Surgical Closure vs Anti-TNF in the Treatment of Perianal Fistulas in Crohn's Disease (PISA-II): a Comprehensive Cohort Design
Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jun 1, 2024
Trial Information
Current as of March 14, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • Inclusion criteria
- • ≥ 18 years
- • (re-)active perianal fistula
- • High perianal fistula tract (intersphincteric, transsphincteric, suprasphincteric) located in the upper two-thirds of the external sphincter or puborectal muscle
- • Fistula with one internal opening (based on MRI imaging). The number of external fistulas does not have to be taken into account
- • Written informed consent
- • 4.3 Exclusion criteria
- • Proctitis (defined as any active mucosal inflammation or ulcer \> 5mm in the rectum)
- • Anorectal stenosis (defined as the impossibility to introduce a proctoscope)
- • Submucosal fistulas \& low intersphincteric fistulas (lower one-third of external sphincter)
- • Rectovaginal fistula
- • Multiple internal openings
- • Use of Anti-TNF medication for more than 3 months
- • Previous failure of Anti-TNF treatment for perianal fistula
- • Patients with a stoma
- • Dementia or altered mental status that would prohibit the understanding and giving of informed consent
Trial Officials
Willem Bemelman, MD PhD
Principal Investigator
Amsterdam UMC, location AMC
About Academisch Medisch Centrum Universiteit Van Amsterdam (Amc Uva)
The Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is a leading academic medical center in the Netherlands, dedicated to advancing healthcare through innovative research, education, and patient care. Affiliated with the University of Amsterdam, AMC-UvA integrates clinical practice with cutting-edge biomedical research, fostering a multidisciplinary approach to medical challenges. The institution actively engages in clinical trials to enhance treatment options and improve patient outcomes, while promoting collaboration among healthcare professionals, researchers, and academic institutions globally. With a commitment to excellence and a focus on translational medicine, AMC-UvA plays a pivotal role in shaping the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amsterdam Zuidoost, Noord Holland, Netherlands
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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