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Real-World surgery study aims to improve fistula care

NCT ID NCT04940611

Knowledge-focused Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tracked 646 people with complex fistulas (abnormal tunnels) caused by Crohn's disease or other conditions. Researchers observed the standard surgical treatments patients received at their clinics and recorded outcomes like fistula closure and complications. The goal is to gather real-world evidence on what works best in everyday practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors understand which surgical approaches work best for complex fistulas, potentially improving future treatment guidelines.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove which surgery is best. Results may vary across clinics and patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

646 people

The number who actually took part.

Started

Aug 2021

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants undergoing surgical interventions to treat fistulas (CPF-CD, CD-RVF and CCF) from surgical and GI specialty sites.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

anal fistula Crohn disease Fistula Rectovaginal Fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complex cryptoglandular fistula Complex perianal fistula Crohns disease Fistula Rectovaginal fistula

Contacts and locations

Locations

  • AKH - Medizinische Universitat Wien

    Vienna, 1090, Austria

  • AZ Delta

    Roeselare, 8800, Belgium

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ, Netherlands

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Baylor Research Institute

    Dallas, Texas, 75204, United States

  • Broomfield Hospital

    Chelmsford, Essex, CM1 7ET, United Kingdom

  • CHRU Hopital Claude Huriez

    Lille, Nord, 59037, France

  • CHU de Rennes - Hopital Pontchaillou

    Rennes, Ille Et Vilaine, 35000, France

  • CHU de Rouen - Hopital Charles Nicolle

    Rouen, Seine Maritime, 76031, France

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Clinique CHC MontLegia

    Liège, 4000, Belgium

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Colon & Rectal Clinic

    Houston, Texas, 77030, United States

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91, Czechia

  • Fondation Maison Sante Bagatelle

    Talence, Gironde, 33400, France

  • GI Alliance - Baton Rouge

    Baton Rouge, Louisiana, 70809, United States

  • Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon

    Paris, 75012, France

  • Hopital Saint Joseph - Paris

    Paris, 75014, France

  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Bouches-du-Rhone, 69310, France

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089, Italy

  • Jessa Ziekenhuis Hospital

    Hasselt, 3500, Belgium

  • Lenox Hill Hospital PRIME

    New York, New York, 10075, United States

  • NH Hospital a.s.Nemocnice Horovice

    Hořovice, 268 31, Czechia

  • Nottingham University Hospital

    Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

  • Penn Medicine PA

    Philadelphia, Pennsylvania, 19104, United States

  • Premier Health

    Dayton, Ohio, 45409, United States

  • Rambam Health Care Center

    Haifa, 3109601, Israel

  • Royal Victoria Infirmary.

    Newcastle upon Tyne, Tyne & Wear, NE1 4LP, United Kingdom

  • Shamir Medical Center (Assaf Harofeh)

    Be’er Ya‘aqov, 7033001, Israel

  • St. Pauls Hospital

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • UMC Utrecht

    Utrecht, 3508 GA, Netherlands

  • UNC Hospitals

    Chapel Hill, North Carolina, 27599, United States

  • UZ Antwerpen

    Antwerp, 2650, Belgium

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160, United States

  • University of South Florida - PARENT

    Tampa, Florida, 33612, United States

  • Vanderbilt University Medical Center- GI Endoscopy Lab

    Nashville, Tennessee, 37212, United States

  • Wolfson Medical Center

    Holon, 58100, Israel

More trials for these conditions

Other studies related to the condition(s) this trial covers.