Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease
NCT ID: NCT06514092
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
81 participants
OBSERVATIONAL
2024-09-17
2027-08-01
Brief Summary
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Detailed Description
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● 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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Crohn's patients
anti-TNF therapy and seton drainage
Crohn's disease patients who have undergone treatment with anti-TNF therapy and seton drainage.
Interventions
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anti-TNF therapy and seton drainage
Crohn's disease patients who have undergone treatment with anti-TNF therapy and seton drainage.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Guillaume LE COSQUER, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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CHU de Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Guillaume LE COSQUER
Role: backup
Other Identifiers
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RC31/24/0174
Identifier Type: -
Identifier Source: org_study_id
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