Cutting Seton Versus Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rate of healing
研究概览
简要总结
This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high trans-sphincteric cryptoglandular anal fistulas (involving >30% of the EAS muscles evaluated through magnetic resonance imaging (MRI) scan, endoanal ultrasonography)
- •suprasphincteric fistulas were enrolled
排除标准
- •Low anal fistula; -Non-glandular anal fistulas, such as tuberculous anal fistula and Crohn's anal fistula; -
- •Patients with symptoms of fecal incontinence;
- •A previous history of anal fistula surgical treatment;
- •Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
研究组 & 干预措施
decomprssion and drainage seton
干预措施: Decomprssion and drainage seton (Procedure)
Cutting seton
干预措施: Cutting seton (Procedure)
结局指标
主要结局
Rate of healing
时间窗: 6 months post-operation.
complete healing was defined as complete epithelialization of the wound, with no evidence of external fistula opening or perianal discharge under physical examination.
The healing time of the anal wound (days)
时间窗: 6 months post-operation.
the time needed to achieve complete healing of anal fistula.
Recurrence rate
时间窗: within 12 months after the procedure
recurrence was defined as the clinical reappearance of the fistula after complete healing, removal or fall-off of seton
次要结局
未报告次要终点
研究者
Hui Li
Associate chief physician
China-Japan Friendship Hospital