NCT03983174已完成不适用
Drainage Seton Around the External Anal Sphincter With Mucosal Advancement Flap Versus External Anal Sphincter Preserving Seton in Treatment of Trans-sphincteric Anal Fistula
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- fecal incontinence
研究概览
简要总结
Patients with high trans-sphincteric anal fistula will be randomized to one of two equal group: group 1 will have drainage seton with mucosal advancement flap and group 2 will undergo external anal sphincter sparing seton
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from high trans-sphincteric anal fistula
排除标准
- •Acute sepsis.
- •Specific cause of fistula e.g. Crohn's disease
- •Strictured anorectum.
- •Any degree of incontinence
- •Recurrent anal fistula.
- •Low anal fistula.
- •Previous anorectal surgery.
研究组 & 干预措施
Drainage seton with flap
Experimental
Drainage seton will be put around the external anal sphincter with mucosal advancement flap
干预措施: Drainage seton with flap (Procedure)
EAS sparing seton
Experimental
Rerouting of the seton around the internal anal sphincter sparing the external sphincter will be done
干预措施: EAS sparing seton (Procedure)
结局指标
主要结局
fecal incontinence
时间窗: 12 months after surgery
Number of patients who develop fecal incontinence as assessed by Wexner Incontinence score
次要结局
未报告次要终点
研究者
Sameh Emile
Principal investigator
Mansoura University
研究点 (2)
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