1
|
McCurdy J, Munir J, Parlow S, Sambhi G, Reid J, Yanofsky R, Alenezi T, Meserve J, Yeh KH, Becker B, Lahijanian Z, Eddin AH, Mallick R, Ramsay T, Rosenfeld G, Bessissow A, Bessissow T, Jairath V, Bruining DH, Macdonald B, Singh S. The Impact of Setons on Perianal Fistula Outcomes in Patients With Crohn's Disease Treated With Anti-TNF Therapy: A Multicentre Study. Aliment Pharmacol Ther 2025; 61:1671-1679. [PMID: 40098436 DOI: 10.1111/apt.70081] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2025] [Revised: 02/21/2025] [Accepted: 03/03/2025] [Indexed: 03/19/2025]
Abstract
BACKGROUND AND AIMS We aimed to assess the impact of setons on perianal fistula outcomes in patients with perianal fistulising Crohn's disease (PFCD) treated with anti-TNF therapy. METHODS We included patients treated with their first anti-TNF therapy for PFCD after undergoing a pelvic MRI between 2005 and 2022 from 6 North American centres. Our exposure was one or more setons at the time of anti-TNF therapy. Our primary outcome was major adverse fistula outcome (MAFO), a composite of repeat local surgical intervention, hospitalisation, or faecal diversion for PFCD, and our secondary outcome was fistula remission defined clinically. We used 1:1 cardinality matching and propensity score weighting to control for fistula severity based on centrally read MRIs, luminal characteristics, and concomitant therapies. RESULTS Our analysis included 221 patients: 81 with setons and 140 without setons. After cardinality matching, our cohorts were balanced (standardised difference < 0.1 for all covariates). Patients with setons had similar rates of MAFO (HR 1.23; 95% CI, 0.68-2.21) and fistula remission at 6 months (OR, 0.81; 95% CI, 0.41-1.59) and 12 months (OR, 0.63; 95% CI, 0.31-1.27) compared to patients without setons. Our results remained stable when analysed by propensity score weighting and in a sensitivity analysis of patients who underwent an exam under anaesthesia. In patients with abscesses, there were lower rates of MAFO (HR, 0.49; 95% CI, 0.19-1.25) but not statistically significant in patients with setons. CONCLUSIONS In this multicentre, setons were not associated with improved fistula outcomes. Future prospective controlled studies are warranted.
Collapse
Affiliation(s)
- Jeffrey McCurdy
- Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
- Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada
| | - Javeria Munir
- Division of Diagnostic Imaging, The Ottawa Hospital, Ottawa, Ontario, Canada
| | - Simon Parlow
- Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Gagan Sambhi
- Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Jacqueline Reid
- Department of Medicine, UBC, Vancouver, British Columbia, Canada
| | - Russell Yanofsky
- Division of Gastroenterology and Hepatology, Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada
| | - Talal Alenezi
- Division of Gastroenterology and Hepatology, Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada
| | - Joseph Meserve
- Division of Gastroenterology, Department of Medicine, University of California San Diego, San Diego, California, USA
| | - Kuan-Hung Yeh
- Division of Gastroenterology, Department of Medicine, University of California San Diego, San Diego, California, USA
| | - Brenda Becker
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Zubin Lahijanian
- Division of Diagnostic Imaging, McGill University, Montreal, Quebec, Canada
| | - Anas Hussam Eddin
- Department of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada
| | - Ranjeeta Mallick
- Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada
| | - Tim Ramsay
- Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada
| | - Greg Rosenfeld
- Department of Medicine, UBC, Vancouver, British Columbia, Canada
| | - Ali Bessissow
- Division of Diagnostic Imaging, McGill University, Montreal, Quebec, Canada
| | - Talat Bessissow
- Division of Gastroenterology and Hepatology, Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada
| | - Vipul Jairath
- Department of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada
| | - David H Bruining
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Blair Macdonald
- Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada
- Division of Diagnostic Imaging, The Ottawa Hospital, Ottawa, Ontario, Canada
| | - Siddharth Singh
- Division of Gastroenterology, Department of Medicine, University of California San Diego, San Diego, California, USA
| |
Collapse
|
2
|
White I, Karki C, Geransar P, Leisle L, Junker S, Fleshner P. Impact of Seton Use on Clinical, Patient-Reported, and Healthcare Resource Utilization Outcomes in Complex Crohn's Perianal Fistulas: A Systematic Literature Review. Inflamm Bowel Dis 2024:izae186. [PMID: 39298676 DOI: 10.1093/ibd/izae186] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/31/2024] [Indexed: 09/22/2024]
Abstract
BACKGROUND Optimal treatment strategies for seton use in patients with Crohn's perianal fistulas (CPF) remain elusive. This systematic literature review aimed to summarize clinical, patient-reported, and healthcare resource utilization (HCRU) outcomes associated with seton use for symptomatic relief and treatment of complex CPF. METHODS Electronic databases (MEDLINE, Embase, EBM Reviews, EconLit) were searched. Titles, abstracts, and relevant full texts were screened by 2 reviewers for inclusion using prespecified PICOS-T criteria. Articles published in English between January 1, 1980 and September 6, 2021 were included; animal/in vitro studies and case reports with <5 patients were excluded. Outcomes of interest included rates of complete response/remission and fistula recurrence in patients receiving seton with/without infliximab or biologics. Data were summarized using descriptive statistics. RESULTS Overall, 56 studies were included (full texts: n = 43; congress abstracts: n = 13). CPF and clinical outcome definitions were heterogeneous. Rates (range) of complete response/remission varied widely (seton: 13%-75%; seton + infliximab: 23%-100%; seton + biologics: 23%-59%) as did rates for fistula recurrence (seton: 4%-68%; seton + infliximab: 0%-50%; seton + biologics: 0%-17%). Rates of fistula-related reintervention, new fistula or abscess formation, and abscess recurrence were also varied; more consistency was observed regarding the use of patient-reported outcomes. Few studies reported outcomes from pediatric/adolescent patients or HCRU. CONCLUSIONS Optimal use of seton in patients with CPF remains unclear. International standardization of definitions for CPF and related clinical outcomes are required to permit data comparability and identify the most effective treatment strategies involving seton use in CPF.
Collapse
Affiliation(s)
- Ian White
- Department of Surgery, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Chitra Karki
- Takeda Pharmaceuticals USA, Inc., Cambridge, MA, USA
| | - Parnia Geransar
- Takeda Pharmaceuticals International AG, Zurich, Switzerland
| | - Lilia Leisle
- Ingress-Health HWM GmbH, an affiliate of Cytel, Inc., Real World & Advanced Analytics, Berlin, Germany
| | - Sophia Junker
- Ingress-Health HWM GmbH, an affiliate of Cytel, Inc., Real World & Advanced Analytics, Berlin, Germany
| | - Phillip Fleshner
- Cedars-Sinai Medical Center, Division of Colon and Rectal Surgery, Los Angeles, CA, USA
| |
Collapse
|
3
|
Gadepalli SK, Adler J. Perianal disease: Updates and controversies in closing the gaps. Semin Pediatr Surg 2024; 33:151402. [PMID: 38603820 DOI: 10.1016/j.sempedsurg.2024.151402] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/13/2024]
Abstract
Perianal complications are common and morbid in children with Crohn's disease. In this review, we describe the epidemiology, the presentation and diagnosis, evaluation and management. We focus on updates such as the increasing frequency of biologic medications and MRI for evaluation. We also highlight controversies on the timing and approaches to surgical techniques. Finally, perianal disease requires the coordination of multidisciplinary care with nursing, radiology, gastroenterology, and surgery to optimize outcomes - both medical and patient-centered.
Collapse
Affiliation(s)
- Samir K Gadepalli
- Section of Pediatric Surgery, Department of Surgery, University of Michigan, Ann Arbor, MI, United States; Susan G. Meister CHEAR Center, University of Michigan, Ann Arbor, MI, United States.
| | - Jeremy Adler
- Susan G. Meister CHEAR Center, University of Michigan, Ann Arbor, MI, United States; Division of Pediatric Gastroenterology, Department of Pediatrics, University of Michigan, Ann Arbor, MI, United States
| |
Collapse
|
4
|
Wetwittayakhlang P, Al Khoury A, Hahn GD, Lakatos PL. The Optimal Management of Fistulizing Crohn's Disease: Evidence beyond Randomized Clinical Trials. J Clin Med 2022; 11:3045. [PMID: 35683433 PMCID: PMC9181669 DOI: 10.3390/jcm11113045] [Citation(s) in RCA: 14] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/11/2022] [Revised: 05/21/2022] [Accepted: 05/25/2022] [Indexed: 02/04/2023] Open
Abstract
Fistulizing Crohn's disease (FCD) remains the most challenging aspect of treating patients with CD. FCD can occur in up to 30% of patients with CD and may lead to significant disability and impaired quality of life. The optimal treatment strategies for FCD require a multidisciplinary approach, including a combined medical and surgical approach. The therapeutic options for FCD are limited due to sparse evidence from randomized clinical trials (RCTs). The current recommendations are mainly based on post hoc analysis from RCTs, real-world clinical studies and expert opinion. There is variation in everyday clinical practice amongst gastroenterologists and surgeons. The evidence for anti-tumor necrosis factor therapy is the strongest in the treatment of FCD. However, long-term fistula healing can be achieved in only 30-50% of patients. In recent years, emerging data in the advent of therapeutic modalities, including the use of new biologic agents, therapeutic drug monitoring, novel surgical methods and mesenchymal stem cell therapy, have been shown to improve outcomes in achieving fistula healing. This review summarizes the existing literature on current and emerging therapies to provide guidance beyond RCTs in managing FCD.
Collapse
Affiliation(s)
- Panu Wetwittayakhlang
- Division of Gastroenterology, McGill University Health Center, Montreal, QC H3G 1A4, Canada or (P.W.); (G.D.H.)
- Gastroenterology and Hepatology Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla 90110, Thailand
| | - Alex Al Khoury
- Division of Gastroenterology, University of Florida, Jacksonville, FL 32209, USA;
| | - Gustavo Drügg Hahn
- Division of Gastroenterology, McGill University Health Center, Montreal, QC H3G 1A4, Canada or (P.W.); (G.D.H.)
- Graduate Course Sciences in Gastroenterology and Hepatology, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre 90035-002, Brazil
| | - Peter Laszlo Lakatos
- Division of Gastroenterology, McGill University Health Center, Montreal, QC H3G 1A4, Canada or (P.W.); (G.D.H.)
- First Department of Medicine, Semmelweis University, 1085 Budapest, Hungary
| |
Collapse
|
5
|
Angriman I, Tomassi M, Ruffolo C, Bordignon G, Saadeh L, Gruppo M, Pucciarelli S, Bardini R, Scarpa M. Impact on Quality of Life of Seton Placing in Perianal Crohn's Disease. Front Surg 2022; 8:806497. [PMID: 35141271 PMCID: PMC8818691 DOI: 10.3389/fsurg.2021.806497] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/31/2021] [Accepted: 12/20/2021] [Indexed: 11/13/2022] Open
Abstract
IntroductionOften, in perineal Crohn's disease (CD), a seton is placed to guarantee a constant drainage and prevent septic complication while biologic therapy is ongoing. This study aimed to assess the long-term quality of life after surgery for perineal CD in relation to seton placing.Patients and MethodsData of 65 consecutive patients with CD and non-CD operated on from 2014 to 2019 for perianal fistula or abscess were retrieved. Forty-three had CD and 14 of them had a seton placed during surgery and they kept it on while they had anti-TNF-alpha therapy. Patients were interviewed with the Cleveland Global Quality of Life (CGQL) and SF-12 quality of life questionnaires. Disease activity was defined as Harvey-Bradshaw Index (HBI) and Perianal Disease Activity Index (PDAI). Comparisons between groups were carried out with the nonparametric tests, and multiple regression models were used to assess predictors of quality of life.ResultsThe total CGQL score and SF-12 mental component score (MCS) were significantly higher (and thus better) in the seton group than in patients treated without seton. On the contrary, SF-12 physical component score (PCS) was not different between the two groups. HBI was significantly better in patients in the seton group. At multivariate analysis, seton placement and HBI were confirmed to be independent predictors of long-term SF-12 MCS whereas only HBI confirmed to be a predictor of total CGQL score.ConclusionsSeton placing during anti-TNF-alpha therapy is independently associated with a better MCS. Unexpectedly, this device, instead of to cause psychological distress, seems to assure patients during their biologic therapy providing psychological benefit beyond the mere medical effect.
Collapse
Affiliation(s)
- Imerio Angriman
- Chirurgia Generale III, Department of Surgical Oncological and Gastroenterological Sciences, Azienda Ospedale Università di Padova, Padua, Italy
- General Surgery Unit, Azienda Ospedale Università di Padova, Padua, Italy
- *Correspondence: Imerio Angriman
| | - Monica Tomassi
- Chirurgia Generale III, Department of Surgical Oncological and Gastroenterological Sciences, Azienda Ospedale Università di Padova, Padua, Italy
- General Surgery Unit, Azienda Ospedale Università di Padova, Padua, Italy
| | - Cesare Ruffolo
- Chirurgia Generale III, Department of Surgical Oncological and Gastroenterological Sciences, Azienda Ospedale Università di Padova, Padua, Italy
- General Surgery Unit, Azienda Ospedale Università di Padova, Padua, Italy
| | - Giovanni Bordignon
- General Surgery Unit, Azienda Ospedale Università di Padova, Padua, Italy
| | - Luca Saadeh
- General Surgery Unit, Azienda Ospedale Università di Padova, Padua, Italy
| | - Mario Gruppo
- General Surgery Unit, Azienda Ospedale Università di Padova, Padua, Italy
- Surgical Oncology Unit, Veneto Institute of Oncology IOV Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Castelfranco Veneto, Italy
| | - Salvatore Pucciarelli
- Chirurgia Generale III, Department of Surgical Oncological and Gastroenterological Sciences, Azienda Ospedale Università di Padova, Padua, Italy
| | - Romeo Bardini
- General Surgery Unit, Azienda Ospedale Università di Padova, Padua, Italy
| | - Marco Scarpa
- Chirurgia Generale III, Department of Surgical Oncological and Gastroenterological Sciences, Azienda Ospedale Università di Padova, Padua, Italy
- General Surgery Unit, Azienda Ospedale Università di Padova, Padua, Italy
| |
Collapse
|