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A Study of Surgical Interventions in Fistulizing Conditions
Sponsor: Takeda
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.
Official title: SPOTLITE: Prospective Observational Study on the Clinical Outcomes of Surgical Interventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
750
Start Date
2021-08-05
Completion Date
2026-05-02
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Locations (41)
Cedars-Sinai Medical Center
Los Angeles, California, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
University of South Florida - PARENT
Tampa, Florida, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
GI Alliance - Baton Rouge
Baton Rouge, Louisiana, United States
Lenox Hill Hospital PRIME
New York, New York, United States
UNC Hospitals
Chapel Hill, North Carolina, United States
Premier Health
Dayton, Ohio, United States
Penn Medicine PA
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center- GI Endoscopy Lab
Nashville, Tennessee, United States
Baylor Research Institute
Dallas, Texas, United States
Colon & Rectal Clinic
Houston, Texas, United States
AKH - Medizinische Universitat Wien
Vienna, Austria
UZ Antwerpen
Antwerp, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Jessa Ziekenhuis Hospital
Hasselt, Belgium
Clinique CHC MontLegia
Liège, Belgium
AZ Delta
Roeselare, Belgium
St. Pauls Hospital
Vancouver, British Columbia, Canada
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
NH Hospital a.s.Nemocnice Horovice
Hořovice, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
Pierre-Bénite, Bouches-du-Rhone, France
Fondation Maison Sante Bagatelle
Talence, Gironde, France
CHU de Rennes - Hopital Pontchaillou
Rennes, Ille Et Vilaine, France
CHRU Hopital Claude Huriez
Lille, Nord, France
CHU de Rouen - Hopital Charles Nicolle
Rouen, Seine Maritime, France
Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon
Paris, France
Hopital Saint Joseph - Paris
Paris, France
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, Israel
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Amsterdam UMC, Locatie AMC
Amsterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
Broomfield Hospital
Chelmsford, Essex, United Kingdom
Nottingham University Hospital
Nottingham, Nottinghamshire, United Kingdom
Royal Victoria Infirmary.
Newcastle upon Tyne, Tyne & Wear, United Kingdom