Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514092
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohns Disease
Sponsor:
None
Organization:
None
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 Crohns Disease LT-SAFCD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 Crohns disease patients who have undergone treatment with anti-TNF therapy and seton drainageThe 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 Crohns 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 Crohns 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None