Evaluating long-term recurrence of anal fistulas in Crohn's disease patients
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
This study looks at how often anal fistulas come back in people with Crohn's disease after they have been treated with specific therapies, to see what factors might affect this.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 81 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Drugs / interventions | Infliximab |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06514092 on ClinicalTrials.gov |
What this trial studies
This research evaluates the long-term risk of recurrence of perianal fistulas in patients with Crohn's disease who have received anti-TNF therapy and seton drainage. The study aims to identify factors influencing recurrence and assess the effectiveness of these treatments over time. Patients will be monitored retrospectively through medical records, with follow-up including clinical evaluations, biological tests, imaging studies, and patient-reported outcomes to gather comprehensive data on treatment efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates are patients with a confirmed diagnosis of Crohn's disease who have undergone seton drainage and anti-TNF therapy.
Not a fit: Patients who have not been followed for at least six months after seton drainage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for managing perianal fistulas in Crohn's disease, enhancing patient outcomes.
How similar studies have performed: Other studies have shown success with similar approaches in managing perianal fistulas, but long-term data remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toulouse
- CHU de Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Guillaume LE COSQUER, MD — University Hospital, Toulouse
- Study coordinator: Guillaume LE COSQUER, MD
- Email: lecosquer.g@chu-toulouse.fr
- Phone: 05 61 32 20 45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.