NCT04940611Completed
A Study of Surgical Interventions in Fistulizing Conditions
SPOTLITE: Prospective Observational Study on the Clinical Outcomes of Surgical Interventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 646 (actual)
- First submitted
- 18 Jun 2021
- Start date
- 5 Aug 2021
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease
- NCT number
- NCT04940611
What you commit to
- Study type: Observational
- Participants enrolled: 646
- From 5 Aug 2021 to the primary completion date, 30 Apr 2025
- 41 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 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
- 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:
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AKH - Medizinische Universitat Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| UZ Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Jessa Ziekenhuis Hospital Coordinator of this site? Confirm its status | Hasselt | Belgium | Unknown status |
| Clinique CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
| St Pauls Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Fakultni nemocnice u sv. Anny v Brne Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| NH Hospital a.s.Nemocnice Horovice Coordinator of this site? Confirm its status | Hořovice | Czechia | Unknown status |
| Fakultni nemocnice Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| CHRU, Hôpital Claude Huriez Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hopital Saint Joseph - Paris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hospices Civils De Lyon (hcl) -Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| CHU de Rennes - Hôpital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHU de Rouen - Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Fondation Maison Sante Bagatelle Coordinator of this site? Confirm its status | Talence | France | Unknown status |
| Broomfield Hospital Coordinator of this site? Confirm its status | Chelmsford | United Kingdom | Unknown status |
| Royal Victoria Infirmary Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Nottingham University Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Shamir Medical Center Assaf Harofeh Coordinator of this site? Confirm its status | Be’er Ya‘aqov | Israel | Unknown status |
| Rambam Health Care Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Wolfson Medical Center Coordinator of this site? Confirm its status | Holon | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
| Amsterdam UMC, locatie AMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| GI Alliance - Baton Rouge Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| UNC Hospitals Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Baylor Research Institute Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Premier Health Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Colon & Rectal Clinic Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Baptist MD Anderson Cancer Center Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| University of Kansas Medical Center Research Institute, Inc Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Vanderbilt University Medical Center- GI Endoscopy Lab Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Lenox Hill Hospital PRIME Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Temple University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Penn Medicine PA Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of South Florida - PARENT Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.