NCT00252369终止不适用
Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 试验地点
- 5
- 主要终点
- Fistula healing
研究概览
简要总结
This study is aimed to assess the hypothesis that instillation of fibrin glue with the induction of local conditions using Infliximab, may be useful in the treatment of perianal Crohn's disease.
详细描述
Patients with perianal fistulae of Crohn's disease will be prospectively enrolled and receive 3 doses of Infliximab. If reduction of fistula associated discharge of at least 50% will be recorded, commercially available fibrin glue will be instilled into the fistula tract using standard surgical techniques. The patients will be followed for 6 months for fistula healing and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Perianal fistula of Crohn's dis
排除标准
- •More then 2 fistulae perianal sepsis known contraindication to infliximab or glue
结局指标
主要结局
Fistula healing
次要结局
- Quality of life
- Complications
研究者
研究点 (5)
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