A Study of Surgical Interventions in Fistulizing Conditions
- Conditions
- Complex Cryptoglandular FistulaComplex Perianal FistulaCrohns DiseaseFistulaRectovaginal Fistula
- Registration Number
- NCT04940611
- Lead Sponsor
- Takeda
- Brief Summary
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.
- Detailed Description
This is a non-interventional, prospective study of participants with complex fistulizing conditions (CPF-CD, CD develops CD-RVF and CCF) who are currently undergoing surgical intervention in the real world clinical setting.
The study will enroll approximately 750 participants. The data will be collected prospectively at the study sites and will be recorded into electronic data capture forms (EDCs). Participants will be enrolled to the following observational cohorts:
* Participants With CPF-CD
* Participants With CD-RVF
* Participants With CCF
This multi-center study will be conducted in the United States, Canada, Europe, and Israel. Participants undergoing surgical interventions to treat fistulas will be enrolled from surgical and gastrointestinal (GI) specialty sites. The overall duration of the study will be 24 months. Data will be collected at baseline with follow-up information collected approximately every 3 to 6 months.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 750
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
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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants who Achieve Clinical Remission of Fistula Baseline up to 24 months Clinical remission for Complex perianal fistula in Crohn's Disease (CPF-CD) and Complex Cryptoglandular Fistula (CCF) is defined as closure of all index treated external fistula openings that were draining at baseline as assessed clinically despite gentle finger compression. Clinical remission for Rectovaginal fistula with Crohn's Disease (CD-RVF) is defined as epithelization of the index external fistula opening (vaginal opening) compared to baseline.
- Secondary Outcome Measures
Name Time Method Percentage of Participants who Achieve Combined Remission Baseline, 3, 6, 12 and 24 months post-index surgery Combined remission for CPF-CD and CCF is defined as closure of all index external fistula openings treated with surgery that were draining at baseline as assessed clinically despite gentle finger compression, and absence of fluid collections greater than (\>) 2 centimeter (cm) in at least 2 dimensions, as confirmed by pelvic magnetic resonance imaging (MRI) or other imaging procedure. Combined remission for CD-RVF is defined as 100 percent (%) cessation of drainage on both clinical exam with deep palpation (deeper bimanual exam/palpation with speculum and/or anoscope) and epithelization of the index external fistula opening (vaginal opening) compared to baseline; and absence of fluid collection as assessed by MRI or other imaging procedure.
Percentage of Participants With Relapse of Fistula in Clinical Remission Baseline, 3, 6, 12 and 24 months post-index surgery Relapse for CPF-CD and CCF is defined as reopening of any surgically treated index fistulae as clinically assessed; or the development of a perianal fluid collection \>2 cm in at least 2 dimensions of the perianal fistula(s) treated, confirmed by MRI assessment or other imaging procedure; or drainage. Relapse for CD-RVF is defined as reopening of any surgically treated index fistulae as clinically assessed; or appearance of fluid collection as assessed by MRI or other imaging procedure; or drainage.
Percentage of Participants who Achieve Cessation of Drainage in Treated Fistula Baseline, 3, 6, 12 and 24 months post-index surgery Cessation of drainage for CPF-CD and CCF is defined as 100% cessation of drainage from index treated fistula, as assessed clinically. Cessation of drainage for CD-RVF is defined as 100% cessation of drainage on clinical exam with deep palpation (deeper bimanual exam/palpation with speculum and/or anoscope) from the index treated fistula.
Percentage of Participants With Post-surgical Complications Baseline, 3, 6, 12 and 24 months post-index surgery Post-surgical complications for CPF-CD and CCF is defined as post-index surgery perianal pain, bleeding, infection, urinary retention, delayed or poor wound healing, anal stenosis, and fecal incontinence related to index surgery. Post-surgical complications for CD-RVF is defined as post-index surgery vaginal bleeding, infection, urinary retention, urinary tract infections (UTIs), discharge, delayed or poor wound healing, anal stenosis, fecal incontinence, and pain with intercourse or others related to index surgery.
Percentage of Participants With New Perianal Abscess Baseline, 3, 6, 12 and 24 months post-index surgery
Trial Locations
- Locations (41)
CHU de Rouen - Hopital Charles Nicolle
🇫🇷Rouen Cedex, Seine Maritime, France
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Broomfield Hospital
🇬🇧Chelmsford, Essex, United Kingdom
Penn Medicine PA
🇺🇸Philadelphia, Pennsylvania, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Vanderbilt University Medical Center- GI Endoscopy Lab
🇺🇸Nashville, Tennessee, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
CHRU Hopital Claude Huriez
🇫🇷Lille, Nord, France
Nottingham University Hospital
🇬🇧Nottingham, Nottinghamshire, United Kingdom
St. Pauls Hospital
🇨🇦Vancouver, British Columbia, Canada
AKH - Medizinische Universitat Wien
🇦🇹Vienna, Austria
University of South Florida - PARENT
🇺🇸Tampa, Florida, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
University of Kansas Medical Center Research Institute, Inc.
🇺🇸Kansas City, Kansas, United States
Lenox Hill Hospital PRIME
🇺🇸New York, New York, United States
Premier Health
🇺🇸Dayton, Ohio, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Colon & Rectal Clinic
🇺🇸Houston, Texas, United States
UZ Antwerpen
🇧🇪Antwerp, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Clinique CHC MontLegia
🇧🇪Liege, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
Jessa Ziekenhuis Hospital
🇧🇪Hasselt, Belgium
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
🇫🇷Pierre-Benite, Bouches-du-Rhone, France
NH Hospital a.s.Nemocnice Horovice
🇨🇿Horovice, Czechia
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
CHU de Rennes - Hopital Pontchaillou
🇫🇷Rennes cedex 09, Ille Et Vilaine, France
Fondation Maison Sante Bagatelle
🇫🇷Talence, Gironde, France
Wolfson Medical Center
🇮🇱Holon, Israel
Rambam Health Care Center
🇮🇱Haifa, Israel
Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon
🇫🇷Paris, France
Hopital Saint Joseph - Paris
🇫🇷Paris, France
Shamir Medical Center (Assaf Harofeh)
🇮🇱Be'er Ya'aqov, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Amsterdam UMC, Locatie AMC
🇳🇱Amsterdam, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Royal Victoria Infirmary.
🇬🇧Newcastle upon Tyne, Tyne & Wear, United Kingdom
GI Alliance - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
UNC Hospitals
🇺🇸Chapel Hill, North Carolina, United States