Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease (LT-SAFCD)

Toulouse University Hospital

Status

Enrolling

Conditions

Crohn Disease

Treatments

Other: anti-TNF therapy and seton drainage

Study type

Observational

Funder types

Other

Identifiers

NCT06514092

RC31/24/0174

Details and patient eligibility

About

This research aims to evaluate the long-term recurrence risk of perianal fistulas in Crohn's disease patients who have undergone treatment with anti-TNF therapy and seton drainage.The research seeks to identify factors influencing recurrence and assess the long term effectiveness of these treatments in preventing fistula recurrence. This study will provide insights that could enhance treatment strategies and improve patient outcomes.

Full description

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.

Enrollment

81 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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