Status:
UNKNOWN
Comparison of Quality of Life With or Without Automatic Seton Placement in Perianal Crohn's Fistula
Lead Sponsor:
Fondation Hôpital Saint-Joseph
Conditions:
Crohn Disease
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
In patients with Crohn's disease, anal fistulas are usually treated in three stages: 1) close examination of the fistula and drainage with a seton, 2) pharmacological treatment of the inflammatory com...
Eligibility Criteria
Inclusion
- Patients with an anal fistula requiring surgical management in the context of Crohn's disease, with or without anti-TNF treatment (infliximab or adalimumab)
- Patient over 16 years of age (for minors, the consent of one of the parents will be requested)
- Patient with health insurance coverage
- French-speaking patient
- Signed written informed consent
Exclusion
- Patient already included in a type 1 interventional research protocol (RIPH1)
- Patient under guardianship or curatorship
- Patient incarcerated
- Patient under legal protection
- Patient refusing randomization or follow-up
- Patient refusing the medical protocol for anti-TNF treatment (infliximab or adalimumab)
- Patient already experiencing treatment failure on optimized infliximab treatment; by contrast, those experiencing treatment failure on adalimumab alone may be included
- Patient allergic or intolerant to the two anti-TNF agents (infliximab and adalimumab)
- Patient with a stoma
- Patient with an ano-recto-vaginal fistula
- Patient with anal or rectal stenosis
- Patient with ileo-anal anastomosis
- Patient without preoperative MRI
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 24 2025
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05330416
Start Date
May 25 2022
End Date
May 24 2025
Last Update
July 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014