NCT05044182招募中不适用
Clinical Study of Decompression and Drainage Seton for the Treatment of High Horseshoe Anal Fistula
China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2021年10月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
Patients with high horseshoe anal fistula will be randomized to one of two equal group: treatment group will have decompression and drainage seton and control group will undergo cutting 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 horseshoe anal fistula
排除标准
- •Specific cause of fistula e.g. Crohn's disease.
- •Previous anorectal surgery.
- •Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
- •Patients with serious primary diseases such as tumor, malnutrition, endocrine and hematopoietic system.
结局指标
主要结局
Recurrence rate
时间窗: 12 months after the procedure
recurrence was defined as the clinical reappearance of the fistula after complete healing.
次要结局
未报告次要终点
研究者
Hui Li
Associate chief physician
China-Japan Friendship Hospital
研究点 (1)
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