NCT01913249撤回不适用
Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula, a Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Complication
研究概览
简要总结
The aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to LIFT surgery. The main end-points are recurrence rates and complication rates after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 65 years
- •Complex anal fistula defined as
- •anterior fistulas in women
- •branched fistulas
- •fistulas in patients with anal incontinence
- •fistulas traversing more than 30% of the anal sphincter and therefore unsuitable for simple division.
排除标准
- •Crohn's disease in the rectum
- •Previous LIFT surgery on same side
- •Patient already treated with seton > 3 weeks
- •Not able or willing to sign informed consent
研究组 & 干预措施
Intervention
Experimental
Seton through fistula 6 months prior to LIFT
干预措施: LIFT (Procedure)
Control
Active Comparator
Seton through fistula 3 weeks prior to LIFT surgery
干预措施: LIFT (Procedure)
结局指标
主要结局
Complication
时间窗: 1 year
Main complication being anal incontinence measured by St.Marks score, but all major and minor complications are registered.
Recurrence rate
时间窗: 1 year
Recurrence or non-healing of anal fistula one year after LIFT surgery
次要结局
未报告次要终点
研究者
研究点 (1)
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