A Study of Surgical Interventions in Fistulizing Conditions
NCT ID: NCT04940611
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
750 participants
OBSERVATIONAL
2021-08-05
2026-05-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SuperSeton Pilot Studie
NCT03654482
Ligation of Intersphincteric Fistula Tract (LIFT) Procedure Versus Use of an Anal Fistula Plug for Anal Fistula Repair
NCT00830661
Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection
NCT04750499
Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
NCT01612195
Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula
NCT01602081
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants With CPF-CD
Participants diagnosed with CPF-CD will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.
No interventions assigned to this group
Participants With CD-RVF
Participants diagnosed with CD-RVF will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.
No interventions assigned to this group
Participants With CCF
Participants diagnosed with CCF will undergo surgical intervention according to their clinic's standard practice to treat the index fistula, and will be observed prospectively for 24 months post-index surgery.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Fondation Maison Sante Bagatelle
Talence, Gironde, France
CHU de Rennes - Hopital Pontchaillou
Rennes, Ille Et Vilaine, France
CHRU Hopital Claude Huriez
Lille, Nord, France
CHU de Rouen - Hopital Charles Nicolle
Rouen, Seine Maritime, France
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
Rambam Health Care Center
Haifa, , Israel
Wolfson Medical Center
Holon, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Amsterdam UMC, Locatie AMC
Amsterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Broomfield Hospital
Chelmsford, Essex, United Kingdom
Nottingham University Hospital
Nottingham, Nottinghamshire, United Kingdom
Royal Victoria Infirmary.
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain more information about this study, click this link.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Alofisel-5007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.