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临床试验/NCT06514092
NCT06514092已完成不适用

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

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2024年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
2
主要终点
Long-term recurrence-free survival rate of perianal fistulas

研究概览

简要总结

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.

详细描述

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 :

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patient followed less than 6 months after seton drainage

结局指标

主要结局

Long-term recurrence-free survival rate of perianal fistulas

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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