A Study of Surgical Interventions in Fistulizing Conditions
Completed
Conditions studied: Crohns Disease, Fistula, Rectovaginal Fistula, Complex Perianal Fistula, Complex Cryptoglandular Fistula
In brief
In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice. The aim of the study is to generate real-world evidence on standard of care for surgical interventions and related outcomes when treating complex fistulizing conditions. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
Key facts
- Study ID
- NCT04940611
- Run by
- Takeda
- People needed
- 646
- Starts
- 2021-08-05
- Expected to finish
- 2025-04-30
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants with CPF-CD
- CPF-CD that meets one or more of the following criteria:
- High inter-sphincteric, high trans-sphincteric, extra-sphincteric or supra-sphincteric fistula, or
- Presence of greater than or equal to (>=) 2 external openings, or
- Associated perianal abscess(es)
- Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
- Fistulotomy, fistula plug, fibrin glue, advancement flap (AF), ligation of inter-sphincteric fistula tract (LIFT), flap repair, fistulectomy, proctectomy, stem cell therapy, other; and seton for palliative purposes.
- Participants with CD-RVF: Rectovaginal fistula per physician diagnosis
- Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
- Fistulotomy, fistula plug, fibrin glue, AF, LIFT, flap repair, fistulectomy, proctectomy, stem cell therapy, gracilis muscle interposition/tissue grafts, martius procedure, abdominal procedures, other; and seton use for palliative purposes.
- Participants with CCF:
- Complex cryptoglandular fistula that meets one or more of the following criteria:
- Mid or high trans-sphincteric, or
- Anterior in women, or
- Horseshoe fistula
- Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
- Fistulotomy, fistula plug, fibrin glue, AF, LIFT, flap repair, fistulectomy, proctectomy, stem cell therapy, other; and seton use for palliative purposes
You may not qualify if…
- Participants who meet any below mentioned criterion among CPF-CD, CD-RVF, and CCF diagnosis will be excluded from the study.
- Current participation in interventional clinical trials.
- Has CPF-CD: fistula connection to bladder or another organ
- Has CCF: diagnosis of Inflammatory Bowel Disease (IBD), including Ulcerative Colitis, and Crohn's Disease (CD).
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
- University of South Florida - PARENT — Tampa, Florida, United States
- University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States
- GI Alliance - Baton Rouge — Baton Rouge, Louisiana, United States
- Lenox Hill Hospital PRIME — New York, New York, United States
- UNC Hospitals — Chapel Hill, North Carolina, United States
- Premier Health — Dayton, Ohio, United States
- Penn Medicine PA — Philadelphia, Pennsylvania, United States
- Temple University Hospital — Philadelphia, Pennsylvania, United States
- Vanderbilt University Medical Center- GI Endoscopy Lab — Nashville, Tennessee, United States
- Baylor Research Institute — Dallas, Texas, United States
- Colon & Rectal Clinic — Houston, Texas, United States
- AKH - Medizinische Universitat Wien — Vienna, Austria
- UZ Antwerpen — Antwerp, Belgium
- Cliniques Universitaires Saint-Luc — Brussels, Belgium
- Jessa Ziekenhuis Hospital — Hasselt, Belgium
- Clinique CHC MontLegia — Liège, Belgium
- AZ Delta — Roeselare, Belgium
- St. Pauls Hospital — Vancouver, British Columbia, Canada
- Fakultni nemocnice Brno — Brno, Czechia
- Fakultni nemocnice u sv. Anny v Brne — Brno, Czechia
- NH Hospital a.s.Nemocnice Horovice — Hořovice, Czechia
- Fakultni nemocnice Olomouc — Olomouc, Czechia
- Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud — Pierre-Bénite, Bouches-du-Rhone, France
Full record on ClinicalTrials.gov
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