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)
1 other identifier
observational
646
10 countries
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Typical duration for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedStudy Start
First participant enrolled
August 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedMay 1, 2026
April 1, 2026
3.7 years
June 18, 2021
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline up to 24 months
Secondary Outcomes (5)
Percentage of Participants With Post-surgical Complications
Baseline, 3, 6, 12 and 24 months post-index surgery
Percentage of Participants who Achieve Combined Remission
Baseline, 3, 6, 12 and 24 months post-index surgery
Percentage of Participants who Achieve Cessation of Drainage in Treated Fistula
Baseline, 3, 6, 12 and 24 months post-index surgery
Percentage of Participants With Relapse of Fistula in Clinical Remission
Baseline, 3, 6, 12 and 24 months post-index surgery
Percentage of Participants With New Perianal Abscess
Baseline, 3, 6, 12 and 24 months post-index surgery
Study Arms (3)
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.
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.
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.
Eligibility Criteria
Participants undergoing surgical interventions to treat fistulas (CPF-CD, CD-RVF and CCF) from surgical and GI specialty sites.
You may qualify if:
- 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
- \. 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
- +2 more criteria
You may not qualify if:
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (41)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
University of South Florida - PARENT
Tampa, Florida, 33612, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160, United States
GI Alliance - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Lenox Hill Hospital PRIME
New York, New York, 10075, United States
UNC Hospitals
Chapel Hill, North Carolina, 27599, United States
Premier Health
Dayton, Ohio, 45409, United States
Penn Medicine PA
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Vanderbilt University Medical Center- GI Endoscopy Lab
Nashville, Tennessee, 37212, United States
Baylor Research Institute
Dallas, Texas, 75204, United States
Colon & Rectal Clinic
Houston, Texas, 77030, United States
AKH - Medizinische Universitat Wien
Vienna, 1090, Austria
UZ Antwerpen
Antwerp, 2650, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Jessa Ziekenhuis Hospital
Hasselt, 3500, Belgium
Clinique CHC MontLegia
Liège, 4000, Belgium
AZ Delta
Roeselare, 8800, Belgium
St. Pauls Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
NH Hospital a.s.Nemocnice Horovice
Hořovice, 268 31, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, Bouches-du-Rhone, 69310, France
Fondation Maison Sante Bagatelle
Talence, Gironde, 33400, France
CHU de Rennes - Hopital Pontchaillou
Rennes, Ille Et Vilaine, 35000, France
CHRU Hopital Claude Huriez
Lille, Nord, 59037, France
CHU de Rouen - Hopital Charles Nicolle
Rouen, Seine Maritime, 76031, France
Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon
Paris, 75012, France
Hopital Saint Joseph - Paris
Paris, 75014, France
Shamir Medical Center (Assaf Harofeh)
Be’er Ya‘aqov, 7033001, Israel
Rambam Health Care Center
Haifa, 3109601, Israel
Wolfson Medical Center
Holon, 58100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ, Netherlands
UMC Utrecht
Utrecht, 3508 GA, Netherlands
Broomfield Hospital
Chelmsford, Essex, CM1 7ET, United Kingdom
Nottingham University Hospital
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
Royal Victoria Infirmary.
Newcastle upon Tyne, Tyne & Wear, NE1 4LP, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2021
First Posted
June 25, 2021
Study Start
August 5, 2021
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.