Skip to main content
OpenTrials
Completed

NCT Number: NCT06514092

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Toulouse

Toulouse, France

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anti-TNF therapy and seton drainage

Other

Crohn's disease patients who have undergone treatment with anti-TNF therapy and seton drainage.

Primary outcomes

  1. Long-term recurrence-free survival rate of perianal fistulas

    Time frame: through study completion, an average of 2 years

    To evaluate the long-term recurrence-free survival rate of perianal fistulas after combined treatment with anti-TNF alpha and seton drainage

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: LT-SAFCD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.