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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
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

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AKH - Medizinische Universitat Wien
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ViennaAustriaUnknown status
UZ Antwerpen
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AntwerpBelgiumUnknown status
Cliniques universitaires Saint-Luc
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BrusselsBelgiumUnknown status
Jessa Ziekenhuis Hospital
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HasseltBelgiumUnknown status
Clinique CHC MontLégia
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LiègeBelgiumUnknown status
AZ Delta
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RoeselareBelgiumUnknown status
St Pauls Hospital
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VancouverCanadaUnknown status
Fakultni nemocnice u sv. Anny v Brne
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BrnoCzechiaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaUnknown status
NH Hospital a.s.Nemocnice Horovice
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HořoviceCzechiaUnknown status
Fakultni nemocnice Olomouc
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OlomoucCzechiaUnknown status
CHRU, Hôpital Claude Huriez
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LilleFranceUnknown status
Hopital Saint Joseph - Paris
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ParisFranceUnknown status
Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon
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ParisFranceUnknown status
Hospices Civils De Lyon (hcl) -Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
CHU de Rennes - Hôpital Pontchaillou
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RennesFranceUnknown status
CHU de Rouen - Hôpital Charles Nicolle
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RouenFranceUnknown status
Fondation Maison Sante Bagatelle
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TalenceFranceUnknown status
Broomfield Hospital
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ChelmsfordUnited KingdomUnknown status
Royal Victoria Infirmary
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Newcastle upon TyneUnited KingdomUnknown status
Nottingham University Hospital
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NottinghamUnited KingdomUnknown status
Shamir Medical Center Assaf Harofeh
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Be’er Ya‘aqovIsraelUnknown status
Rambam Health Care Center
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HaifaIsraelUnknown status
Wolfson Medical Center
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HolonIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Istituto Clinico Humanitas
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RozzanoItalyUnknown status
Amsterdam UMC, locatie AMC
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AmsterdamNetherlandsUnknown status
UMC Utrecht
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UtrechtNetherlandsUnknown status
GI Alliance - Baton Rouge
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Baton RougeUnited StatesUnknown status
UNC Hospitals
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Chapel HillUnited StatesUnknown status
Baylor Research Institute
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DallasUnited StatesUnknown status
Premier Health
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DaytonUnited StatesUnknown status
Colon & Rectal Clinic
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HoustonUnited StatesUnknown status
Baptist MD Anderson Cancer Center
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JacksonvilleUnited StatesUnknown status
University of Kansas Medical Center Research Institute, Inc
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Kansas CityUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Vanderbilt University Medical Center- GI Endoscopy Lab
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NashvilleUnited StatesUnknown status
Lenox Hill Hospital PRIME
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New YorkUnited StatesUnknown status
Temple University Hospital
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PhiladelphiaUnited StatesUnknown status
Penn Medicine PA
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PhiladelphiaUnited StatesUnknown status
University of South Florida - PARENT
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TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.