External Anal Sphincter-Sparing Seton After Rerouting Versus Ligation of Intersphincteric Fistula Tract (LIFT) In Treatment Of Complex Anal Fistula: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Clinical Healing of anal fistula
研究概览
简要总结
This study aims to compare the efficacy of two surgical techniques in treatment of complex anal fistulas. The first technique involves rerouting of the fistula tract with placement of a vessel loop seton around the internal anal sphincter, sparing the external sphincter whereas the second technique entails ligation of inter-sphincteric fistulous tract (LIFT). The main objectives of the study are to assess the success rate, time to healing, change in quality of life, and complications of each procedure including fecal incontinence.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of either sex with complex anal fistula including high trans-sphincteric, supra-sphincteric, extra-sphincteric, and anterior fistula in female
排除标准
- •Patients with simple anal fistulas, including intersphicnteric and low trans-sphincteric fistulas.
- •ASA IV and V (The American Society of Anesthesiologists Physical Status classification system) unfit patients
- •Patient with any grade of anal incontinence.
- •Patients with concomitant anal pathology.
结局指标
主要结局
Clinical Healing of anal fistula
时间窗: 12 months after surgery
Clinical healing is assessed by clinical examination during follow-up and is defined as Complete epithelization of the anal wound with no residual fistula tract or external opening or discharge
次要结局
未报告次要终点
研究者
Sameh Emile
Associate professor of surgery
Mansoura University