← Back to searchRecruitingRecruiting
Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease
NCT06514092 · University Hospital, Toulouse
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Study on the Long-Term Risk of Recurrence of Anoperineal Fistula After Treatment with Anti-tumor Necrosis Factor (TNF) and Seton Drainage in Crohn's Disease : LT-SAFCD
About this study
Scientific Justification :
● Perianal fistulas are a common and challenging complication of Crohn's disease, significantly impacting patient quality of life. Infliximab, an TNFα antagonist has shown its efficacy in inducing remission of these fistulas. Seton drainage is often used alongside anti-TNF therapy to promote fistula healing and prevent abscess formation. However, data with long term follow up are still lacking on the impact of these treatments. Understanding the long-term outcomes of these combined treatments is crucial for optimizing therapeutic strategies and improving patient management.
Treatment Strategy :
● The treatment involves administering infliximab to control inflammation and promote fistula closure, along with seton drainage to maintain fistula patency and prevent abscesses, ensuring continuous drainage and reducing infection risk.
Follow-up Description :
● Patients are monitored retrospectively through medical records for a period ranging from several months to years, assessing recurrence rates and potential predictors of recurrence. Follow-up includes regular clinical evaluations, biological evaluations (blood test and fecal calprotectin), colonoscopy, imaging studies such as MRI, and patient-reported outcomes to gather comprehensive data on the long-term efficacy and safety of the combined treatment approach.
Eligibility criteria
Inclusion Criteria:
* Confirmed diagnosis of Crohn's disease
* drainage of an anal fistula with seton combined with the initiation of anti-TNF alpha treatment
* Patient who was treated in the digestive center of the Toulouse University Hospital for drainage of an anal fistula between January 1, 2000 and December 31, 2010
Exclusion Criteria:
Patient followed less than 6 months after seton drainage
Study design
Enrollment target: 81 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-09-17
Estimated completion: 2027-08-01
Last updated: 2025-01-08
Interventions
Other: anti-TNF therapy and seton drainage
Primary outcomes
- • Long-term recurrence-free survival rate of perianal fistulas (through study completion, an average of 2 years)
Sponsor
University Hospital, Toulouse · other
Contacts & investigators
ContactGuillaume LE COSQUER, MD · contact · lecosquer.g@chu-toulouse.fr · 05 61 32 20 45
ContactTevin POLYNICE · contact · polynice.t@chu-toulouse.fr
InvestigatorGuillaume LE COSQUER, MD · principal_investigator, University Hospital, Toulouse
All locations (1)
CHU de ToulouseRecruiting
Toulouse, France