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Chan DKH, Siew BE, Lau J, Koh J, Lee MXH, Ang C, Pang NQ, Tan KK. Time to return of bowel function following perioperative probiotics in colorectal cancer surgery (PICCS-1): study protocol for a randomized controlled trial. Trials 2025; 26:60. [PMID: 39972354 PMCID: PMC11837682 DOI: 10.1186/s13063-025-08773-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/06/2024] [Accepted: 02/11/2025] [Indexed: 02/21/2025] Open
Abstract
BACKGROUND Postoperative ileus occurs in up to 30% of patients following major oncologic surgery for colorectal cancer, leading to significant morbidity, patient distress, as well as increased utilization of healthcare resources. Various modalities to reduce postoperative ileus rates have been explored. One such modality is the perioperative administration of probiotics which have hitherto achieved inconsistent success. Here, we design a trial to determine whether the perioperative administration with probiotics given together with nutritional supplementation can help to reduce postoperative ileus rates. METHODS We propose a parallel three-arm randomized controlled trial. In Arm 1, no nutritional supplementation is provided to the patient. In Arm 2, Nestle Isocal is provided to the participant. Nestle Isocal provides nutritional supplementation but without any probiotic. In Arm 3, Nestle Boost Optimum is provided to the patient. Nestle Boost Optimum contains a similar nutritional profile to Isocal, but with the addition of Lactobacillus paracasei. The primary outcome is the time to first bowel movement in days from the day of surgery. Secondary outcomes are time to first flatus, infective complications, and adverse events related to the administration of nutritional supplementation. Statistical analysis will be conducted in an intention-to-treat approach. ANOVA with the Tukey test will be used to compare continuous variables, while the χ2 test will be used for categorical variables. DISCUSSION Nutritional supplementation with probiotics is a convenient, non-pill alternative for patients. Furthermore, the interventions are commonly found in the formulary of many hospitals worldwide. If successful, probiotics in nutritional supplementation could be a cost-effective and simple way to reduce postoperative ileus. TRIAL REGISTRATION ClinicalTrials.gov NCT06456229. This trial was registered on 11 June 2024. Thai Clinical Trials Registry TCTR20240706003. This trial was registered on 6 July 2024.
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Affiliation(s)
- Dedrick Kok Hong Chan
- Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
- Division of Colorectal Surgery, University Surgical Cluster, National University Hospital, Singapore, Singapore.
| | - Bei En Siew
- Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Jerrald Lau
- Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Jasmin Koh
- Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Megan Xin-Hui Lee
- Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Chermaine Ang
- Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Ning Qi Pang
- Division of Hepatobiliary Surgery, University Surgical Cluster, National University Hospital, Singapore, Singapore
| | - Ker-Kan Tan
- Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
- Division of Colorectal Surgery, University Surgical Cluster, National University Hospital, Singapore, Singapore
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Paterson H, Vadiveloo T, Innes K, Balfour A, Atter M, Stoddart A, Cotton S, Arnott R, Aucott L, Batham Z, Foo I, MacLennan G, Nimmo S, Speake D, Norrie J. Intravenous Lidocaine for Gut Function Recovery in Colonic Surgery: A Randomized Clinical Trial. JAMA 2025; 333:39-48. [PMID: 39602290 PMCID: PMC11603374 DOI: 10.1001/jama.2024.23898] [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: 06/11/2024] [Accepted: 10/24/2024] [Indexed: 11/29/2024]
Abstract
Importance Despite the recovery advantages of minimally invasive surgical techniques, delayed return of gut function after colectomy is a common barrier to timely discharge from hospital. Objective To evaluate the effect of 2% perioperative intravenous lidocaine infusion on return of gut function after elective minimally invasive colon resection. Design, Setting, and Participants The ALLEGRO trial was a randomized, placebo-controlled, double-blind trial conducted in 27 UK hospitals. A total of 590 adults scheduled for elective minimally invasive colon resection for benign or malignant disease were randomized 1:1 to 2% intravenous lidocaine or saline placebo. Enrollment occurred from August 13, 2018, to April 11, 2023, with a pause in recruitment from March 20, 2020, through July 6, 2020; final follow-up was on August 10, 2023. Interventions The intervention patients received 2% intravenous lidocaine administered as 1.5-mg/kg bolus at induction of anesthesia followed by 1.5 mg/kg/h for 6 or 12 hours. Control patients received 0.9% saline placebo for 6 or 12 hours. Main Outcomes and Measures The primary outcome was the proportion of patients with return of gut function at 72 hours after surgery, defined by the GI-3 composite end point of tolerating diet (ingestion of food and drink without significant nausea or vomiting for 3 consecutive meals) and passage of flatus or stool. There were 11 secondary outcomes, including time to GI-3 recovery, time to GI-2 recovery (tolerance of oral diet and passage of stool), prolonged postoperative ileus, postoperative nausea and vomiting score, Overall Benefit of Analgesia Score, postoperative opioid consumption, Quality of Recovery-15, quality of life (EuroQol 5-Dimension 5-Level), enhanced recovery protocol adherence, time to meeting medically defined criteria for discharge, and time to patient self-assessed readiness for discharge. Results The trial enrolled 590 patients (295 intervention, 295 control); after 33 postrandomization exclusions, 557 patients were included (279 intervention, 278 control; 249 female patients [44.7%]; mean [SD] age, 66 [10.9] years); 532 (96%) received the randomized treatment. Return of gut function as defined by the GI-3 composite outcome was achieved at 72 hours by 160 patients (57.3%) in the intravenous lidocaine group vs 164 patients (59.0%) in the placebo group (adjusted absolute difference, -1.9% [95% CI, -8.0% to 4.2%]; relative risk, 0.97 [95% CI, 0.88 to 1.07]). There was no significant difference between the intervention and control groups in any of the 11 secondary end points. Conclusions and Relevance Among patients undergoing elective minimally invasive colon resection, perioperative administration of 2% intravenous lidocaine did not improve return of gut function at 72 hours. Trial Registration isrctn.org Identifier: ISRCTN52352431.
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Affiliation(s)
- Hugh Paterson
- University of Edinburgh, Edinburgh, United Kingdom
- Western General Hospital, Edinburgh, United Kingdom
| | - Thenmalar Vadiveloo
- Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom
| | - Karen Innes
- Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, United Kingdom
| | - Angie Balfour
- Western General Hospital, Edinburgh, United Kingdom
- Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom
| | - Marek Atter
- Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom
- Usher Institute, University of Edinburgh, Edinburgh, United Kingdom
| | - Andrew Stoddart
- Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom
- Usher Institute, University of Edinburgh, Edinburgh, United Kingdom
| | - Seonaidh Cotton
- Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, United Kingdom
| | - Robert Arnott
- Association of Coloproctology of Great Britain and Ireland, London, United Kingdom
| | - Lorna Aucott
- Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom
| | - Zoe Batham
- Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, United Kingdom
| | - Irwin Foo
- Western General Hospital, Edinburgh, United Kingdom
| | - Graeme MacLennan
- Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, United Kingdom
| | - Susan Nimmo
- Western General Hospital, Edinburgh, United Kingdom
| | - Doug Speake
- Western General Hospital, Edinburgh, United Kingdom
| | - John Norrie
- Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, United Kingdom
- Usher Institute, University of Edinburgh, Edinburgh, United Kingdom
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Emile SH, Horesh N, Garoufalia Z, Gefen R, Zhou P, Dasilva G, Wexner SD. Predictors and Impact of Ileus on Outcomes After Laparoscopic Right Colectomy: A Case-Control Study. Am Surg 2024; 90:3054-3060. [PMID: 38900811 DOI: 10.1177/00031348241260275] [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: 06/22/2024]
Abstract
BACKGROUND Ileus is a common complication of major abdominal surgery, including colorectal resection. The present study aimed to assess the predictors of ileus after laparoscopic right colectomy for colon cancer. METHODS This study was a retrospective case-control analysis of a prospective IRB-approved database of patients who underwent laparoscopic right colectomy at the Department of Colorectal Surgery, Cleveland Clinic Florida. Patients who developed ileus after right colectomy were compared to patients without ileus to determine the risk factors of ileus. RESULTS The present study included 270 patients with a mean age of 68.7 years. Thirty-six patients (13.3%) experienced ileus after laparoscopic right colectomy. The median duration of ileus was 6 days. Factors associated with ileus were age (71.6 vs 68.2 years, P = .158), emergency colectomy (11.1% vs 3.9%, P = .082), extended hemicolectomy (19.4% vs 6.8%, P = .021), green gastrointestinal anastomosis (GIA) 4.8mm staple height cartridge (19% vs 8.1%, P = .114), and longer operative time (177.9 vs 160.4 minutes, P = .157). The only independent predictor of ileus was extended colectomy (OR: 16.7, P = .003). CONCLUSIONS Increased age, emergency surgery, green GIA cartridge, and longer operative times were associated with ileus, yet the only independent predictor of ileus was extended right hemicolectomy.
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Affiliation(s)
- Sameh Hany Emile
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL, USA
- Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura, Egypt
| | - Nir Horesh
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL, USA
- Department of Surgery and Transplantation, Sheba Medical Center, Ramat-Gan, Israel
| | - Zoe Garoufalia
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL, USA
| | - Rachel Gefen
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL, USA
- Department of General Surgery, Hadassah Medical Organization and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel
| | - Peige Zhou
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL, USA
- Georgia Colon and Rectal Surgical Associates, Northside Hospital, Atlanta, GA, USA
| | - Giovanna Dasilva
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL, USA
| | - Steven D Wexner
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL, USA
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Zhou Y, Yin ZH, Sun MS, Wang YY, Yang C, Li SH, Liang FR, Liu F. Global research trends in postoperative ileus from 2011 to 2023: A scientometric study. World J Gastrointest Surg 2024; 16:3020-3031. [PMID: 39351552 PMCID: PMC11438810 DOI: 10.4240/wjgs.v16.i9.3020] [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: 06/09/2024] [Revised: 08/13/2024] [Accepted: 08/22/2024] [Indexed: 09/18/2024] Open
Abstract
BACKGROUND Postoperative ileus (POI) is a common complication after abdominal surgery with high morbidity, which hinders patient recovery, prolongs hospitalization, and increases healthcare costs. Therefore, POI has become a global public health challenge. POI triggering is multifactorial. Autonomic and hormonal mechanisms are generally involved in POI pathogenesis. Recent studies have shown that beta adrenergic signaling of enteric glia is a POI trigger. Currently, the status quo, trends, and frontiers of global research on POI remain unclear. AIM To explore the current status, trends, and frontiers of POI research from 2011 to the present based on bibliometric analysis. METHODS Publications published on POI research from 2011 to 2023 were retrieved on June 1, 2023, from the Web of Science Core Collection. CiteSpace 6.2.R2 and VOSviewer were used to conduct bibliometric visualization. RESULTS In total, 778 POI records published from 2011 to 2023 were retrieved. Over the past few decades, the annual cumulative number of related articles has linearly increased, with China and the United States of America contributing prominently. All publications were from 59 countries and territories. China and the University of Bonn were the top contributing country and institution, respectively. Neurogastroenterology & Motility was the most prolific journal. The Journal of Gastrointestinal Surgery had the highest number of citations. Wehner Sven was the most productive author. Burst keywords (e.g., colon, prolonged ileus, acupuncture, paralytic ileus, pathophysiology, rectal cancer, gastrointestinal function, risk) and a series of reference citation bursts provided evidence for the research frontiers in recent years. CONCLUSION This study demonstrates trends in the published literature on POI and provides new insights for researchers. It emphasizes the importance of multidisciplinary cooperation in the development of this field.
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Affiliation(s)
- Yan Zhou
- Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China
| | - Zi-Han Yin
- Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China
| | - Ming-Sheng Sun
- Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China
| | - Yang-Yang Wang
- Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China
| | - Chen Yang
- Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China
| | - Shu-Hao Li
- Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China
| | - Fan-Rong Liang
- Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China
| | - Fang Liu
- Department of Integrated Chinese and Western Medicine, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu 610041, Sichuan Province, China
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Ho JCE, Goel AR, Fung AH, Shaikh I, Iqbal MR. Robotic ambulatory colorectal resections: a systematic review. J Robot Surg 2024; 18:202. [PMID: 38713324 PMCID: PMC11076342 DOI: 10.1007/s11701-024-01961-3] [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: 04/09/2024] [Accepted: 04/21/2024] [Indexed: 05/08/2024]
Abstract
Colorectal surgery has progressed greatly via minimally invasive techniques, laparoscopic and robotic. With the advent of ERAS protocols, patient recovery times have greatly shortened, allowing for same day discharges (SDD). Although SDD have been explored through laparoscopic colectomy reviews, no reviews surrounding robotic ambulatory colorectal resections (RACrR) exist to date. A systematic search was carried out across three databases and internet searches. Data were selected and extracted by two independent reviewers. Inclusion criteria included robotic colorectal resections with a length of hospital stay of less than one day or 24 h. 4 studies comprising 136 patients were retrieved. 56% of patients were female and were aged between 21 and 89 years. Main surgery indications were colorectal cancer and recurrent sigmoid diverticulitis (43% each). Most patients had low anterior resections (48%). Overall, there was a 4% complication rate postoperatively, with only 1 patient requiring readmission due to postoperative urinary retention (< 1%). Patient selection criteria involved ASA score cut-offs, nutritional status, and specific health conditions. Protocols employed shared similarities including ERAS education, transabdominal plane blocks, early removal of urinary catheters, an opioid-sparing regime, and encouraged early oral intake and ambulation prior to discharge. All 4 studies had various follow-up methods involving telemedicine, face-to-face consultations, and virtual ward teams. RACrRs is safe and feasible in a highly specific patient population; however, further high-quality studies with larger sample sizes are needed to draw more significant conclusions. Several limitations included small sample size and the potential of recall bias due to retrospective nature of 2 studies.
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Affiliation(s)
| | - Aryan Raj Goel
- UCL Medical School, Faculty of Medical Sciences, London, UK
| | - Adriel Heilong Fung
- Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK
- University of East Anglia, Norwich, UK
| | - Irshad Shaikh
- Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK
- University of East Anglia, Norwich, UK
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Emile SH, Horesh N, Garoufalia Z, Gefen R, Ray-Offor E, Wexner SD. Strategies to reduce ileus after colorectal surgery: A qualitative umbrella review of the collective evidence. Surgery 2024; 175:280-288. [PMID: 38042712 DOI: 10.1016/j.surg.2023.10.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/16/2023] [Revised: 09/26/2023] [Accepted: 10/25/2023] [Indexed: 12/04/2023]
Abstract
BACKGROUND Various strategies were proposed to reduce postoperative ileus after colorectal surgery. This umbrella review aimed to provide a comprehensive overview of current evidence on measures to reduce the incidence and severity of postoperative ileus after colorectal surgery. METHODS A Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant systematic search was conducted in PubMed and Scopus to identify systematic reviews that assessed the efficacy of interventions used to prevent postoperative ileus after colorectal surgery. Data on study characteristics, interventions, and outcomes were summarized in a narrative manner. RESULTS A total of 26 systematic reviews incorporating various strategies like early oral feeding, gum chewing, coffee consumption, medications, and acupuncture were included. Early oral feeding reduced postoperative ileus and accelerated bowel function return. The most assessed intervention was chewing gum, which was associated with a median reduction of postoperative ileus by 45% (range, 11%-59%) and shortening of the time to first flatus and time to defecation by a median of 11.9 and 17.7 hours, respectively. Coffee intake showed inconsistent results, with a median shortening of time to flatus and time to defecation by 1.32 and 14.45 hours, respectively. CONCLUSION Early oral feeding, chewing gum, and alvimopan were the most commonly assessed and effective strategies for reducing postoperative ileus after colorectal surgery. Medications used to reduce postoperative ileus included alvimopan, intravenous lidocaine, dexamethasone, probiotics, and oral antibiotics. Intravenous dexamethasone and lidocaine and oral probiotics helped hasten bowel function return. Acupuncture positively impacted the recovery of bowel function.
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Affiliation(s)
- Sameh Hany Emile
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL; Colorectal Surgery Unit, General Surgery Department, Mansoura University Hospitals, Mansoura, Egypt. https://twitter.com/dr_samehhany81
| | - Nir Horesh
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL; Department of Surgery and Transplantation, Sheba Medical Center, Ramat-Gan, Israel. https://twitter.com/nirhoresh
| | - Zoe Garoufalia
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL. https://twitter.com/ZGaroufalia
| | - Rachel Gefen
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL; Department of General Surgery, Faculty of Medicine, Hadassah Medical Organization, Hebrew University of Jerusalem, Israel. https://twitter.com/RachellGefen
| | - Emeka Ray-Offor
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL; Department of Surgery, University of Port Harcourt, Choba, Rivers State, Nigeria
| | - Steven D Wexner
- Ellen Leifer Shulman and Steven Shulman Digestive Disease Center, Cleveland Clinic Florida, Weston, FL.
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Irani JL, Hedrick TL, Miller TE, Lee L, Steinhagen E, Shogan BD, Goldberg JE, Feingold DL, Lightner AL, Paquette IM. Clinical Practice Guidelines for Enhanced Recovery After Colon and Rectal Surgery From the American Society of Colon and Rectal Surgeons and the Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum 2023; 66:15-40. [PMID: 36515513 PMCID: PMC9746347 DOI: 10.1097/dcr.0000000000002650] [Citation(s) in RCA: 25] [Impact Index Per Article: 12.5] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Affiliation(s)
- Jennifer L. Irani
- Department of Surgery, Division of Colorectal Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
| | - Traci L. Hedrick
- Department of Surgery, University of Virginia Health System, Charlottesville, Virginia
| | - Timothy E. Miller
- Department of Anesthesiology, Duke University, Durham, North Carolina
| | - Lawrence Lee
- Department of Surgery, McGill University, Montreal, Quebec, Canada
| | - Emily Steinhagen
- Department of Surgery, University Hospital Cleveland Medical Center, Cleveland, Ohio
| | - Benjamin D. Shogan
- Department of Surgery, University of Chicago Pritzker School of Medicine, Chicago, Illinois
| | - Joel E. Goldberg
- Department of Surgery, Division of Colorectal Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
| | - Daniel L. Feingold
- Department of Surgery, Section of Colorectal Surgery, Rutgers University, New Brunswick, New Jersey
| | - Amy L. Lightner
- Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland Clinic
| | - Ian M. Paquette
- Division of Colon and Rectal Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio
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Irani JL, Hedrick TL, Miller TE, Lee L, Steinhagen E, Shogan BD, Goldberg JE, Feingold DL, Lightner AL, Paquette IM. Clinical practice guidelines for enhanced recovery after colon and rectal surgery from the American Society of Colon and Rectal Surgeons and the Society of American Gastrointestinal and Endoscopic Surgeons. Surg Endosc 2023; 37:5-30. [PMID: 36515747 PMCID: PMC9839829 DOI: 10.1007/s00464-022-09758-x] [Citation(s) in RCA: 21] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 11/04/2022] [Indexed: 12/15/2022]
Abstract
The American Society of Colon and Rectal Surgeons (ASCRS) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) are dedicated to ensuring high-quality innovative patient care for surgical patients by advancing the science, prevention, and management of disorders and diseases of the colon, rectum, and anus as well as minimally invasive surgery. The ASCRS and SAGES society members involved in the creation of these guidelines were chosen because they have demonstrated expertise in the specialty of colon and rectal surgery and enhanced recovery. This consensus document was created to lead international efforts in defining quality care for conditions related to the colon, rectum, and anus and develop clinical practice guidelines based on the best available evidence. While not proscriptive, these guidelines provide information on which decisions can be made and do not dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, healthcare workers, and patients who desire information about the management of the conditions addressed by the topics covered in these guidelines. These guidelines should not be deemed inclusive of all proper methods of care nor exclusive of methods of care reasonably directed toward obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all the circumstances presented by the individual patient. This clinical practice guideline represents a collaborative effort between the American Society of Colon and Rectal Surgeons (ASCRS) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and was approved by both societies.
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Affiliation(s)
- Jennifer L Irani
- Department of Surgery, Division of Colorectal Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Traci L Hedrick
- Department of Surgery, University of Virginia Health System, Charlottesville, VA, USA
| | - Timothy E Miller
- Duke University Medical Center Library, Duke University School of Medicine, Durham, NC, USA
| | - Lawrence Lee
- Department of Surgery, McGill University, Montreal, QC, Canada
| | - Emily Steinhagen
- Department of Surgery, University Hospital Cleveland Medical Center, Cleveland, OH, USA
| | - Benjamin D Shogan
- Department of Surgery, University of Chicago Pritzker School of Medicine, Chicago, IL, USA
| | - Joel E Goldberg
- Department of Surgery, Division of Colorectal Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Daniel L Feingold
- Section of Colorectal Surgery, Rutgers University, New Brunswick, NJ, USA
| | - Amy L Lightner
- Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland Clinic, Cleveland, USA
| | - Ian M Paquette
- Division of Colon and Rectal Surgery, University of Cincinnati College of Medicine Surgery (Colon and Rectal), 222 Piedmont #7000, Cincinnati, OH, 45219, USA.
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Kluger MD, Huang YY, Kuo JH, Kwon W, Thomas AS, Hershman DL, Schrope BA, Sugahara KN, Chabot JA, Wright JD. Perioperative and persistent opioid utilization following pancreatectomy in the United States. HPB (Oxford) 2022; 24:912-924. [PMID: 34815188 DOI: 10.1016/j.hpb.2021.10.021] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/08/2021] [Revised: 07/08/2021] [Accepted: 10/29/2021] [Indexed: 12/12/2022]
Abstract
BACKGROUND Opioids are central to analgesia for pancreatic diseases. Individuals undergoing pancreatectomy have largely been excluded from studies of opioid use, because of malignancy or chronic use. Surgeons need to understand usage patterns, and practices that may incline patients toward persistent post-operative use. METHODS A retrospective study using IBM Watson Health MarketScan database examined patterns of peri-pancreatectomy opioid use between 2009 and 2017. Patients were grouped by opioid use 12 months to 31 days prior to pancreatectomy and followed for persistent use (refills 90-180 days postoperatively). Morphine milligram equivalents (MME) were calculated. Multivariable models explored associations between clinical characteristics, perioperative use and persistent use. RESULTS Opioids were used within the year prior to surgery by 35.6% of 8325 patients. The median MME for opioid naïve patients (400 mg) was a fraction of the 1800 mg prescribed to chronic opioid users for peri-operative analgesia. The rate of persistent opioid use was 15.1% among naïve, 27.2% among intermittent and 77.3% among chronic opioid users. Multivariable models demonstrated naïve and intermittent users who filled a prescription within 30 days prior to pancreatectomy, those who were prescribed total MME ≥1500 mg, and a ≥14 day supply were most at risk of persistent opioid use. Almost 23% of chronic users stopped using opioids post-operatively, suggesting surgery can provide relief. CONCLUSION Preoperative and persistent opioid use after pancreatectomy is substantially greater than expected based on other operations. Providers may mitigate this by recognizing the issue, managing expectations, and altering the timing and quantities of opioids prescribed.
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Affiliation(s)
- Michael D Kluger
- Division of GI/Endocrine Surgery, Department of Surgery, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
| | - Yongmei Y Huang
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA
| | - Jennifer H Kuo
- Division of GI/Endocrine Surgery, Department of Surgery, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA
| | - Wooil Kwon
- Division of GI/Endocrine Surgery, Department of Surgery, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA
| | - Alexander S Thomas
- Division of GI/Endocrine Surgery, Department of Surgery, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA
| | - Dawn L Hershman
- Division of Hematology/Oncology, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA; Herbert Irving Comprehensive Cancer Center, New York, NY, USA
| | - Beth A Schrope
- Division of GI/Endocrine Surgery, Department of Surgery, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA
| | - Kazuki N Sugahara
- Division of GI/Endocrine Surgery, Department of Surgery, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA
| | - John A Chabot
- Division of GI/Endocrine Surgery, Department of Surgery, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA; Herbert Irving Comprehensive Cancer Center, New York, NY, USA
| | - Jason D Wright
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA; Herbert Irving Comprehensive Cancer Center, New York, NY, USA
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10
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de Gaay Fortman DPE, Kroon HM, Bedrikovetski S, Fitzsimmons TR, Dudi-Venkata NN, Sammour T. A snapshot of intraoperative conditions to predict prolonged postoperative ileus after colorectal surgery. ANZ J Surg 2022; 92:2199-2206. [PMID: 35579059 DOI: 10.1111/ans.17784] [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: 10/08/2021] [Revised: 03/28/2022] [Accepted: 04/15/2022] [Indexed: 11/28/2022]
Abstract
BACKGROUND The cause of prolonged postoperative ileus (PPOI) is multifactorial. The influence of preoperative factors on PPOI has been well documented, but little is known about the impact of intraoperative conditions. The aim of this study was to investigate the influence of intraoperative factors on PPOI in patients undergoing colorectal surgery. METHODS The LekCheck study database of the Colorectal Unit at the Royal Adelaide Hospital was analysed. Per patient, over 60 data points were prospectively collected between March 2018 and July 2020. Intraoperative data were collected in theatre during a one-off snapshot measure. Univariate and multivariable logistic regression analyses were performed. RESULTS Data of 336 patients were included. The median age was 66 years and 58.3% were male. Ninety-three patients (27.7%) developed PPOI. Univariate analysis identified the following intraoperative variables as risk-factors of PPOI: greater volumes of intraoperative IV fluid administration (464 versus 415 mL/h for those without PPOI; p = 0.04), side-to-side anastomosis orientation (53.8 versus 41.2%; p = 0.04) and increased perioperative opioid use (6.73 versus 4.11 mg/kg morphine equivalents for patients with and without PPOI, respectively; p = 0.02). Upon multivariable analysis, increased perioperative opioid use remained significant (p = 0.05), as well as the preoperative factors anticoagulation use (p = 0.04) and higher levels of serum total protein (p = 0.02). CONCLUSION This study suggests that intraoperative factors may also contribute to the development of PPOI, but this could not be confirmed in the multivariate analysis. Further studies including larger patient numbers will be required to determine the impact of intraoperative conditions on the development of PPOI.
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Affiliation(s)
- Duveke P E de Gaay Fortman
- Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.,Faculty of Medical Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | - Hidde M Kroon
- Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.,Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia
| | - Sergei Bedrikovetski
- Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.,Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia
| | - Tracy R Fitzsimmons
- Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.,Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia
| | - Nagendra N Dudi-Venkata
- Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.,Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia
| | - Tarik Sammour
- Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.,Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia
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11
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Paterson HM, Cotton S, Norrie J, Nimmo S, Foo I, Balfour A, Speake D, MacLennan G, Stoddart A, Innes K, Cameron S, Aucott L, McCormack K. The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery. Trials 2022; 23:84. [PMID: 35090535 PMCID: PMC8795946 DOI: 10.1186/s13063-022-06021-5] [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] [Subscribe] [Scholar Register] [Received: 08/20/2021] [Accepted: 12/23/2021] [Indexed: 11/15/2022] Open
Abstract
Background Return of gastrointestinal (GI) function is fundamental to patient recovery after colorectal surgery and is required before patients can be discharged from hospital safely. Up to 40% of patients suffer delayed return of GI function after colorectal surgery, causing nausea, vomiting and abdominal discomfort, resulting in longer hospital stay. Small, randomised studies have suggested perioperative intravenous (IV) lidocaine, which has analgesic and anti-inflammatory effects, may accelerate return of GI function after colorectal surgery. The ALLEGRO trial is a pragmatic effectiveness study to assess the benefit of perioperative IV lidocaine in improving return of GI function after elective minimally invasive (laparoscopic or robotic) colorectal surgery. Methods United Kingdom (UK) multi-centre double blind placebo-controlled randomised controlled trial in 562 patients undergoing elective minimally invasive colorectal resection. IV lidocaine or placebo will be infused for 6–12 h commencing at the start of surgery as an adjunct to usual analgesic/anaesthetic technique. The primary outcome will be return of GI function. Discussion A 6–12-h perioperative intravenous infusion of 2% lidocaine is a cheap addition to usual anaesthetic/analgesic practice in elective colorectal surgery with a low incidence of adverse side-effects. If successful in achieving quicker return of gut function for more patients, it would reduce the rate of postoperative ileus and reduce the duration of inpatient recovery, resulting in reduced pain and discomfort with faster recovery and discharge from hospital. Since colorectal surgery is a common procedure undertaken in every acute hospital in the UK, a reduced length of stay and reduced rate of postoperative ileus would accrue significant cost savings for the National Health Service (NHS). Trial registration EudraCT Number 2017-003835-12; REC Number 17/WS/0210 the trial was prospectively registered (ISRCTN Number: ISRCTN52352431); date of registration 13 June 2018; date of enrolment of first participant 14 August 2018.
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Affiliation(s)
| | - Seonaidh Cotton
- Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK
| | - John Norrie
- Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK
| | - Susan Nimmo
- Anaesthetics Department, Western General Hospital, Edinburgh, UK
| | - Irwin Foo
- Anaesthetics Department, Western General Hospital, Edinburgh, UK
| | - Angie Balfour
- Colorectal Surgery, Western General Hospital, Edinburgh, UK
| | - Doug Speake
- Colorectal Surgery, Western General Hospital, Edinburgh, UK
| | - Graeme MacLennan
- Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK
| | - Andrew Stoddart
- Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK
| | - Karen Innes
- Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
| | - Sarah Cameron
- Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK
| | - Lorna Aucott
- Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK
| | - Kirsty McCormack
- Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK
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12
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Buscail E, Deraison C. Postoperative Ileus: a Pharmacological Perspective. Br J Pharmacol 2022; 179:3283-3305. [PMID: 35048360 DOI: 10.1111/bph.15800] [Citation(s) in RCA: 16] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2021] [Revised: 12/31/2021] [Accepted: 01/05/2022] [Indexed: 11/29/2022] Open
Abstract
Post-operative ileus (POI) is a frequent complication after abdominal surgery. The consequences of POI can be potentially serious such as bronchial inhalation or acute functional renal failure. Numerous advances in peri-operative management, particularly early rehabilitation, have made it possible to decrease POI. Despite this, the rate of prolonged POI ileus remains high and can be as high as 25% of patients in colorectal surgery. From a pathophysiological point of view, POI has two phases, an early neurological phase and a later inflammatory phase, to which we could add a "pharmacological" phase during which analgesic drugs, particularly opiates, play a central role. The aim of this review article is to describe the phases of the pathophysiology of POI, to analyse the pharmacological treatments currently available through published clinical trials and finally to discuss the different research areas for potential pharmacological targets.
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Affiliation(s)
- Etienne Buscail
- IRSD, INSERM, INRAE, ENVT, University of Toulouse, CHU Purpan (University Hospital Centre), Toulouse, France.,Department of digestive surgery, colorectal surgery unit, Toulouse University Hospital, Toulouse, France
| | - Céline Deraison
- IRSD, INSERM, INRAE, ENVT, University of Toulouse, CHU Purpan (University Hospital Centre), Toulouse, France
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13
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Mazzotta E, Villalobos-Hernandez EC, Fiorda-Diaz J, Harzman A, Christofi FL. Postoperative Ileus and Postoperative Gastrointestinal Tract Dysfunction: Pathogenic Mechanisms and Novel Treatment Strategies Beyond Colorectal Enhanced Recovery After Surgery Protocols. Front Pharmacol 2020; 11:583422. [PMID: 33390950 PMCID: PMC7774512 DOI: 10.3389/fphar.2020.583422] [Citation(s) in RCA: 76] [Impact Index Per Article: 15.2] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/16/2020] [Accepted: 09/29/2020] [Indexed: 12/11/2022] Open
Abstract
Postoperative ileus (POI) and postoperative gastrointestinal tract dysfunction (POGD) are well-known complications affecting patients undergoing intestinal surgery. GI symptoms include nausea, vomiting, pain, abdominal distention, bloating, and constipation. These iatrogenic disorders are associated with extended hospitalizations, increased morbidity, and health care costs into the billions and current therapeutic strategies are limited. This is a narrative review focused on recent concepts in the pathogenesis of POI and POGD, pipeline drugs or approaches to treatment. Mechanisms, cellular targets and pathways implicated in the pathogenesis include gut surgical manipulation and surgical trauma, neuroinflammation, reactive enteric glia, macrophages, mast cells, monocytes, neutrophils and ICC's. The precise interactions between immune, inflammatory, neural and glial cells are not well understood. Reactive enteric glial cells are an emerging therapeutic target that is under intense investigation for enteric neuropathies, GI dysmotility and POI. Our review emphasizes current therapeutic strategies, starting with the implementation of colorectal enhanced recovery after surgery protocols to protect against POI and POGD. However, despite colorectal enhanced recovery after surgery, it remains a significant medical problem and burden on the healthcare system. Over 100 pipeline drugs or treatments are listed in Clin.Trials.gov. These include 5HT4R agonists (Prucalopride and TAK 954), vagus nerve stimulation of the ENS-macrophage nAChR cholinergic pathway, acupuncture, herbal medications, peripheral acting opioid antagonists (Alvimopen, Methlnaltexone, Naldemedine), anti-bloating/flatulence drugs (Simethiocone), a ghreline prokinetic agonist (Ulimovelin), drinking coffee, and nicotine chewing gum. A better understanding of the pathogenic mechanisms for short and long-term outcomes is necessary before we can develop better prophylactic and treatment strategies.
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Affiliation(s)
- Elvio Mazzotta
- Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, United States
| | | | - Juan Fiorda-Diaz
- Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, United States
| | - Alan Harzman
- Department of Surgery, The Ohio State University Wexner Medical Center, Columbus, OH, United States
| | - Fievos L. Christofi
- Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, United States
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14
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Schwartz J, Gan TJ. Management of postoperative nausea and vomiting in the context of an Enhanced Recovery after Surgery program. Best Pract Res Clin Anaesthesiol 2020; 34:687-700. [PMID: 33288119 DOI: 10.1016/j.bpa.2020.07.011] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/22/2020] [Revised: 07/09/2020] [Accepted: 07/14/2020] [Indexed: 02/07/2023]
Abstract
The concept of Enhanced Recovery after Surgery (ERAS) emerged at the turn of the millennium and quickly gained footing worldwide leading to the establishment of institutional ERAS protocols and subspecialty guidelines. While the use of postoperative nausea and vomiting (PONV) prophylaxis predates ERAS by a significant extent, the emergence of ERAS amplified the importance of antiemetic prophylaxis in perioperative care and drew attention to the truly multifactorial nature of postoperative gastrointestinal dysfunction. The following discussion will review key paradigms behind PONV prophylaxis and ERAS, highlight the interrelationship between these two endeavors, and then explore subspecialty ERAS guidelines that uniquely influence PONV prophylaxis. Attention will center on the ERAS Society guidelines (ESGs) as the primary representative of current ERAS practice, though many deviations from the guidelines exist within the literature and institutional practices.
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Affiliation(s)
- Jonathon Schwartz
- Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY 11794-8480, USA.
| | - Tong J Gan
- Department of Anesthesiology, Stony Brook Medicine, Stony Brook, NY 11794-8480, USA.
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15
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Kelley SR, Wolff BG, Lovely JK, Larson DW. Fast-track Pathway for Minimally Invasive Colorectal Surgery with and without Alvimopan (Entereg)™: Which is More Cost-effective? Am Surg 2020. [DOI: 10.1177/000313481307900626] [Citation(s) in RCA: 20] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Multimodal fast-track (FT) pathways for both open and laparoscopic colorectal surgery have been shown to improve gastrointestinal recovery, shorten length of stay, and decrease morbidity. The aim of our study was to determine if using alvimopan (Entereg)™ in the setting of a FT minimally invasive colorectal pathway is beneficial and cost-effective. All minimally invasive colorectal surgeries performed by one surgeon using a multimodal FT pathway with and without alvimopan were reviewed. Ninety total patients were identified, 64 patients treated without and 26 with alvimopan. Main outcomes included postoperative day tolerating a soft diet, return of gastrointestinal function, length of stay, 30-day readmission rate, and patient care, anesthesia, pharmacy, and combined cost. Tolerance of a soft diet, return of gastrointestinal function, and length of stay were all shorter and showed significance in the alvimopan group (mean 2.1 vs 2.8 days, mean 1.5 vs 2.4 days, and mean 3.5 vs 4.5 days, respectively) ( P = 0.0197, P = 0.0029, and 0.0158, respectively). Patient care and combined hospital costs were both increased in the nonalvimopan group; however, combined hospital costs was not significant ( P = 0.0216 and P = 0.0875, respectively). The 30-day readmission rate of 6.3 per cent was also not significant in this group ( P = 0.0941). Patients undergoing minimally invasive colorectal surgery treated with a multimodal FT pathway tolerated a soft diet sooner, had earlier return of bowel function, a shorter length of stay, and lower patient care and combined costs when alvimopan was used.
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Affiliation(s)
- Scott R. Kelley
- Department of Colon and Rectal Surgery, Rochester, Minnesota
| | - Bruce G. Wolff
- Department of Colon and Rectal Surgery, Rochester, Minnesota
| | - Jenna K. Lovely
- Hospital Pharmacy Services, Mayo Clinic, Rochester, Minnesota
| | - David W. Larson
- Department of Colon and Rectal Surgery, Rochester, Minnesota
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16
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De Roo AC, Vu JV, Regenbogen SE. Statewide Utilization of Multimodal Analgesia and Length of Stay After Colectomy. J Surg Res 2019; 247:264-270. [PMID: 31706540 DOI: 10.1016/j.jss.2019.10.014] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2019] [Revised: 09/23/2019] [Accepted: 10/05/2019] [Indexed: 12/20/2022]
Abstract
BACKGROUND Both enhanced recovery and anesthesia literature recommend multimodal perioperative analgesia to hasten recovery, prevent adverse events, and reduce opioid use after surgery. However, adherence to, and outcomes of, these recommendations are unknown. We sought to characterize use of multimodal analgesia and its association with length of stay after colectomy. MATERIALS AND METHODS Within a statewide, 72-hospital collaborative quality initiative, we evaluated postoperative analgesia regimens among adult patients undergoing elective colectomy between 2012 and 2015. We used logistic regression to identify factors associated with the use of multimodal analgesia and performed multivariable linear regression to evaluate its association with postoperative length of stay (LOS). RESULTS Among 7265 patients who underwent elective colectomy in the study period, 4660 (64.1%) received multimodal analgesia, 2405 (33.1%) received opioids alone, and 200 (2.8%) received one nonopioid pain medication alone. Multimodal analgesia was independently associated with shorter adjusted postoperative LOS, compared with opioids alone (5.60 d [95% CI 5.38-5.81] versus 5.96 d [5.68-6.24], P = 0.016). CONCLUSIONS Multimodal analgesia is associated with shorter LOS, yet one-third of patients statewide received opioids alone after colectomy. As surgeons increasingly focus on our role in the opioid crisis, particularly in postdischarge opioid prescribing, we must also focus on inpatient postoperative pain management to limit opioid exposure. At the hospital level, this may have the added benefit of decreasing LOS and hastening recovery.
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Affiliation(s)
- Ana C De Roo
- Department of Surgery, Michigan Medicine, Ann Arbor, Michigan; Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, Michigan.
| | - Joceline V Vu
- Department of Surgery, Michigan Medicine, Ann Arbor, Michigan; Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, Michigan
| | - Scott E Regenbogen
- Department of Surgery, Michigan Medicine, Ann Arbor, Michigan; Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, Michigan; Michigan Surgical Quality Collaborative, Ann Arbor, Michigan
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17
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Duncan C, Teh J, Lawrentschuk N. Alvimopan for post-radical cystectomy ileus: what should we know? Transl Androl Urol 2019; 8:S96-S98. [PMID: 31143679 DOI: 10.21037/tau.2019.02.01] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022] Open
Affiliation(s)
- Catriona Duncan
- Department of Surgery, Urology Unit, University of Melbourne, Austin Hospital, Melbourne, Australia.,North Eastern Urology, Melbourne, Australia
| | - Jiasian Teh
- Department of Surgery, Urology Unit, University of Melbourne, Austin Hospital, Melbourne, Australia.,Department of Surgical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.,EJ Whitten Prostate Cancer Research Centre at Epworth Healthcare, Melbourne, Australia
| | - Nathan Lawrentschuk
- Department of Surgery, Urology Unit, University of Melbourne, Austin Hospital, Melbourne, Australia.,Department of Surgical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.,EJ Whitten Prostate Cancer Research Centre at Epworth Healthcare, Melbourne, Australia
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18
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Nishie K, Yamamoto S, Yamaga T, Horigome N, Hanaoka M. Peripherally acting μ-opioid antagonist for the treatment of opioid-induced constipation: Systematic review and meta-analysis. J Gastroenterol Hepatol 2019; 34:818-829. [PMID: 30597600 DOI: 10.1111/jgh.14586] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/10/2018] [Revised: 12/08/2018] [Accepted: 12/22/2018] [Indexed: 12/29/2022]
Abstract
BACKGROUND AND AIM Opioid-induced constipation (OIC) is a frequent adverse event (AE) that impairs patients' quality of life (QOL). Peripherally acting μ-opioid receptor antagonists (PAMORAs) have been recognized as a treatment option for OIC, but the effect consistent across the studies has not been evaluated. METHODS We conducted a quantitative meta-analysis to explore the efficacy of PAMORA for OIC (registered with PROSPERO: CRD42018085298). We systematically searched randomized controlled trials (RCTs) in Medline, Embase, and Central databases. Change from baseline in spontaneous bowel movements, pooled proportion of responders, QOL, and AEs were calculated and compared with results in placebo cases. RESULTS We included 31 RCTs with 7849 patients. A meta-analysis revealed that patients under PAMORA therapy had considerably improved spontaneous bowel movement from baseline compared with those given placebo (20 RCTs; mean difference, 1.43; 95% confidence interval [CI], 1.18-1.68; n = 5622) and more responded (21 RCTs; risk ratio [RR], 1.81; 95% CI, 1.55-2.12; n = 4821). Moreover, QOL of patients receiving PAMORA was significantly better (8 RCTs; mean difference, -0.22; 95% CI, -0.28 to -0.17; n = 2884). AEs were increased significantly in the PAMORA group (26 RCTs; RR, 1.10; 95% CI, 1.06-1.15; n = 7715), especially in gastrointestinal disorders, whereas serious AEs were not significant (17 RCTs; RR, 1.04; 95% CI, 0.85-1.28; n = 5890). CONCLUSION Peripherally acting μ-opioid receptor antagonist has been shown to be effective and durable for patients with OIC and is the only drug with confirmed evidence in meta-analysis. The possibility of publication bias was the limitation of this study.
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Affiliation(s)
- Kenichi Nishie
- Department of Respiratory Medicine, Iida Municipal Hospital, Iida, Nagano, Japan.,The First Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Japan
| | - Shuhei Yamamoto
- Department of Rehabilitation, Shinshu University Hospital, Matsumoto, Japan
| | - Takayoshi Yamaga
- Department of Occupational Therapy, Health Science University, Fujikawaguchikomachi, Yamanashi, Japan
| | - Naoto Horigome
- Department of Digestive Surgery, Iida Municipal Hospital, Iida, Nagano, Japan
| | - Masayuki Hanaoka
- The First Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Japan
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19
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Simianu VV, Kumar AS. Surgical Care and Outcomes Assessment Program (SCOAP): A Nuanced, Flexible Platform for Colorectal Surgical Research. Clin Colon Rectal Surg 2019; 32:25-32. [PMID: 30647543 DOI: 10.1055/s-0038-1673351] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
The Surgical Care and Outcomes Assessment Program (SCOAP) is a surgeon-led quality improvement (QI) initiative developed in Washington State to track and reduce variability in surgical care. It has developed into a collaboration of over two-thirds of the hospitals in the state, who share data and receive regular benchmarking reports. Data are abstracted at each site by trained abstractors. While there has some overlap with other national QI databases, the data captured by SCOAP has clinical nuances that make it pragmatic for studying surgical care. We review the unique properties of SCOAP and offer some examples of its novel applications.
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Affiliation(s)
- Vlad V Simianu
- Colorectal Surgery Program, Virginia Mason Medical Center, Seattle, Washington
| | - Anjali S Kumar
- Elson S. Floyd College of Medicine, Washington State University, Everett, Spokane, Tri-Cities, and Vancouver, Washington
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20
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Al-Mazrou AM, Baser O, Kiran RP. Alvimopan, Regardless of Ileus Risk, Significantly Impacts Ileus, Length of Stay, and Readmission After Intestinal Surgery. J Gastrointest Surg 2018; 22:2104-2116. [PMID: 29987738 DOI: 10.1007/s11605-018-3846-2] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/14/2018] [Accepted: 06/13/2018] [Indexed: 01/31/2023]
Abstract
BACKGROUND Previous analyses evaluating alvimopan included patients at varying risk for ileus after intestinal resection, which may have precluded its widespread adoption. We assess the early and delayed effects of alvimopan in patients stratified by risk for ileus after intestinal and colon resection. METHODS From the Premier Perspective database, patients with elective small and large bowel resections from 2012 to 2014 were identified. Multivariable analysis identified 14 perioperative risk factors for postoperative ileus. Within low- (0-4 factors), intermediate- (5 factors), and high-risk (6-12 factors) ileus categories, alvimopan and no-alvimopan patients were propensity-score matched for demographics, morbidities, diagnosis, surgery and approach, postoperative complications, surgeon specialty, and hospital features. In-hospital postoperative ileus, length of stay, discharge destination, and ileus-related readmission were compared. RESULTS Of 52,948 patients, 15,719 (29.7%) received alvimopan. Risk for ileus in low- (18,784), intermediate- (14,370), and high-risk (19,794) categories was 8.9, 13, and 22% (p ≤ .0001) respectively. After matching, alvimopan was associated with significantly reduced in-hospital postoperative ileus in all (low, 6%; intermediate, 9.4%; and high risk, 16.2%) categories. Hospital stay and 30-, 60-, and 90-day postdischarge ileus were also significantly lower with alvimopan. For low-risk patients, alvimopan increased discharge to home, while 90-day emergency readmission was reduced. CONCLUSIONS Alvimopan, regardless of ileus risk, improves ileus, hospital stay, and ileus-related readmission after intestinal resection and these effects are sustained over the long term. Since fewer than a third of patients currently receive alvimopan, its routine adoption with small and large intestinal resection will significantly impact patients and health systems.
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Affiliation(s)
- Ahmed M Al-Mazrou
- Division of Colorectal Surgery, NewYork-Presbyterian Hospital/Columbia University Medical Center, Herbert Irving Pavilion, 161 Fort Washington Avenue, Floor 8, New York, NY, 10032, USA
| | - Onur Baser
- Center for Innovation and Outcomes Research, Department of Surgery, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA
| | - Ravi P Kiran
- Division of Colorectal Surgery, NewYork-Presbyterian Hospital/Columbia University Medical Center, Herbert Irving Pavilion, 161 Fort Washington Avenue, Floor 8, New York, NY, 10032, USA.
- Center for Innovation and Outcomes Research, Department of Surgery, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA.
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21
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Evaluation of Healthcare Use and Clinical Outcomes of Alvimopan in Patients Undergoing Bowel Resection: A Propensity Score-Matched Analysis. Dis Colon Rectum 2018; 61:1418-1425. [PMID: 30312222 DOI: 10.1097/dcr.0000000000001181] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND Postoperative ileus is a significant complication after bowel resection surgeries. Alvimopan is the only US Food and Drug Administration-approved therapy for accelerating the return of bowel function after large- and small-bowel resection. OBJECTIVE The purpose of this study was to estimate the healthcare use and in-hospital morbidities associated with on-label use of alvimopan in patients undergoing bowel resection surgeries. DESIGN A retrospective observational propensity-matched cohort study was conducted using a large hospital administrative database. SETTING The study included inpatient postsurgical patients. PATIENTS Patients aged ≥18 years undergoing a primary large or small segmental bowel resection with discharge dates between January 2010 and December 2014 were included. INTERVENTIONS Patients receiving 2 to 15 doses of alvimopan were defined as the treatment cohort, and those without any alvimopan use were included as control subjects. MAIN OUTCOME MEASURES The primary outcome was postoperative length of stay. Secondary outcomes included postoperative in-hospital morbidities, inpatient mortality, intensive care unit length of stay, discharge disposition, and 30-day readmission. RESULTS Each propensity-score matched cohort included 18,559 patients. The mean (±SD) postoperative length of stay was 4.62 ± 2.45 days in alvimopan-treated patients compared with 5.24 ± 3.35 days in control subjects (p < 0.001). Alvimopan-treated patients had lower rates of postoperative GI complication (12.15% vs 16.50%; p < 0.001). The rates of urinary tract infections; other postoperative infections; and cardiovascular, pulmonary, thromboembolic, and cerebrovascular events were also lower compared with the control subjects. LIMITATIONS The study was limited by its inability to generalize to the US population, because the database included a convenience sample of hospital discharges. The identification of patients undergoing bowel resection and their clinical conditions relied on the accuracy and completeness of International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis and procedure coding. There may be a confounding effect by the use of enhanced recovery pathways associated with the use of alvimopan. CONCLUSIONS The use of alvimopan was associated with a reduction of 0.62 days in postsurgery length of stay and lower rates of postoperative GI complications, infections, and other in-hospital morbidities. See Video Abstract at http://links.lww.com/DCR/A703.
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22
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Chae M, Lee H, Park CO, Hong SH. Enhanced recovery after surgery:an anesthesiologist’s perspective. Anesth Pain Med (Seoul) 2018. [DOI: 10.17085/apm.2018.13.4.372] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022] Open
Affiliation(s)
- Minsuk Chae
- Department of Anesthesiology and Pain Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Hyungmook Lee
- Department of Anesthesiology and Pain Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Chan-oh Park
- Department of Anesthesiology and Pain Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Sang Hyun Hong
- Department of Anesthesiology and Pain Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
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Hedrick TL, McEvoy MD, Mythen M(MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Gastrointestinal Dysfunction Within an Enhanced Recovery Pathway for Elective Colorectal Surgery. Anesth Analg 2018; 126:1896-1907. [DOI: 10.1213/ane.0000000000002742] [Citation(s) in RCA: 97] [Impact Index Per Article: 13.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/19/2023]
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Dhekale NH, Gunjal DB, Gore AH, Komaravolu Y, Hima Bindu K, Kolekar GB. Stereoselective HPLC separation of alvimopan on cellulose-based immobilized polysaccharide as a chiral stationary phase. Chirality 2018; 30:982-987. [PMID: 29782664 DOI: 10.1002/chir.22859] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/21/2017] [Revised: 01/30/2018] [Accepted: 02/17/2018] [Indexed: 11/07/2022]
Abstract
Chiral separation by normal phase high performance liquid chromatography is one of the most powerful technique to quantify the chiral purity of the compounds. In this study, a novel, simple, and specific analytical method was proposed to ascertain the chiral purity of alvimopan (ALV). The normal phase HPLC method was developed based on cellulose tris (3,5-dichlorophenylcarbamate) stationary phase. The separation of ALV isomers achieved by using column CHIRALPAK IC (250 × 4.6 mm, 5 μm), mobile phase n-hexane: isopropyl alcohol: ethanol: diethylamine (650:200:150:5 v/v), column oven temperature 30°C, flow rate 1.0 mL min-1 , injection volume was 10 μL, chromatographic response monitored at 273 nm. The developed method was validated as per the ICH guidelines and found precise, accurate, and linear. The advantage of the method is a good separation of ALV isomers within 35 minutes of the analysis time. Therefore, this method is suitable for routine determination of chiral purity of ALV active pharmaceutical ingredient.
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Affiliation(s)
- Nitin H Dhekale
- Fluorescence Spectroscopy Research Laboratory, Department of Chemistry, Shivaji University, Kolhapur, 416 004, Maharashtra, India
- Analytical Research and Development, Dr. Reddy's Laboratories Ltd. Hyderabad, Hyderabad, 500 090, Telangana, India
| | - Dattatray B Gunjal
- Fluorescence Spectroscopy Research Laboratory, Department of Chemistry, Shivaji University, Kolhapur, 416 004, Maharashtra, India
| | - Anil H Gore
- Fluorescence Spectroscopy Research Laboratory, Department of Chemistry, Shivaji University, Kolhapur, 416 004, Maharashtra, India
- Rajarshi Chhatrapati Shahu College Kolhapur, 416 004, Maharashtra, India
| | - Yagnakirankumar Komaravolu
- Analytical Research and Development, Dr. Reddy's Laboratories Ltd. Hyderabad, Hyderabad, 500 090, Telangana, India
| | - K Hima Bindu
- Analytical Research and Development, Dr. Reddy's Laboratories Ltd. Hyderabad, Hyderabad, 500 090, Telangana, India
| | - Govind B Kolekar
- Fluorescence Spectroscopy Research Laboratory, Department of Chemistry, Shivaji University, Kolhapur, 416 004, Maharashtra, India
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Loftus TJ, Stelton S, Efaw BW, Bloomstone J. A System-Wide Enhanced Recovery Program Focusing on Two Key Process Steps Reduces Complications and Readmissions in Patients Undergoing Bowel Surgery. J Healthc Qual 2018; 39:129-135. [PMID: 28481841 DOI: 10.1111/jhq.12068] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Abstract
Enhanced recovery programs (ERPs) can improve outcomes following bowel surgery, but implementing an ERP across a large healthcare system remains challenging. In this study, a simplified ERP that focused on two process steps, early and frequent ambulation and early alimentation, was evaluated to determine its impact on outcomes. Data were collected on 5,000 adult patients undergoing elective small and large bowel operations over a 3-year period. Complication, readmission, and mortality rates were evaluated before and after ERP implementation. A composite score was calculated based on the successful completion of the two process steps. Following implementation, there was a 35.1% increase in the composite score, which was associated with significant (p < .05) reductions in overall complications, gastrointestinal complications, pulmonary complications, and readmissions. A system-wide ERP focusing on early and frequent ambulation and early alimentation is associated with decreased complications and readmissions in adult patients admitted for elective small or large bowel operations.
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White WB, Kowey P, Diva U, Sostek M, Tummala R. Cardiovascular Safety of the Selective μ-Opioid Receptor Antagonist Naloxegol: A Novel Therapy for Opioid-Induced Constipation. J Cardiovasc Pharmacol Ther 2018; 23:309-317. [DOI: 10.1177/1074248418760239] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Background: Naloxegol is a novel selective, peripherally acting μ-opioid receptor antagonist for treating opioid-induced constipation (OIC) in patients with chronic pain syndromes. We analyzed the cardiovascular (CV) safety of naloxegol based on data from its development program prior to approval by the US Food and Drug Administration in 2015. Methods: Comprehensive CV safety analyses were performed in 4 clinical studies of naloxegol (12.5 and/or 25 mg) in patients with noncancer pain and OIC: two 12-week, double-blind, randomized studies; a 12-week, double-blind, extension study; and a 52-week, randomized, open-label study versus usual care. Evaluations of baseline CV risk were obtained from medical histories and clinical findings at the time of study initiation. Results: Across the 4 studies (N = 2135), 68% of patients had ≥1 CV risk factor and 41% had a history of CV disease, diabetes, or ≥2 other CV risk factors. There were no increases in blood pressure, heart rate, or the rate-pressure product with naloxegol versus placebo. The rates of major adverse cardiovascular events (MACE) per 100 patient-years of exposure were 1.13 (95% confidence interval [CI], 0.31-2.89) for placebo/usual care and 0.75 (95% CI, 0.24-1.75) for naloxegol. The relative risk of MACE for all doses of naloxegol versus placebo was 0.67 (95% CI, 0.14-3.36). Conclusion: These data demonstrate that naloxegol has a CV safety profile comparable to placebo/usual care in patients with OIC. Although the observed number of events was low, the data show no CV signal in patients with OIC treated with naloxegol.
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Affiliation(s)
- William B. White
- Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA
| | - Peter Kowey
- Lankenau Institute for Medical Research, Main Line Health System, Wynnewood, PA, USA
| | - Ulysses Diva
- AstraZeneca Pharmaceuticals LP, Gaithersburg, MD, USA
| | - Mark Sostek
- AstraZeneca Pharmaceuticals LP, Gaithersburg, MD, USA
| | - Raj Tummala
- AstraZeneca Pharmaceuticals LP, Gaithersburg, MD, USA
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Abstract
BACKGROUND Enhanced recovery pathways, also known as fast-track protocols, have been adopted since the early 2000s by various surgical specialties with the goal of improving patient outcomes and reducing the cost burden of major surgery on the health care system. OBJECTIVE To review the scientific literature on the origin of enhanced recovery pathways, track the contemporary utilization of such practices for patients undergoing radical cystectomy, and analyze the available data regarding their effect on morbidity, mortality, and treatment cost. METHODS A literature search of multiple electronic databases was undertaken. Manuscripts including patients undergoing radical cystectomy were chosen based on predefined criteria with an emphasis on randomized controlled trials and cohort studies. Strength of evidence for each study that met inclusion criteria was assessed based on the risk of bias, consistency, directness, and precision. RESULTS Database searches resulted in 1,236 potentially relevant articles. A total of 485 articles were selected for full-text dual review and 106 studies in 52 publications met the inclusion criteria. CONCLUSION The utilization of enhanced recovery pathways with the goal of improving overall patient morbidity and mortality is well supported in the literature, however standardization of implementation and adherence across institutions is lacking, and their direct efficacy on reducing preventable treatment related expenditures is unconfirmed.
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Affiliation(s)
- Ian Maloney
- Department of Urology, The University of Oklahoma Health Sciences Center and The Stephenson Cancer Center, Oklahoma City, OK, USA
| | - Daniel C. Parker
- Department of Urology, The University of Oklahoma Health Sciences Center and The Stephenson Cancer Center, Oklahoma City, OK, USA
| | - Michael S. Cookson
- Department of Urology, The University of Oklahoma Health Sciences Center and The Stephenson Cancer Center, Oklahoma City, OK, USA
| | - Sanjay Patel
- Department of Urology, The University of Oklahoma Health Sciences Center and The Stephenson Cancer Center, Oklahoma City, OK, USA
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Carmichael JC, Keller DS, Baldini G, Bordeianou L, Weiss E, Lee L, Boutros M, McClane J, Steele SR, Feldman LS. Clinical practice guideline for enhanced recovery after colon and rectal surgery from the American Society of Colon and Rectal Surgeons (ASCRS) and Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Surg Endosc 2017; 31:3412-3436. [DOI: 10.1007/s00464-017-5722-7] [Citation(s) in RCA: 35] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2017] [Accepted: 07/10/2017] [Indexed: 12/16/2022]
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Clinical Practice Guidelines for Enhanced Recovery After Colon and Rectal Surgery From the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum 2017; 60:761-784. [PMID: 28682962 DOI: 10.1097/dcr.0000000000000883] [Citation(s) in RCA: 287] [Impact Index Per Article: 35.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
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Alvimopan Provides Additional Improvement in Outcomes and Cost Savings in Enhanced Recovery Colorectal Surgery. Ann Surg 2017; 264:141-6. [PMID: 26501697 DOI: 10.1097/sla.0000000000001428] [Citation(s) in RCA: 30] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
OBJECTIVE To examine the impact of alvimopan on outcomes and costs in a rigorous enhanced recovery colorectal surgery protocol. BACKGROUND Postoperative ileus remains a major source of morbidity and costs in colorectal surgery. Alvimopan has been shown to reduce incidence of postoperative ileus in enhanced recovery colorectal surgery; however, data are equivocal regarding its benefit in reducing length of stay and costs. METHODS Patients undergoing major elective enhanced recovery colorectal surgery were identified from a prospectively-collected database (2010-2013). Multivariable analyses were employed to compare outcomes and hospital costs among patients who had alvimopan versus no alvimopan by adjusting for demographic, clinical, and treatment characteristics. RESULTS A total of 660 patients were included; 197 patients received alvimopan and 463 patients had no alvimopan. In unadjusted analysis, the alvimopan group had a faster return of bowel function, shorter length of stay, and lower rates of ileus, Foley re-insertion, and urinary tract infection (all P < 0.01). After adjustment, alvimopan was associated with a faster return of bowel function by 0.6 day (P = 0.0006), and lower incidence of postoperative ileus (odds ratio 0.23, P = 0.0002). With adjustment, alvimopan was associated with a shorter length of stay by 1.6 days (P = 0.002), and a hospital cost savings of $1492 per patient (P = 0.01). CONCLUSIONS Alvimopan administration as an element of enhanced recovery colorectal surgery is associated with faster return of bowel function, lower incidence of postoperative ileus, shorter hospitalization, and a significant cost savings. These results suggest that alvimopan is cost-effective in the setting of enhanced recovery colorectal surgery protocols, and should therefore be considered in these programs.
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Ellis CN. Discharge criteria after colon resection: Is return of bowel function necessary? Am J Surg 2017; 213:544-547. [DOI: 10.1016/j.amjsurg.2016.11.010] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/06/2016] [Revised: 08/28/2016] [Accepted: 11/05/2016] [Indexed: 12/25/2022]
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Wen Y, Jabir MA, Keating M, Althans AR, Brady JT, Champagne BJ, Delaney CP, Steele SR. Alvimopan in the setting of colorectal resection with an ostomy: To use or not to use? Surg Endosc 2016; 31:3483-3488. [PMID: 27928668 DOI: 10.1007/s00464-016-5373-0] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/19/2016] [Accepted: 11/21/2016] [Indexed: 01/08/2023]
Abstract
BACKGROUND Postoperative ileus (POI) is a major cause of morbidity, increased length of stay (LOS) and hospital cost after colorectal surgery. Alvimopan is a µ-opioid antagonist used to accelerate upper and lower gastrointestinal function after bowel resection. We hypothesized that alvimopan would reduce LOS in patients undergoing colorectal resection with stoma, a situation that has not been evaluated. METHODS A retrospective review (2010-2015) identified 58 patients who underwent colorectal resection for benign or malignant disease with stoma creation and received alvimopan. They were case-matched to 58 non-alvimopan patients based on age, BMI, baseline comorbidities, stoma type created and surgical approach. We compared overall LOS, incidence of POI and other postoperative complications. RESULTS There were equal numbers of laparoscopic (N = 18) and open resections (N = 40) in the alvimopan group and non-alvimopan group. There were also equal numbers of patients with an ileostomy (N = 37) or colostomy (N = 21) in each group. Overall, 41 patients underwent resection for malignant disease in the alvimopan group compared to 37 in the non-alvimopan group. There was a significant reduction in median LOS overall (alvimopan 5 (4-7) versus control 6 (4.75-9.25) days, P = 0.03). While the 6-day median LOS was similar for patients undergoing ileostomy creation (P = 0.25), alvimopan patients had a 3-day decreased median LOS that approached statistical significance (P = 0.06). The overall 30-day complication rate was higher in the control group (41.4 vs. 51.7%, P = 0.26), but the readmission rate within 30 days was higher in the alvimopan group (19 vs. 13.8%, P = 0.45). Neither of these differences reached statistically significance. CONCLUSION The use of alvimopan in patients undergoing colorectal resection with stoma is associated with a significantly shorter LOS, but the increased readmission rate warrants further study. Based on these data, alvimopan should be evaluated in a controlled setting for patients undergoing colorectal resection with colostomy creation.
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Affiliation(s)
- Yuxiang Wen
- Department of Colorectal Surgery, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH, 44016, USA
| | - Murad A Jabir
- Department of Colorectal Surgery, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH, 44016, USA
| | - Michael Keating
- Department of Colorectal Surgery, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH, 44016, USA
| | - Alison R Althans
- Department of Colorectal Surgery, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH, 44016, USA
| | - Justin T Brady
- Department of Colorectal Surgery, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH, 44016, USA.
| | - Bradley J Champagne
- Department of Colorectal Surgery, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH, 44016, USA
| | - Conor P Delaney
- Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA
| | - Scott R Steele
- Department of Colorectal Surgery, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH, 44016, USA
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Alvimopan for post-operative ileus: What we should know? ACTA ACUST UNITED AC 2016; 54:97-98. [PMID: 27825721 DOI: 10.1016/j.aat.2016.10.001] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2016] [Revised: 10/03/2016] [Accepted: 10/11/2016] [Indexed: 12/12/2022]
Abstract
Alvimopan is an US-FDA approved, peripherally acting mu opioid receptor antagonist which when started pre-operatively has been shown to hasten intestinal motility and reduce the duration of post-operative ileus. However the logistics involved in procuring, storing and dispensing the drug and the cost of the drug for fifteen doses as approved by FDA prohibits the use of it on a regular basis.
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Brady JT, Dosokey EMG, Crawshaw BP, Steele SR, Delaney CP. The use of alvimopan for postoperative ileus in small and large bowel resections. Expert Rev Gastroenterol Hepatol 2016; 9:1351-8. [PMID: 26488223 DOI: 10.1586/17474124.2015.1095637] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/16/2023]
Abstract
Transient ileus is a normal physiologic process after surgery. When prolonged, it is an important contributor to postoperative complications, increased length of stay and increased healthcare costs. Efforts have been made to prevent and manage postoperative ileus; alvimopan is an oral, peripheral μ-opioid receptor antagonist, and the only currently US FDA-approved medication to accelerate the return of gastrointestinal function postoperatively.
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Affiliation(s)
- Justin T Brady
- a University Hospitals Case Medical Center, Division of Colorectal Surgery, Cleveland, Ohio, USA
| | - Eslam M G Dosokey
- a University Hospitals Case Medical Center, Division of Colorectal Surgery, Cleveland, Ohio, USA
| | - Benjamin P Crawshaw
- a University Hospitals Case Medical Center, Division of Colorectal Surgery, Cleveland, Ohio, USA
| | - Scott R Steele
- a University Hospitals Case Medical Center, Division of Colorectal Surgery, Cleveland, Ohio, USA
| | - Conor P Delaney
- a University Hospitals Case Medical Center, Division of Colorectal Surgery, Cleveland, Ohio, USA
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Keller DS, Flores-Gonzalez JR, Ibarra S, Mahmood A, Haas EM. Is there value in alvimopan in minimally invasive colorectal surgery? Am J Surg 2016; 212:851-856. [PMID: 27262754 DOI: 10.1016/j.amjsurg.2016.02.016] [Citation(s) in RCA: 28] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2015] [Revised: 02/15/2016] [Accepted: 02/27/2016] [Indexed: 12/01/2022]
Abstract
BACKGROUND Alvimopan's goal is to minimize postoperative ileus and optimize outcomes; however, evidence in laparoscopic surgery is lacking. Our goal was to evaluate the benefit of alvimopan in laparoscopic colorectal surgery with an enhanced recovery pathway (ERP). METHODS Laparoscopic colorectal cases were stratified into alvimopan and control cohorts, then case-matched for comparability. All followed an identical ERP. The main outcomes were length of stay, complications, readmissions, and costs in the alvimopan and control groups. RESULTS About 321 patients were analyzed in each cohort. Operative times were comparable (P = .08). Postoperatively, complication rates were similar (P = .29), with no difference in ileus (P = 1.00). The length of stay (3.69 vs 3.49 days; P = .16), readmission (2.8% vs 3.7%; P = .66) and reoperation rates (2.2% vs 1.6%; P = .77) were comparable for alvimopan and controls, respectively. Total costs were similar ($14,932.47 alvimopan vs $14,846.56 controls; P = .90), but the additional costs in the alvimopan group could translate to savings of $27,577 in the cohort. CONCLUSIONS Alvimopan added no benefit in patient outcomes in laparoscopic colorectal surgery with an ERP. These results could drive a change in current practice. Controlled studies are warranted to define the cost and/or benefit in clinical practice.
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Affiliation(s)
- Deborah S Keller
- Colorectal Surgical Associates, Houston, TX, USA; Department of Surgery, Houston Methodist Hospital, 7900 Fannin, Suite 2700, Houston, TX 77054, USA.
| | | | | | - Ali Mahmood
- Colorectal Surgical Associates, Houston, TX, USA; Department of Surgery, Houston Methodist Hospital, 7900 Fannin, Suite 2700, Houston, TX 77054, USA; Minimally Invasive Colon and Rectal Surgery, The University of Texas Medical School at Houston, Houston, TX, USA
| | - Eric M Haas
- Colorectal Surgical Associates, Houston, TX, USA; Department of Surgery, Houston Methodist Hospital, 7900 Fannin, Suite 2700, Houston, TX 77054, USA; Minimally Invasive Colon and Rectal Surgery, The University of Texas Medical School at Houston, Houston, TX, USA
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Kamiński JP, Pai A, Ailabouni L, Park JJ, Marecik SJ, Prasad LM, Abcarian H. Role of epidural and patient-controlled analgesia in site-specific laparoscopic colorectal surgery. JSLS 2016; 18:JSLS.2014.00207. [PMID: 25419110 PMCID: PMC4234047 DOI: 10.4293/jsls.2014.00207] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/10/2023] Open
Abstract
Background and Objectives: Limited data are available comparing epidural and patient-controlled analgesia in site-specific colorectal surgery. The aim of this study was to evaluate 2 modes of analgesia in patients undergoing laparoscopic right colectomy (RC) and low anterior resection (LAR). Methods: Prospectively collected data on 433 patients undergoing laparoscopic or laparoscopic-assisted colon surgery at a single institution were retrospectively reviewed from March 2004 to February 2009. Patients were divided into groups undergoing RC (n = 175) and LAR (n = 258). These groups were evaluated by use of analgesia: epidural analgesia, “patient-controlled analgesia” alone, and a combination of both. Demographic and perioperative outcomes were compared. Results: Epidural analgesia was associated with a faster return of bowel function, by 1 day (P < .001), in patients who underwent LAR but not in the RC group. Delayed return of bowel function was associated with increased operative time in the LAR group (P = .05), patients with diabetes who underwent RC (P = .037), and patients after RC with combined analgesia (P = .011). Mean visual analogue scale pain scores were significantly lower with epidural analgesia compared with patient-controlled analgesia in both LAR and RC groups (P < .001). Conclusion: Epidural analgesia was associated with a faster return of bowel function in the laparoscopic LAR group but not the RC group. Epidural analgesia was superior to patient-controlled analgesia in controlling postoperative pain but was inadequate in 28% of patients and needed the addition of patient-controlled analgesia.
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Affiliation(s)
- Jan P Kamiński
- Department of Surgery, University of Illinois Metropolitan Group Hospitals, Chicago, Illinois
| | - Ajit Pai
- Division of Colon and Rectal Surgery, Advocate Lutheran General Hospital, Park Ridge, Illinois
| | - Luay Ailabouni
- Division of Colon and Rectal Surgery, Advocate Lutheran General Hospital, Park Ridge, Illinois
| | - John J Park
- Division of Colon and Rectal Surgery, Advocate Lutheran General Hospital, Park Ridge, Illinois
| | - Slawomir J Marecik
- Division of Colon and Rectal Surgery, Advocate Lutheran General Hospital, Park Ridge, Illinois
| | - Leela M Prasad
- Division of Colon and Rectal Surgery, Advocate Lutheran General Hospital, Park Ridge, Illinois
| | - Herand Abcarian
- Division of Colon and Rectal Surgery, John H. Stroger Hospital of Cook County, Chicago, Illinois
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Steenhagen E. Enhanced Recovery After Surgery: It's Time to Change Practice! Nutr Clin Pract 2015; 31:18-29. [PMID: 26703956 DOI: 10.1177/0884533615622640] [Citation(s) in RCA: 72] [Impact Index Per Article: 7.2] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
Perioperative surgical care is undergoing a paradigm shift. Traditional practices such as prolonged preoperative fasting (nil by mouth from midnight), bowel cleaning, and reintroduction of oral nutrition 3-5 days after surgery are being shunned. These and other similar changes have been formulated into a protocol called Enhanced Recovery After Surgery (ERAS) pathway. It is a multimodal perioperative care pathway designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. The key elements of an ERAS protocol include preoperative counseling, optimization of nutrition, standardized analgesic and anesthetic regimes, and early mobilization. The recent literature is heavily influenced by colorectal surgery, but the principles are now being applied to a wide range of disciplines. As they challenge traditional surgical doctrine, the implementation of ERAS guidelines has been slow, despite the significant body of evidence indicating that ERAS guidelines may lead to improved outcomes.
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Affiliation(s)
- Elles Steenhagen
- Internal Medicine and Dermatology, Department of Dietetics, University Medical Center Utrecht, the Netherlands
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Berdún S, Bombuy E, Estrada O, Mans E, Rychter J, Clavé P, Vergara P. Peritoneal mast cell degranulation and gastrointestinal recovery in patients undergoing colorectal surgery. Neurogastroenterol Motil 2015; 27:764-74. [PMID: 25677271 DOI: 10.1111/nmo.12525] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/29/2014] [Accepted: 01/14/2015] [Indexed: 02/08/2023]
Abstract
BACKGROUND Degranulation of peritoneal mast cells (MCs) induced by intestinal manipulation has been proposed as a pathophysiological factor in postoperative ileus (POI). We aimed to explore the relationship between peritoneal and colonic MC degranulation and gastrointestinal (GI) recovery following colectomy. METHODS Patients undergoing elective laparoscopic cholecystectomy (using a laparoscope and small abdominal incisions, n = 14), and elective laparoscopic (n = 32) or open partial colectomy (through a large abdominal incision, n = 10) were studied. MC protease tryptase and chymase were studied in peritoneal fluid at the beginning, middle, and end of each surgical intervention. Density of MCs in colectomy samples were examined and oro-caecal transit time by breath test, GI function recovery by clinical composite endpoint GI-2 and association between MC proteases and clinical recovery. KEY RESULTS Open and laparoscopic colectomy caused greater peritoneal release of tryptase and chymase (323.0 ng/mL [IQR: 53.05-381.4] and 118.6 ng/mL [IQR: 53.60-240.3]), than cholecystectomy (41.64 ng/mL [IQR: 11.17-90.93]) at the end of the surgical intervention. However, there were no differences between laparoscopic and open colectomy. Increased peritoneal protease release during surgery was observed in patients who developed POI after colectomy. CONCLUSIONS & INFERENCES Colorectal surgery causes protease release from peritoneal MCs. Protease release does not differ between both types of colectomy (laparoscopy vs laparotomy). However, MC activation is increased in colectomy patients developing POI. Therefore, degranulation of peritoneal MCs as a factor contributing to human POI after colectomy might be considered in future studies as a target to avoid POI.
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Affiliation(s)
- S Berdún
- Department of Cell Biology, Physiology and Immunology, Universitat Autònoma de Barcelona, Barcelona, Spain
| | - E Bombuy
- Department of Surgery, Consorci Sanitari del Maresme (CSdM) - Hospital de Mataró, Universitat Autònoma de Barcelona, Barcelona, Spain
| | - O Estrada
- Department of Surgery, Consorci Sanitari del Maresme (CSdM) - Hospital de Mataró, Universitat Autònoma de Barcelona, Barcelona, Spain
| | - E Mans
- Department of Surgery, Consorci Sanitari del Maresme (CSdM) - Hospital de Mataró, Universitat Autònoma de Barcelona, Barcelona, Spain
| | - J Rychter
- Department of Cell Biology, Physiology and Immunology, Universitat Autònoma de Barcelona, Barcelona, Spain.,Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Barcelona, Spain
| | - P Clavé
- Department of Surgery, Consorci Sanitari del Maresme (CSdM) - Hospital de Mataró, Universitat Autònoma de Barcelona, Barcelona, Spain.,Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Barcelona, Spain
| | - P Vergara
- Department of Cell Biology, Physiology and Immunology, Universitat Autònoma de Barcelona, Barcelona, Spain.,Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Barcelona, Spain
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Manger JP, Nelson M, Blanchard S, Helo S, Conaway M, Krupski TL. Alvimopan: A cost-effective tool to decrease cystectomy length of stay. Cent European J Urol 2014; 67:335-41. [PMID: 25667750 PMCID: PMC4310883 DOI: 10.5173/ceju.2014.04.art4] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2014] [Revised: 06/15/2014] [Accepted: 08/28/2014] [Indexed: 11/22/2022] Open
Abstract
INTRODUCTION We sought to evaluate the cost effectiveness of perioperative use of alvimopan in cystectomy and urinary diversion. A recent randomized controlled trial demonstrated the efficacy of alvimopan in reducing postoperative ileus and length of stay in cystectomy; however, a major limitation was the exclusion of epidural analgesia. MATERIALS AND METHODS Eighty-six cystectomy and urinary diversion procedures performed by seven surgeons were analyzed between January 2008 and April 2012. The first 50 patients did not receive alvimopan perioperatively, while the subsequent 36 received a single dose of 12 mg preoperatively and then 12 mg every 12 hours for 15 doses or until discharge. RESULTS The groups were equal with respect to age, gender, indication, surgeon, and type of diversion. Patients who received alvimopan experienced a shorter length of stay (LOS) versus those in who did not receive alvimopan (10.5 vs. 8.6 days, p = 0.005, 95% CI 0.6-3.3). Readmission for ileus was low in both alvimopan and control groups (0% and 4.4%, respectively). Costs were significantly lower in the alvimopan group than the control groups (2012 USD 32,443 vs. 40,604 p <0.001). This difference stood up to multivariate analysis with a $7,062 difference in hospital stay. CONCLUSIONS Use of alvimopan in the routine perioperative care of our cystectomy and urinary diversion patients has decreased LOS by 1.9 days. Additionally, institution of routine perioperative alvimopan has reduced costs by $7,062 per admission (20% reduction). This demonstrates a real world application of alvimopan at a moderate volume center.
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Affiliation(s)
| | - Marc Nelson
- University of Virginia, Department of Urology, Charlottesville, USA
| | | | - Sevann Helo
- Albany Medical Center, Division of Urology, Albany, USA
| | - Mark Conaway
- University of Virginia, Division of Biostatistics and Epidemiology, Charlottesville, USA
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Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis 2014; 29:1527-34. [PMID: 25331030 DOI: 10.1007/s00384-014-2030-8] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 10/09/2014] [Indexed: 02/04/2023]
Abstract
BACKGROUND Postoperative ileus is a significant clinical challenge lacking effective management strategies. Ghrelin-receptor stimulation has promotility effects in the upper and lower gastrointestinal tract. OBJECTIVE This proof-of-concept, phase 2, randomized study evaluated the safety and efficacy of the ghrelin-receptor agonist ipamorelin in the treatment of postoperative ileus following abdominal surgery (ClinicalTrials.gov NCT00672074). DESIGN The design was a multicenter, double-blind, placebo-controlled, clinical trial. SETTINGS The settings include hospital inpatients. PATIENTS The patients were adults undergoing small and large bowel resection by open or laparoscopic surgery. INTERVENTION The intervention was intravenous infusions of 0.03-mg/kg ipamorelin vs placebo twice daily, on postoperative day 1 to 7 or hospital discharge. MAIN OUTCOME MEASURES Safety was assessed by monitoring adverse events and laboratory tests. The key efficacy endpoint was time from first dose of study drug to tolerance of a standardized solid meal. RESULTS One hundred seventeen patients were enrolled, of whom 114 patients composed the safety and modified intent-to-treat populations. Demographic and disease characteristics were balanced between groups. Overall incidence of any treatment-emergent adverse events was 87.5 % in the ipamorelin group and 94.8 % in placebo group. Median time to first tolerated meal was 25.3 and 32.6 h in the ipamorelin and placebo groups, respectively (p = 0.15). LIMITATIONS This proof of concept study was small and enrolled patients with a broad range of underlying conditions. CONCLUSIONS Ipamorelin 0.03-mg/kg twice daily for up to 7 days was well tolerated. There were no significant differences between ipamorelin and placebo in the key and secondary efficacy analyses.
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Improving outcomes and cost-effectiveness of colorectal surgery. J Gastrointest Surg 2014; 18:1944-56. [PMID: 25205538 DOI: 10.1007/s11605-014-2643-9] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/13/2014] [Accepted: 08/25/2014] [Indexed: 02/08/2023]
Abstract
In order to truly make an impact on improving the cost effectiveness, and most importantly, the outcomes of patients undergoing colorectal surgery, all aspects of care need to be scrutinized, re-evaluated, and refined. To accomplish this, everything from the way we train surgeons to the adoption of a minimally invasive approach for colorectal disease, along with the use of adjunct intraoperative measures to decrease morbidity and mortality, may all need to be incorporated within an ERAS program. Only then will this approach lead the provider to a patient-centric care plan which can successfully reduce metrics such as morbidity, mortality, and length of stay (even with the obligatory readmission rate) and provide it all at a lower cost of care.
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Tobis S, Heinlen JE, Ruel N, Lau C, Kawachi M, Wilson T, Chan K. Effect of Alvimopan on Return of Bowel Function After Robot-Assisted Radical Cystectomy. J Laparoendosc Adv Surg Tech A 2014; 24:693-7. [DOI: 10.1089/lap.2014.0170] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022] Open
Affiliation(s)
- Scott Tobis
- City of Hope National Medical Center, Duarte, California
| | | | - Nora Ruel
- City of Hope National Medical Center, Duarte, California
| | - Clayton Lau
- City of Hope National Medical Center, Duarte, California
| | - Mark Kawachi
- City of Hope National Medical Center, Duarte, California
| | - Timothy Wilson
- City of Hope National Medical Center, Duarte, California
| | - Kevin Chan
- City of Hope National Medical Center, Duarte, California
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Simorov A, Thompson J, Oleynikov D. Alvimopan reduces length of stay and costs in patients undergoing segmental colonic resections: results from multicenter national administrative database. Am J Surg 2014; 208:919-25; discussion 925. [PMID: 25440479 DOI: 10.1016/j.amjsurg.2014.08.011] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/09/2014] [Revised: 08/18/2014] [Accepted: 08/20/2014] [Indexed: 11/25/2022]
Abstract
BACKGROUND Alvimopan (Entereg), a peripherally acting mu-opioid receptor antagonist, has been shown to expedite recovery of bowel function after colon resection surgery. Most data are available from industry-sponsored trials. This study aims to evaluate the clinical impact of this drug on perioperative outcomes and costs in patients undergoing segmental colonic resection for diverticular disease. METHODS A large administrative database maintained by the University Health System Consortium, an alliance of over 200 academic and affiliate hospitals, was queried from 2008 to 2011. International Classification of Diseases, 9th Revision, Clinical Modification codes for segmental colon resection because of diverticular disease were used to identify 2 matched cohorts of adult patients. University Health System Consortium's clinical resource manager was used to access pharmacy data and compare it with patient outcomes. RESULTS Five thousand two hundred ninety-nine patients met the above criteria. Four hundred thirty-eight patients received alvimopan and 4,861 did not. Regardless of laparoscopic or open approach, alvimopan significantly improved the postoperative length of stay (4.43 ± 2.02 vs 5.92 ± 3.79, P < .0001), cost (9,974 ± 4,077 vs 11,303 ± 6,968, P < .0001), and intensive care unit admission rate (1.83% vs 7.20%, P < .05), with no significant difference in mortality (.0% vs .19%, P = 1.000), morbidity (5.93% vs 8.39%, P = .08), or 30-day readmission rate (4.40% vs 4.63%, P = .90). CONCLUSIONS Alvimopan significantly reduced length of stay, days in the intensive care unit, and hospital cost for patients undergoing colonic segmental resections. Unlike some previously reported studies, we also observed a significant reduction in the length of stay in patients undergoing laparoscopic colectomies who received the drug. Alvimopan may reduce total healthcare costs if used as part of a best care practice model for colon resections.
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Affiliation(s)
- Anton Simorov
- Department of Surgery, University of Nebraska Medical Center, Omaha, NE, USA
| | - Jon Thompson
- Department of Surgery, University of Nebraska Medical Center, Omaha, NE, USA
| | - Dmitry Oleynikov
- Department of Surgery, University of Nebraska Medical Center, Omaha, NE, USA.
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Keller D, Stein SL. Facilitating return of bowel function after colorectal surgery: alvimopan and gum chewing. Clin Colon Rectal Surg 2014; 26:186-90. [PMID: 24436673 DOI: 10.1055/s-0033-1351137] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
Postoperative ileus is common after colorectal surgery, and has a huge impact on hospital LOS. With the impeding cost crisis in the United States, safely reducing length of stay is essential. Chewing gum and pharmacological treatment with alvimopan are safe, simple tools to reduce postoperative ileus and its associated costs. Future research will determine if integrating these tools with laparoscopic procedures and enhanced recovery pathways is a best practice in colorectal surgery.
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Affiliation(s)
- Deborah Keller
- Division of Colorectal Surgery, Department of Surgery, University Hospitals Case Medical Center, Cleveland, Ohio
| | - Sharon L Stein
- Division of Colorectal Surgery, Department of Surgery, University Hospitals Case Medical Center, Cleveland, Ohio
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Bauer VP. The Evidence against Prophylactic Nasogastric Intubation and Oral Restriction. Clin Colon Rectal Surg 2014; 26:182-5. [PMID: 24436672 DOI: 10.1055/s-0033-1351136] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
Evidence-based perioperative care plans after colorectal surgery serve to improve quality outcome, decrease complications, and reduce medical cost. The benefits of routine nasogastric decompression and prolonged enteral restriction after bowel resection are not supported in this new era of evidence-based surgical care. Prophylactic nasogastric decompression fails to improve bowel function, length of stay, and prevent anastomotic leak, wound complications (infection, fascial dehiscence, incisional hernia), pulmonary complications (atelectasis, aspiration, pneumonia, fever, pharyngolaryngitis), and abdominal discomfort (distension, nausea, vomiting). Patients have earlier return of bowel function without the use of a nasogastric tube (NGT). Early refeeding within 24 hours after bowel resection is well tolerated in 80 to 90% of patients, and associated with earlier hospital discharge, decreased risk of infection, and improved postoperative hyperglycemic control. Abdominal discomfort is the most common complication observed in patients treated with early feeding and without a NGT, but does not result in higher therapeutic nasogastric intubation, postoperative ileus, aspiration, or other complications. The use of multimodal adjuncts in combination with these guidelines should be considered to improve outcome. The current literature is reviewed with suggestions for achieving better outcomes after colorectal resection.
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Affiliation(s)
- Valerie P Bauer
- Department of Surgery, Baylor College of Medicine, Texas City, Texas
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Barletta JF, Senagore AJ. Reducing the Burden of Postoperative ileus: Evaluating and Implementing an Evidence-based Strategy. World J Surg 2014; 38:1966-77. [DOI: 10.1007/s00268-014-2506-2] [Citation(s) in RCA: 44] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
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Raju DP, Hakendorf P, Costa M, Wattchow DA. Efficacy and safety of low-dose celecoxib in reducing post-operative paralytic ileus after major abdominal surgery. ANZ J Surg 2013; 85:946-50. [PMID: 26780018 DOI: 10.1111/ans.12475] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/15/2013] [Indexed: 01/15/2023]
Abstract
BACKGROUND A number of interventions have been used to decrease the incidence of post-operative paralytic ileus. A secondary outcome of a randomized controlled study showed that COX-2 inhibitors decreased the incidence of paralytic ileus. We sought to study a large cohort of patients undergoing major abdominal operations who were treated with a COX-2 inhibitor. METHODS This is a retrospective review of prospectively collected data. All eligible patients were given a COX-2 inhibitor--celecoxib 100 mg--twice daily starting on the day of surgery until the seventh day post-operatively or discharge, whichever was earlier. The rate of paralytic ileus was calculated and compared with historical data. Secondary outcome measures were the effect of using COX-2 inhibitors on renal function, electrolytes and haemoglobin, morbidity and leak rates. RESULTS Two hundred and fifty-two patients were treated with celecoxib; the control arm consisted of 67 historical patients. Of the 252 patients, we had complete data for 235 patients and ileus in 17 patients (7.23%) compared with 13.4% in the control group (P = 0.05). Subgroup analysis showed ileus in 5.45% of colectomy patients and 6.36% of patients who have had a colectomy and high anterior resection. There was no detriment of measured blood tests. There were leaks in two treated patients, both of whom did not require a laparotomy. CONCLUSIONS The use of low-dose COX-2 inhibitor over a short period of time decreases the paralytic ileus rates and does not cause any significant morbidity.
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Affiliation(s)
- Devinder P Raju
- Department of Colorectal Surgery, Flinders Medical Center, Adelaide, South Australia, Australia
| | - Paul Hakendorf
- Department of Clinical Epidemiology, Flinders Medical Center, Adelaide, South Australia, Australia
| | - Marcello Costa
- Department of Human Physiology, Flinders University, Adelaide, South Australia, Australia
| | - David A Wattchow
- Department of Colorectal Surgery, Flinders Medical Center, Flinders Private Hospital, Flinders University, Adelaide, South Australia, Australia
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Affiliation(s)
- Jakub Rychter
- CIBERehd, Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas, Instituto de Salud Carlos III, , Barcelona, Catalonia, Spain
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Hui V, Hyman N, Viscomi C, Osler T. Implementing a fast-track protocol for patients undergoing bowel resection: not so fast. Am J Surg 2013; 206:152-8. [DOI: 10.1016/j.amjsurg.2012.11.019] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/16/2012] [Revised: 10/23/2012] [Accepted: 11/06/2012] [Indexed: 01/01/2023]
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Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O. Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(®)) Society recommendations. World J Surg 2013; 37:259-84. [PMID: 23052794 DOI: 10.1007/s00268-012-1772-0] [Citation(s) in RCA: 845] [Impact Index Per Article: 70.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
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