Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 12:35 AM
Study NCT ID:
NCT06514092
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LT-SAFCD
Brief Summary:
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.
Detailed 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.
● 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: