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)

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.

Study Overview

• Status: Recruiting
• Conditions: Fistula; Crohns Disease; Rectovaginal Fistula; Complex Perianal Fistula; Complex Cryptoglandular Fistula

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.

• Study Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • AKH - Medizinische Universitat Wien
    • Principal Investigator: Christian Primas
• Belgium
  • Antwerp, Belgium, 2650
    • Recruiting
    • UZ Antwerpen
    • Principal Investigator: Nikolaas Komen
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques universitaires Saint-Luc
    • Principal Investigator: Alex Kartheuser
  • Hasselt, Belgium, 3500
    • Recruiting
    • Jessa Ziekenhuis Hospital
    • Principal Investigator: Bart Appeltans
  • Liege, Belgium, 4000
    • Recruiting
    • Clinique CHC MontLégia
    • Principal Investigator: Arnaud Colard
  • Roeselare, Belgium, 8800
    • Recruiting
    • AZ Delta
    • Principal Investigator: Paul Pattyn
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Recruiting
      • St. Pauls Hospital
      • Principal Investigator: Ahmer Karimuddin
• Czechia
  • Brno, Czechia, 625 00
    • Recruiting
    • Fakultní Nemocnice Brno
    • Principal Investigator: Oldrich Robek
  • Brno, Czechia, 656 91
    • Recruiting
    • Fakultni Nemocnice u sv. Anny v Brne
    • Principal Investigator: Beata Hemmelova
  • Horovice, Czechia, 268 31
    • Recruiting
    • NH Hospital a.s.Nemocnice Horovice
    • Principal Investigator: Zuzana Serclova
  • Olomouc, Czechia, 779 00
    • Recruiting
    • Fakultni nemocnice Olomouc
    • Principal Investigator: Dusan Klos
• France
  • Paris, France, 75012
    • Recruiting
    • Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon
    • Principal Investigator: Isabelle Etienney
  • Paris, France, 75014
    • Recruiting
    • Hopital Saint Joseph - Paris
    • Principal Investigator: Vincent De Parades
  • Bouches-du-Rhone
    • Pierre-Benite, Bouches-du-Rhone, France, 69310
      • Recruiting
      • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
  • Gironde
    • Talence, Gironde, France, 33400
      • Recruiting
      • Fondation Maison Sante Bagatelle
      • Principal Investigator: Dominique Bouchard
  • Ille Et Vilaine
    • Rennes cedex 09, Ille Et Vilaine, France, 35000
      • Recruiting
      • CHU de Rennes - Hôpital Pontchaillou
      • Principal Investigator: Laurent Siproudhis
  • Nord
    • Lille, Nord, France, 59037
      • Recruiting
      • CHRU Hôpital Claude Huriez
      • Principal Investigator: Philippe Zerbib
  • Seine Maritime
    • Rouen Cedex, Seine Maritime, France, 76031
      • Recruiting
      • CHU de Rouen - Hôpital Charles Nicolle
      • Principal Investigator: Valerie Bridoux
• Israel
  • Be'er Ya'aqov, Israel, 7033001
    • Recruiting
    • Shamir Medical Center (Assaf Harofeh)
    • Principal Investigator: Oded Zmora
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Center
    • Principal Investigator: Hayim Gilshtein
  • Holon, Israel, 58100
    • Recruiting
    • Wolfson Medical Center
    • Principal Investigator: Eran Israeli
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center
    • Principal Investigator: Hagit Tulchinsky
• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Istituto Clinico Humanitas
      • Principal Investigator: Antonino Spinelli
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Amsterdam UMC, locatie AMC
    • Principal Investigator: Christianne Buskens
  • Utrecht, Netherlands, 3508 GA
    • Recruiting
    • UMC Utrecht
    • Principal Investigator: Herma Fidder
• United Kingdom
  • Essex
    • Chelmsford, Essex, United Kingdom, CM1 7ET
      • Recruiting
      • Broomfield Hospital
      • Principal Investigator: Tobias Hammond
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Recruiting
      • Nottingham University Hospital
      • Principal Investigator: Matthew Shale
  • Tyne & Wear
    • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP
      • Recruiting
      • Royal Victoria Infirmary.
      • Principal Investigator: Richard Brady
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Principal Investigator: Philip Fleshner
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist MD Anderson Cancer Center
      • Principal Investigator: Ron Landmann
    • Tampa, Florida, United States, 33612
      • Recruiting
      • University of South Florida - PARENT
      • Principal Investigator: Robert Bennett
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center Research Institute, Inc.
      • Principal Investigator: Florence Hosseini-Aslinia
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • GI Alliance - Baton Rouge
      • Principal Investigator: Jonathon Chapman
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital PRIME
      • Principal Investigator: Jennifer Agnew
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • UNC Hospitals
      • Principal Investigator: Hans Herfarth
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Recruiting
      • Premier Health
      • Principal Investigator: John Bruun
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University Hospital
      • Principal Investigator: Matthew Philp
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Medicine PA
      • Principal Investigator: Joshua Bleier
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Recruiting
      • Vanderbilt University Medical Center- GI Endoscopy Lab
      • Principal Investigator: Robin Dalal
  • Texas
    • Dallas, Texas, United States, 75204
      • Recruiting
      • Baylor Research Institute
      • Principal Investigator: Katerina Wells
    • Houston, Texas, United States, 77030
      • Recruiting
      • Colon & Rectal Clinic
      • Principal Investigator: Michael Snyder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Percentage of Participants With New Perianal Abscess		Baseline, 3, 6, 12 and 24 months post-index surgery

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

Helpful Links

• To obtain more information about this study, click this link.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Anticipated): May 2, 2026
• Study Completion (Anticipated): May 2, 2026

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Inflammatory Bowel Diseases; Vaginal Diseases; Intestinal Fistula; Digestive System Fistula; Rectal Fistula; Vaginal Fistula; Fistula; Crohn Disease; Rectovaginal Fistula
• Other Study ID Numbers: Alofisel-5007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No