A Study of Surgical Interventions in Fistulizing Conditions

Fistula Clinical Trial

Official title:

SPOTLITE: Prospective Observational Study on the Clinical Outcomes of Surgical Interventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04940611
• Other study ID #: Alofisel-5007
• Status: Active, not recruiting
• Start date: August 5, 2021
• Est. completion date: May 2, 2026

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: May 2, 2026
• Est. primary completion date: May 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Complex Perianal Fistula
• Crohn Disease
• Crohns Disease
• Fistula
• Rectovaginal Fistula

Locations

Country	Name	City	State
Austria	AKH - Medizinische Universitat Wien	Vienna
Belgium	UZ Antwerpen	Antwerp
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Jessa Ziekenhuis Hospital	Hasselt
Belgium	Clinique CHC MontLegia	Liege
Belgium	AZ Delta	Roeselare
Canada	St. Pauls Hospital	Vancouver	British Columbia
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	NH Hospital a.s.Nemocnice Horovice	Horovice
Czechia	Fakultni nemocnice Olomouc	Olomouc
France	CHRU Hopital Claude Huriez	Lille	Nord
France	Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon	Paris
France	Hopital Saint Joseph - Paris	Paris
France	Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud	Pierre-Benite	Bouches-du-Rhone
France	CHU de Rennes - Hopital Pontchaillou	Rennes cedex 09	Ille Et Vilaine
France	CHU de Rouen - Hopital Charles Nicolle	Rouen Cedex	Seine Maritime
France	Fondation Maison Sante Bagatelle	Talence	Gironde
Israel	Shamir Medical Center (Assaf Harofeh)	Be'er Ya'aqov
Israel	Rambam Health Care Center	Haifa
Israel	Wolfson Medical Center	Holon
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Netherlands	Amsterdam UMC, Locatie AMC	Amsterdam
Netherlands	UMC Utrecht	Utrecht
United Kingdom	Broomfield Hospital	Chelmsford	Essex
United Kingdom	Royal Victoria Infirmary.	Newcastle upon Tyne	Tyne & Wear
United Kingdom	Nottingham University Hospital	Nottingham	Nottinghamshire
United States	GI Alliance - Baton Rouge	Baton Rouge	Louisiana
United States	UNC Hospitals	Chapel Hill	North Carolina
United States	Baylor Research Institute	Dallas	Texas
United States	Premier Health	Dayton	Ohio
United States	Colon & Rectal Clinic	Houston	Texas
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Vanderbilt University Medical Center- GI Endoscopy Lab	Nashville	Tennessee
United States	Lenox Hill Hospital PRIME	New York	New York
United States	Penn Medicine PA	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of South Florida - PARENT	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  France,  Israel,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants With Post-surgical Complications	Post-surgical complications for CPF-CD and CCF is defined as post-index surgery perianal pain, bleeding, infection, urinary retention, delayed or poor wound healing, anal stenosis, and fecal incontinence related to index surgery. Post-surgical complications for CD-RVF is defined as post-index surgery vaginal bleeding, infection, urinary retention, urinary tract infections (UTIs), discharge, delayed or poor wound healing, anal stenosis, fecal incontinence, and pain with intercourse or others related to index surgery.	Baseline, 3, 6, 12 and 24 months post-index surgery
Secondary	Percentage of Participants who Achieve Combined Remission	Combined remission for CPF-CD and CCF is defined as closure of all index external fistula openings treated with surgery that were draining at baseline as assessed clinically despite gentle finger compression, and absence of fluid collections greater than (>) 2 centimeter (cm) in at least 2 dimensions, as confirmed by pelvic magnetic resonance imaging (MRI) or other imaging procedure. Combined remission for CD-RVF is defined as 100 percent (%) cessation of drainage on both clinical exam with deep palpation (deeper bimanual exam/palpation with speculum and/or anoscope) and epithelization of the index external fistula opening (vaginal opening) compared to baseline; and absence of fluid collection as assessed by MRI or other imaging procedure.	Baseline, 3, 6, 12 and 24 months post-index surgery
Secondary	Percentage of Participants who Achieve Cessation of Drainage in Treated Fistula	Cessation of drainage for CPF-CD and CCF is defined as 100% cessation of drainage from index treated fistula, as assessed clinically. Cessation of drainage for CD-RVF is defined as 100% cessation of drainage on clinical exam with deep palpation (deeper bimanual exam/palpation with speculum and/or anoscope) from the index treated fistula.	Baseline, 3, 6, 12 and 24 months post-index surgery
Secondary	Percentage of Participants With Relapse of Fistula in Clinical Remission	Relapse for CPF-CD and CCF is defined as reopening of any surgically treated index fistulae as clinically assessed; or the development of a perianal fluid collection >2 cm in at least 2 dimensions of the perianal fistula(s) treated, confirmed by MRI assessment or other imaging procedure; or drainage. Relapse for CD-RVF is defined as reopening of any surgically treated index fistulae as clinically assessed; or appearance of fluid collection as assessed by MRI or other imaging procedure; or drainage.	Baseline, 3, 6, 12 and 24 months post-index surgery
Secondary	Percentage of Participants With New Perianal Abscess		Baseline, 3, 6, 12 and 24 months post-index surgery

External Links

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