgery Unit, Pontificia Universidade Católica do Paraná (PUCPR), Curitiba 80215-901, Brazil;
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Grazie ML, Bagnoli S, Dragoni G, Caini S, Annese V, Innocenti T, Deiana S, Manetti N, Milani S, Galli A, Milla M. Infliximab is more effective than cyclosporine as a rescue therapy for acute severe ulcerative colitis: a retrospective single-center study. Ann Gastroenterol 2021; 34:370-377. [PMID: 33948062 PMCID: PMC8079874 DOI: 10.20524/aog.2021.0584] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/29/2020] [Accepted: 11/02/2020] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Acute severe ulcerative colitis (ASUC) is a potentially life-threatening disease, and the best option in cases of steroid-refractory disease is still debated. We compared the early- and long-term efficacy and safety of the 2 available "rescue therapies", infliximab (IFX) and cyclosporine (CYS), in this setting. METHODS We retrospectively evaluated patients admitted for ASUC and treated with "rescue therapy". The primary endpoint was early colectomy-free survival (30 days) and colectomy-free survival until the end of follow up. The secondary endpoints were predictors of colectomy and long-term maintenance of the treatment strategy over time. RESULTS Of 129 patients admitted, 68 received rescue therapy (47 with IFX), whereas 7 underwent early colectomy (10.3%). At 30 days, fewer patients treated with IFX showed a need for colectomy (8.5% vs. 14.3%) compared to those in the CYS group, though the difference was non-significant (odds ratio [OR] 0.69, 95% confidence interval [CI] 0.10-4.69; P=0.47). No severe side effects due to IFX and CYS were observed. During a mean follow up of 40 months, 23 additional patients (37.7%) underwent colectomy, and the rate was significantly lower in the IFX group (25.6%) than in the CYS group (66.7%) (hazard ratio 0.25, 95%CI 0.10-0.61; P=0.003). Colectomy-free survival was significantly higher in the IFX group than in the CYS group (P=0.018) at 12 months. CONCLUSIONS In our setting, the early outcomes of IFX and CYS for ASUC were comparable. IFX was associated with significantly lower colectomy rates during the observation period and had a similar safety profile to CYS.
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Affiliation(s)
- Marco Le Grazie
- IBD Referral Center, Department of Gastroenterology, AOU Careggi Hospital, Florence, Italy (Marco Le Grazie, Siro Bagnoli, Gabriele Dragoni, Tommaso Innocenti, Stefano Milani, Andrea Galli, Monica Milla)
| | - Siro Bagnoli
- IBD Referral Center, Department of Gastroenterology, AOU Careggi Hospital, Florence, Italy (Marco Le Grazie, Siro Bagnoli, Gabriele Dragoni, Tommaso Innocenti, Stefano Milani, Andrea Galli, Monica Milla)
| | - Gabriele Dragoni
- IBD Referral Center, Department of Gastroenterology, AOU Careggi Hospital, Florence, Italy (Marco Le Grazie, Siro Bagnoli, Gabriele Dragoni, Tommaso Innocenti, Stefano Milani, Andrea Galli, Monica Milla)
- Gastroenterology Research Unit, Department of Experimental and Clinical Biochemical Sciences “Mario Serio”, University of Florence, Italy (Gabriele Dragoni, Stefano Milani, Andrea Galli)
| | - Saverio Caini
- C.S. Epidemiology of Risk Factors and Lifestyle, Institute for Oncologic Study, Prevention and Networking (ISPRO), Florence, Italy (Saverio Caini)
| | - Vito Annese
- Valiant Clinic, Dubai, United Arab Emirates (Vito Annese)
| | - Tommaso Innocenti
- IBD Referral Center, Department of Gastroenterology, AOU Careggi Hospital, Florence, Italy (Marco Le Grazie, Siro Bagnoli, Gabriele Dragoni, Tommaso Innocenti, Stefano Milani, Andrea Galli, Monica Milla)
| | - Simona Deiana
- Gastroenterology and Digestive Endoscopy, Ramazzini Hospital, Carpi – AUSL Modena, Modena, Italy (Simona Deiana)
| | - Natalia Manetti
- Gastroenterology and Digestive Endoscopy, San Jacopo Hospital, Pistoia, Usl Centro Toscana, Italy (Natalia Manetti)
| | - Stefano Milani
- IBD Referral Center, Department of Gastroenterology, AOU Careggi Hospital, Florence, Italy (Marco Le Grazie, Siro Bagnoli, Gabriele Dragoni, Tommaso Innocenti, Stefano Milani, Andrea Galli, Monica Milla)
- Gastroenterology Research Unit, Department of Experimental and Clinical Biochemical Sciences “Mario Serio”, University of Florence, Italy (Gabriele Dragoni, Stefano Milani, Andrea Galli)
| | - Andrea Galli
- IBD Referral Center, Department of Gastroenterology, AOU Careggi Hospital, Florence, Italy (Marco Le Grazie, Siro Bagnoli, Gabriele Dragoni, Tommaso Innocenti, Stefano Milani, Andrea Galli, Monica Milla)
- Gastroenterology Research Unit, Department of Experimental and Clinical Biochemical Sciences “Mario Serio”, University of Florence, Italy (Gabriele Dragoni, Stefano Milani, Andrea Galli)
| | - Monica Milla
- IBD Referral Center, Department of Gastroenterology, AOU Careggi Hospital, Florence, Italy (Marco Le Grazie, Siro Bagnoli, Gabriele Dragoni, Tommaso Innocenti, Stefano Milani, Andrea Galli, Monica Milla)
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Nakase H, Uchino M, Shinzaki S, Matsuura M, Matsuoka K, Kobayashi T, Saruta M, Hirai F, Hata K, Hiraoka S, Esaki M, Sugimoto K, Fuji T, Watanabe K, Nakamura S, Inoue N, Itoh T, Naganuma M, Hisamatsu T, Watanabe M, Miwa H, Enomoto N, Shimosegawa T, Koike K. Evidence-based clinical practice guidelines for inflammatory bowel disease 2020. J Gastroenterol 2021; 56:489-526. [PMID: 33885977 PMCID: PMC8137635 DOI: 10.1007/s00535-021-01784-1] [Citation(s) in RCA: 293] [Impact Index Per Article: 73.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/25/2021] [Accepted: 03/25/2021] [Indexed: 02/07/2023]
Abstract
Inflammatory bowel disease (IBD) is a general term for chronic or remitting/relapsing inflammatory diseases of the intestinal tract and generally refers to ulcerative colitis (UC) and Crohn's disease (CD). Since 1950, the number of patients with IBD in Japan has been increasing. The etiology of IBD remains unclear; however, recent research data indicate that the pathophysiology of IBD involves abnormalities in disease susceptibility genes, environmental factors and intestinal bacteria. The elucidation of the mechanism of IBD has facilitated therapeutic development. UC and CD display heterogeneity in inflammatory and symptomatic burden between patients and within individuals over time. Optimal management depends on the understanding and tailoring of evidence-based interventions by physicians. In 2020, seventeen IBD experts of the Japanese Society of Gastroenterology revised the previous guidelines for IBD management published in 2016. This English version was produced and modified based on the existing updated guidelines in Japanese. The Clinical Questions (CQs) of the previous guidelines were completely revised and categorized as follows: Background Questions (BQs), CQs, and Future Research Questions (FRQs). The guideline was composed of a total of 69 questions: 39 BQs, 15 CQs, and 15 FRQs. The overall quality of the evidence for each CQ was determined by assessing it with reference to the Grading of Recommendations Assessment, Development and Evaluation approach, and the strength of the recommendation was determined by the Delphi consensus process. Comprehensive up-to-date guidance for on-site physicians is provided regarding indications for proceeding with the diagnosis and treatment.
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Affiliation(s)
- Hiroshi Nakase
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan ,grid.263171.00000 0001 0691 0855Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, S-1, W-16, Chuoku, Sapporo, Hokkaido 060-8543 Japan
| | - Motoi Uchino
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Shinichiro Shinzaki
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Minoru Matsuura
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Katsuyoshi Matsuoka
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Taku Kobayashi
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Masayuki Saruta
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Fumihito Hirai
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Keisuke Hata
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Sakiko Hiraoka
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Motohiro Esaki
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Ken Sugimoto
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Toshimitsu Fuji
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Kenji Watanabe
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Shiro Nakamura
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Nagamu Inoue
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Toshiyuki Itoh
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Makoto Naganuma
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Tadakazu Hisamatsu
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Mamoru Watanabe
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Hiroto Miwa
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Nobuyuki Enomoto
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Tooru Shimosegawa
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
| | - Kazuhiko Koike
- Guidelines Committee for Creating and Evaluating the “Evidence-Based Clinical Practice Guidelines for Inflammatory Bowel Disease”, The Japanese Society of Gastroenterology, 6F Shimbashi i-MARK Building, 2-6-2 Shimbashi, Minato-ku, Tokyo, 105-0004 Japan
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Wu X, Liang TY, Wang Z, Chen G. The role of hyperbaric oxygen therapy in inflammatory bowel disease: a narrative review. Med Gas Res 2021; 11:66-71. [PMID: 33818446 PMCID: PMC8130665 DOI: 10.4103/2045-9912.311497] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
Inflammatory bowel disease is a group of chronic recurrent diseases in the digestive tract, including ulcerative colitis and Crohn's disease. Over the past few decades, the treatment of IBD has made great progress but there is still a lot of room for improvement. Hyperbaric oxygen therapy (HBOT) was defined as the therapeutic effect of inhaling 100% oxygen higher than one atmosphere and reported to be used in stroke, decompression sickness and wound healing. Since several authors reported the role of HBOT as an adjunct to conventional medical treatment in patients with refractory IBD, the relevant research has shown an increasing trend in recent years. Clinical and experimental studies have revealed that HBOT may exert its therapeutic effect by inhibiting inflammation and strengthening the antioxidant system, promoting the differentiation of colonic stem cells and recruiting cells involved in repair. The purpose of this review is to summarize the past clinical and experimental studies and to understand the impact of HBOT in the treatment of IBD more deeply. In addition, we also hope to provide some ideas for future clinical and research work.
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Affiliation(s)
- Xin Wu
- Department of Neurosurgery & Brain and Nerve Research Laboratory, the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Tian-Yu Liang
- Department of Neurosurgery & Brain and Nerve Research Laboratory, the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Zhong Wang
- Department of Neurosurgery & Brain and Nerve Research Laboratory, the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Gang Chen
- Department of Neurosurgery & Brain and Nerve Research Laboratory, the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
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44
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Lowe SC, Sauk JS, Limketkai BN, Kwaan MR. Declining Rates of Surgery for Inflammatory Bowel Disease in the Era of Biologic Therapy. J Gastrointest Surg 2021; 25:211-219. [PMID: 33140318 DOI: 10.1007/s11605-020-04832-y] [Citation(s) in RCA: 25] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/01/2020] [Accepted: 10/17/2020] [Indexed: 02/08/2023]
Abstract
BACKGROUND Medical therapy for inflammatory bowel disease (IBD) has markedly advanced since the introduction of biologic therapeutics, although surgery remains an important therapeutic strategy for both Crohn's disease (CD) and ulcerative colitis (UC). This study evaluated how rates of bowel resection surgery and post-operative mortality for IBD have changed over the last decade in the era of biologic therapies. METHODS The Nationwide Readmission Database (NRD) was queried for patients with IBD (based on ICD-9 and -10 diagnosis and procedure codes) who were hospitalized between 2010 and 2017. Longitudinal trends in bowel resection surgery, urgent surgery, and post-operative mortality were analyzed. RESULTS During the 8-year period, a total of 1795,266 IBD-related hospitalizations (1,072,110 with CD and 723,156 with UC) were evaluated. There was an increase in the annual number of IBD patients hospitalized, but a statistically significant decrease in the proportion of IBD patients undergoing surgery, from 10 to 8.8% (p < 0.001) for CD and 7.7 to 7.5% (p < 0.001) for UC. From 2014 through 2017, the proportion of urgent surgeries remained stable around 25% (p = 0.16) for CD and decreased from 21 to 14% (p < 0.001) for UC. For CD, the rate of post-operative 30-day mortality varied between 1.2 and 1.6% and for UC decreased from 5.8 to 2.3% (p < 0.001). CONCLUSIONS Analysis of a nationwide dataset from 2010 to 2017 determined that despite an increase in total admissions for IBD, a smaller proportion of hospitalized patients underwent surgery. A greater proportion of surgeries for UC were performed on an elective basis, and overall the rates of post-operative mortality for CD and UC decreased. The growth of biologic medical therapy during the study period highlights a probable contributing factor for the observed changes.
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Affiliation(s)
- Sarina C Lowe
- Department of Medicine, David Geffen School of Medicine at University of California Los Angeles, 757 Westwood Plaza, Los Angeles, CA, 90095, USA.
| | - Jenny S Sauk
- Center for Inflammatory Bowel Diseases, Vatche & Tamar Manoukian Division of Digestive Diseases, University of California Los Angeles, Los Angeles, CA, USA
| | - Berkeley N Limketkai
- Center for Inflammatory Bowel Diseases, Vatche & Tamar Manoukian Division of Digestive Diseases, University of California Los Angeles, Los Angeles, CA, USA
| | - Mary R Kwaan
- Department of Surgery, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA
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45
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Yu T, Meng F, Xie M, Liu H, Zhang L, Chen X. Long Noncoding RNA PMS2L2 Downregulates miR-24 through Methylation to Suppress Cell Apoptosis in Ulcerative Colitis. Dig Dis 2020; 39:467-476. [PMID: 33238281 DOI: 10.1159/000513330] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/12/2020] [Accepted: 11/23/2020] [Indexed: 02/02/2023]
Abstract
BACKGROUND Ulcerative colitis (UC) is an inflammatory bowel disease characterized by chronic inflammation of the colon. It has been reported that PMS2L2 plays protective roles in inflammatory injury. This study aimed to investigate the role of the long noncoding RNA PMS2L2 in UC. METHODS Sixty-two patients with UC as well as 62 age- and gender-matched healthy controls were enrolled. Expressions of PMS2L2 and miR-24 in plasma from UC patients and healthy controls were determined by RT-qPCR. The interaction between PMS2L2 and miR-24 was predicted by bioinformatics and confirmed by RNA immunoprecipitation and RNA pull-down. The role of PMS2L2 in the regulation of miR-24 gene methylation was analyzed by methylation-specific PCR. The effects of PMS2L2 and miR-24 on the expressions of apoptosis-related proteins were detected by Western blots. RESULTS PMS2L2 was downregulated in the plasma of UC patients compared to that in age- and gender-matched healthy control. In human colonic epithelial cells (HCnEpCs), PMS2L2 overexpression inhibited miR-24 expression via promoting the methylation of miR-24 gene. In contrast, miR-24 overexpression failed to affect PMS2L2. In the detection of cell apoptosis, PMS2L2 overexpression could promote the expression of Bcl-2 and inhibit Bax, cleaved-caspase-3, and cleaved-caspase-9 expressions stimulated by LPS. Flow cytometer revealed that PMS2L2 elevation suppressed the apoptosis of HCnEpCs induced by LPS, but miR-24 aggravated the apoptosis. PMS2L2 overexpression rescued the detrimental effect of miR-24 on cell apoptosis. CONCLUSION PMS2L2 may downregulate miR-24 via methylation to suppress cell apoptosis in UC.
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Affiliation(s)
- Ting Yu
- Department of TCM Proctlogy, Jinshan Hospital Affiliated to Fudan University, Shanghai, China
| | - Fanyu Meng
- Department of TCM Proctlogy, Jinshan Hospital Affiliated to Fudan University, Shanghai, China
| | - Minning Xie
- Department of TCM Proctlogy, Jinshan Hospital Affiliated to Fudan University, Shanghai, China
| | - Huajiang Liu
- Department of TCM Proctlogy, Jinshan Hospital Affiliated to Fudan University, Shanghai, China
| | - Lei Zhang
- Department of TCM Proctlogy, Jinshan Hospital Affiliated to Fudan University, Shanghai, China
| | - Xinghua Chen
- Department of TCM Proctlogy, Jinshan Hospital Affiliated to Fudan University, Shanghai, China
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46
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Solon JG, Oliva K, Farmer KC, Wang W, Wilkins S, McMurrick PJ. Rectum versus colon: should malignant polyps be treated differently? ANZ J Surg 2020; 91:927-931. [PMID: 33176067 DOI: 10.1111/ans.16437] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/04/2020] [Revised: 10/19/2020] [Accepted: 10/20/2020] [Indexed: 11/28/2022]
Abstract
BACKGROUND The management of malignant colorectal polyps removed at endoscopy remains controversial with patients either undergoing surgical resection or regular endoscopic surveillance. Lymph node (LN) metastases occur in 6-16% of patients with malignant polyps. This study assessed the rate of LN metastases in patients undergoing surgical resection for malignant polyps removed endoscopically to determine if there is a difference in the rate of LN metastases between colonic and rectal polyps. METHODS A retrospective review of a prospectively maintained database was performed from 2010 to 2018. All patients who underwent surgical resection following endoscopic removal of a malignant colorectal polyp were reviewed. Clinical data including patient demographics and tumour characteristics were examined. RESULTS A total of 177 patients underwent surgical resection in the study period. The median age at diagnosis was 65 years (range 22-88 years) with females comprising 52% of the patient cohort (n = 92/177). Polyps were located in the colon in 60.5% of cases with the remainder located in the rectum. The median number of LN harvested was 14 (range 0-44) with malignant LN (including a mesenteric tumour deposit) identified in 8.5% of resection specimens (n = 15/177). Malignant LNs were retrieved in 5.5% of right-sided tumours, 5.6% of left-sided tumours and 12.9% of rectal tumours (P = 0.090). CONCLUSION A small proportion of patients with malignant polyps removed endoscopically will have LN metastases. The results of this study suggest that the tumour location might be a useful predictive marker; however, a further study with increased patient numbers is required to properly establish this finding.
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Affiliation(s)
- J Gemma Solon
- Cabrini Monash University Department of Surgery, Cabrini Hospital, Melbourne, Victoria, Australia
| | - Karen Oliva
- Cabrini Monash University Department of Surgery, Cabrini Hospital, Melbourne, Victoria, Australia
| | - K Chip Farmer
- Cabrini Monash University Department of Surgery, Cabrini Hospital, Melbourne, Victoria, Australia
| | - Wei Wang
- Cabrini Institute, Cabrini Hospital, Melbourne, Victoria, Australia.,Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
| | - Simon Wilkins
- Cabrini Monash University Department of Surgery, Cabrini Hospital, Melbourne, Victoria, Australia.,Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
| | - Paul J McMurrick
- Cabrini Monash University Department of Surgery, Cabrini Hospital, Melbourne, Victoria, Australia
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Law CC, Bell C, Koh D, Bao Y, Jairath V, Narula N. Risk of postoperative infectious complications from medical therapies in inflammatory bowel disease. Cochrane Database Syst Rev 2020; 10:CD013256. [PMID: 33098570 PMCID: PMC8094278 DOI: 10.1002/14651858.cd013256.pub2] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND Medications used to treat inflammatory bowel disease (IBD) have significantly improved patient outcomes and delayed time to surgery. However, some of these therapies are recognized to increase the general risk of infection and have an unclear impact on postoperative infection risk. OBJECTIVES To assess the impact of perioperative IBD medications on the risk of postoperative infections within 30 days of surgery. SEARCH METHODS We searched the Cochrane IBD Group's Specialized Register (29 October 2019), MEDLINE (January 1966 to October 2019), Embase (January 1985 to October 2019), the Cochrane Library, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform from inception up to October 2019, and reference lists of articles. SELECTION CRITERIA Randomized controlled trials, quasi-randomized controlled trials, non-randomized controlled trials, prospective cohort studies, retrospective cohort studies, case-control studies and cross-sectional studies comparing participants treated with an IBD medication preoperatively or within 30 days postoperatively to those who were not taking that medication (either another active medication, placebo, or no treatment). We included published study reports and abstracts. DATA COLLECTION AND ANALYSIS Two review authors independently screened titles and abstracts and extracted data. The primary outcome was postoperative infection within 30 days of surgery. Secondary outcomes included incisional infections and wound dehiscence, intra-abdominal infectious complications and extra-abdominal infections. Three review authors assessed risks of bias using the Newcastle-Ottawa Scale. We contacted authors for additional information when data were missing. For the primary and secondary outcomes, we calculated odds ratios (ORs) and corresponding 95% confidence intervals (95% CIs) using the generic inverse variance method. When applicable, we analyzed adjusted and unadjusted data separately. We evaluated the certainty of the evidence using GRADE. MAIN RESULTS We included 68 observational cohort studies (total number of participants unknown because some studies did not report the number of participants). Of these, 48 studies reported including participants with Crohn's disease, 36 reported including participants with ulcerative colitis and five reported including participants with indeterminate colitis. All 42 studies that reported urgency of surgery included elective surgeries, with 31 (74%) of those also including emergency surgeries. Twenty-four studies had low risk of bias while the rest had very high risk. Based on pooling of adjusted data, we calculated ORs for postoperative total infection rates in participants who received corticosteroids (OR 1.70, 95% CI 1.38 to 2.09; low-certainty evidence), immunomodulators (OR 1.29, 95% CI 0.95 to 1.76; low-certainty evidence), anti-TNF agents (OR 1.60, 95% CI 1.20 to 2.13; very low-certainty evidence) and anti-integrin agents (OR 1.04, 95% CI 0.79 to 1.36; low-certainty evidence). We pooled unadjusted data to assess postoperative total infection rates for the use of aminosalicylates (5-ASA) (OR 0.76, 95% CI 0.51 to 1.14; very low-certainty evidence). One secondary outcome examined was wound-related complications in participants using: corticosteroids (OR 1.41, 95% CI 0.72 to 2.74; very low-certainty evidence), immunomodulators (OR 1.35, 95% CI 0.96 to 1.89; very low-certainty evidence), anti-TNF agents (OR 1.18, 95% CI 0.83 to 1.68; very low-certainty evidence) and anti-integrin agents (OR 1.64, 95% CI 0.77 to 3.50; very low-certainty evidence) compared to controls. Another secondary outcome examined the odds of postoperative intra-abdominal infections in participants using: corticosteroids (OR 1.53, 95% CI 1.28 to 1.84; very low-certainty evidence), 5-ASA (OR 0.77, 95% CI 0.45 to 1.33; very low-certainty evidence), immunomodulators (OR 0.86, 95% CI 0.66 to 1.12; very low-certainty evidence), anti-TNF agents (OR 1.38, 95% CI 1.04 to 1.82; very low-certainty evidence) and anti-integrin agents (OR 0.40, 95% CI 0.14 to 1.20; very low-certainty evidence) compared to controls. Lastly we checked the odds for extra-abdominal infections in participants using: corticosteroids (OR 1.23, 95% CI 0.97 to 1.55; very low-certainty evidence), immunomodulators (OR 1.17, 95% CI 0.80 to 1.71; very low-certainty evidence), anti-TNF agents (OR 1.34, 95% CI 0.96 to 1.87; very low-certainty evidence) and anti-integrin agents (OR 1.15, 95% CI 0.43 to 3.08; very low-certainty evidence) compared to controls. AUTHORS' CONCLUSIONS The evidence for corticosteroids, 5-ASA, immunomodulators, anti-TNF medications and anti-integrin medications was of low or very low certainty. The impact of these medications on postoperative infectious complications is uncertain and we can draw no firm conclusions about their safety in the perioperative period. Decisions on preoperative IBD medications should be tailored to each person's unique circumstances. Future studies should focus on controlling for potential confounding factors to generate higher-quality evidence.
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Affiliation(s)
- Cindy Cy Law
- Department of Medicine, McMaster University, Hamilton, Canada
| | - Conor Bell
- Department of Medicine, McMaster University, Hamilton, Canada
| | - Deborah Koh
- Department of Medicine, McMaster University, Hamilton, Canada
| | - Yueyang Bao
- Department of Biology, McMaster University, Hamilton, Canada
| | - Vipul Jairath
- Department of Medicine, University of Western Ontario, London, Canada
| | - Neeraj Narula
- Division of Gastroenterology, McMaster University, Hamilton, Canada
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Kaplan GG, Ma C, Seow CH, Kroeker KI, Panaccione R. The Argument Against a Biosimilar Switch Policy for Infliximab in Patients with Inflammatory Bowel Disease Living in Alberta. J Can Assoc Gastroenterol 2020; 3:234-242. [PMID: 32905124 PMCID: PMC7465546 DOI: 10.1093/jcag/gwz044] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/30/2019] [Accepted: 12/16/2019] [Indexed: 12/11/2022] Open
Abstract
A nonmedical switch policy is currently being considered in Alberta, which would force patients on originator biologics to biosimilar alternatives with the hypothetical aim of reducing costs to the health care system. The evidence to support the safety of nonmedical switching in patients with inflammatory bowel disease (IBD) is of low to very low quality; in fact, existing data suggest a potential risk of harm. In a pooled analysis of randomized controlled trials, one patient would lose response to infliximab for every 11 patients undergoing nonmedical switching. Switching to a biosimilar has important logistical and ethical implications including potential forced treatment changes without appropriate patient consent and unfairly penalizing patients living in rural areas and those without private drug insurance. Even in the best-case scenario, assuming perfectly executed switching without logistical delays, we predict switching 2,000 patients with Remicade will lead to over 60 avoidable surgeries in Alberta. Furthermore, nonmedical switching has not been adequately studied in vulnerable populations such as children, pregnant women, and elderly patients. While the crux of the argument for nonmedical switching is cost savings, biosimilar switching may not be cost effective: Particularly when originator therapies are being offered at the same price as biosimilars. Canadian patients with IBD have been surveyed, and their response is clear: They are not in support of nonmedical switching. Policies that directly influence patient health need to consider patient perspectives. Solutions to improve cost efficiency in health care exist but open, transparent collaboration between all involved stakeholders is required.
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Affiliation(s)
- Gilaad G Kaplan
- Inflammatory Bowel Disease Clinic, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Christopher Ma
- Inflammatory Bowel Disease Clinic, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Cynthia H Seow
- Inflammatory Bowel Disease Clinic, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Karen I Kroeker
- Inflammatory Bowel Disease Clinic, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
| | - Remo Panaccione
- Inflammatory Bowel Disease Clinic, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
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49
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Brookes MJ, Waller J, Cappelleri JC, Modesto I, DiBonaventura MD, Bohm N, Mokgokong R, Massey O, Wood R, Bargo D. Living with Ulcerative Colitis Study (LUCY) in England: a retrospective study evaluating healthcare resource utilisation and direct healthcare costs of postoperative care in ulcerative colitis. BMJ Open Gastroenterol 2020; 7:bmjgast-2020-000456. [PMID: 32938582 PMCID: PMC7497134 DOI: 10.1136/bmjgast-2020-000456] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/29/2020] [Revised: 07/15/2020] [Accepted: 07/17/2020] [Indexed: 12/30/2022] Open
Abstract
Objective Ulcerative colitis (UC) is a lifelong, relapsing-remitting disease. Patients non-responsive to pharmacological treatment may require a colectomy. We estimated pre-colectomy and post-colectomy healthcare resource utilisation (HCRU) and costs in England. Design/Method A retrospective, longitudinal cohort study indexing adult patients with UC undergoing colectomy (2009–2015), using linked Clinical Practice Research Datalink/Hospital Episode Statistics data, was conducted. HCRU, healthcare costs and pharmacological treatments were evaluated during 12 months prior to and including colectomy (baseline) and 24 months post-colectomy (follow-up; F-U), comparing baseline/F-U, emergency/elective colectomy and subtotal/full colectomy using descriptive statistics and paired/unpaired tests. Results 249 patients from 26 165 identified were analysed including 145 (58%) elective and 184 (74%) full colectomies. Number/cost of general practitioner consultations increased post-colectomy (p<0.001), and then decreased at 13–24 months (p<0.05). From baseline to F-U, the number of outpatient visits, number/cost of hospitalisations and total direct healthcare costs decreased (all p<0.01). Postoperative HCRU was similar between elective and emergency colectomies, except for the costs of colectomy-related hospitalisations and medication, which were lower in the elective group (p<0.05). Postoperative costs were higher for subtotal versus full colectomies (p<0.001). At 1–12 month F-U, 30%, 19% and 5% of patients received aminosalicylates, steroids and immunosuppressants, respectively. Conclusion HCRU/costs increased for primary care in the first year post-colectomy but decreased for secondary care, and varied according to the colectomy type. Ongoing and potentially unnecessary pharmacological therapy was seen in up to 30% of patients. These findings can inform patients and decision-makers of potential benefits and burdens of colectomy in UC.
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Affiliation(s)
- Matthew J Brookes
- Gastroenterology Department, Royal Wolverhampton NHS Trust, Wolverhampton, UK.,Research Institute in Healthcare Science, Faculty of Science and Engineering, University of Wolverhampton, Wolverhampton, UK
| | | | | | - Irene Modesto
- Inflammation & Immunology, Pfizer Inc, New York, New York, USA
| | | | | | | | | | | | - Danielle Bargo
- Patient Health Impact, Pfizer Inc, New York, New York, USA
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50
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Faye AS, Oh A, Kumble LD, Kiran RP, Wen T, Lawlor G, Lichtiger S, Abreu MT, Hur C. Fertility Impact of Initial Operation Type for Female Ulcerative Colitis Patients. Inflamm Bowel Dis 2020; 26:1368-1376. [PMID: 31880776 PMCID: PMC7534416 DOI: 10.1093/ibd/izz307] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2019] [Indexed: 02/07/2023]
Abstract
BACKGROUND Ileal pouch-anal anastomosis (IPAA) is the mainstay of surgical treatment for patients with ulcerative colitis (UC) but is associated with an increased risk of infertility. We developed a simulation model examining the impact of initial surgical procedure on quality-adjusted life-years (QALYs) and fertility end points. METHODS A patient-level state transition model was used to analyze outcomes by surgical approach strategy for females of childbearing age. Initial surgical options included IPAA, rectal-sparing colectomy with end ileostomy (RCEI), and ileorectal anastomosis (IRA). The primary outcome examined was QALYs, whereas secondary outcomes included UC and fertility-associated end points. RESULTS IPAA resulted in higher QALYs for patients aged 20-30 years, as compared with RCEI. For patients aged 35 years, RCEI resulted in higher QALYs (7.54 RCEI vs 7.53 IPAA) and was associated with a 28% higher rate of childbirth, a 14-month decrease in time to childbirth, and a 77% reduction in in vitro fertilization utilization. When accounting for the decreased infertility risk associated with laparoscopic IPAA, IPAA resulted in higher QALYs (7.57) even for patients aged 35 years. CONCLUSIONS Despite an increased risk of infertility, our model results suggest that IPAA may be the optimal surgical strategy for female UC patients aged 20-30 years who desire children. For patients aged 35 years, RCEI should additionally be considered, as QALYs for RCEI and IPAA were similar. These quantitative data can be used by patients and providers to help develop an individualized approach to surgical management choice.
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Affiliation(s)
- Adam S Faye
- Division of Digestive and Liver Diseases, Department of Medicine, New York, New York, USA
| | - Aaron Oh
- Division of Digestive and Liver Diseases, Department of Medicine, New York, New York, USA
| | - Lindsay D Kumble
- Division of Digestive and Liver Diseases, Department of Medicine, New York, New York, USA
| | - Ravi P Kiran
- Department of Colorectal Surgery, New York, New York, USA
| | - Timothy Wen
- Department of Obstetrics and Gynecology, New York Presbyterian Columbia University Medical Center, New York, New York, USA
| | - Garrett Lawlor
- Division of Digestive and Liver Diseases, Department of Medicine, New York, New York, USA
| | - Simon Lichtiger
- Division of Digestive and Liver Diseases, Department of Medicine, New York, New York, USA
| | - Maria T Abreu
- Division of Gastroenterology, Department of Medicine, University of Miami, Miami, Florida, USA
| | - Chin Hur
- Division of Digestive and Liver Diseases, Department of Medicine, New York, New York, USA
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