Clinical trial NCT04940611: A Study of Surgical Interventions in Fistulizing Conditions
Official title: SPOTLITE: Prospective Observational Study on the Clinical Outcomes of Surgical Interventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohns Disease
Fistula
Rectovaginal Fistula
Complex Perianal Fistula
Complex Cryptoglandular Fistula
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-06-25
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants undergoing surgical interventions to treat fistulas (CPF-CD, CD-RVF and CCF) from surgical and GI specialty sites.

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.

Detailed description: This is a non-interventional, prospective study of participants with complex fistulizing conditions (CPF-CD, CD develops CD-RVF and CCF) who are currently undergoing surgical intervention in the real world clinical setting.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants who Achieve Clinical Remission of Fistula
timeFrame: Baseline up to 24 months
Secondary outcomes:
measure: Percentage of Participants With Post-surgical Complications
timeFrame: Baseline, 3, 6, 12 and 24 months post-index surgery
measure: Percentage of Participants who Achieve Combined Remission
timeFrame: Baseline, 3, 6, 12 and 24 months post-index surgery
measure: Percentage of Participants who Achieve Cessation of Drainage in Treated Fistula
timeFrame: Baseline, 3, 6, 12 and 24 months post-index surgery
measure: Percentage of Participants With Relapse of Fistula in Clinical Remission
timeFrame: Baseline, 3, 6, 12 and 24 months post-index surgery
measure: Percentage of Participants With New Perianal Abscess
timeFrame: Baseline, 3, 6, 12 and 24 months post-index surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida - PARENT
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Baton Rouge
country: United States
facility: GI Alliance - Baton Rouge
state: Louisiana
city: New York
country: United States
facility: Lenox Hill Hospital PRIME
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Dayton
country: United States
facility: Premier Health
state: Ohio
city: Philadelphia
country: United States
facility: Penn Medicine PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center- GI Endoscopy Lab
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: Colon & Rectal Clinic
state: Texas
city: Vienna
country: Austria
facility: AKH - Medizinische Universitat Wien
city: Antwerp
country: Belgium
facility: UZ Antwerpen
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis Hospital
city: Liege
country: Belgium
facility: Clinique CHC MontLegia
city: Roeselare
country: Belgium
facility: AZ Delta
city: Vancouver
country: Canada
facility: St. Pauls Hospital
state: British Columbia
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Horovice
country: Czechia
facility: NH Hospital a.s.Nemocnice Horovice
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Pierre-Benite
country: France
facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
state: Bouches-du-Rhone
city: Talence
country: France
facility: Fondation Maison Sante Bagatelle
state: Gironde
city: Rennes cedex 09
country: France
facility: CHU de Rennes - Hopital Pontchaillou
state: Ille Et Vilaine
city: Lille
country: France
facility: CHRU Hopital Claude Huriez
state: Nord
city: Rouen Cedex
country: France
facility: CHU de Rouen - Hopital Charles Nicolle
state: Seine Maritime
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon
city: Paris
country: France
facility: Hopital Saint Joseph - Paris
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
city: Haifa
country: Israel
facility: Rambam Health Care Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Locatie AMC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
state: Essex
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
state: Nottinghamshire
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary.
state: Tyne & Wear
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: