A Study of Surgical Interventions in Fistulizing Conditions

N/AActive Not RecruitingNCT04940611

Takeda750 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

750

Conditions

Crohns Disease Fistula Rectovaginal Fistula Complex Perianal Fistula

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Participants with CPF-CD 1. 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) 2. 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 1\. 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: 1. Complex cryptoglandular fistula that meets one or more of the following criteria: * Mid or high trans-sphincteric, or * Anterior in women, or * Horseshoe fistula 2. 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 Exclusion Criteria: Participants who meet any below mentioned criterion among CPF-CD, CD-RVF, and CCF diagnosis will be excluded from the study. 1. Current participation in interventional clinical trials. 2. Has CPF-CD: fistula connection to bladder or another organ 3. Has CCF: diagnosis of Inflammatory Bowel Disease (IBD), including Ulcerative Colitis, and Crohn's Disease (CD).

Locations (41)

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

Outcomes

Primary Outcomes

Percentage of Participants who Achieve Clinical Remission of Fistula

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.

Time frame: Baseline up to 24 months

Secondary Outcomes

Percentage of Participants With Post-surgical Complications

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.