NCT03801291已完成不适用
Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Improvement in constipation
研究概览
简要总结
Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients with anterior rectocele
排除标准
- •Male patients.
- •Combined rectocele with internal rectal prolapse.
- •Associated anorectal condition such as hemorrhoids and anal fissure.
- •Pregnancy.
- •Unwilling to participate in the trial
结局指标
主要结局
Improvement in constipation
时间窗: 6 and 12 months after surgery
decrease in Wexner constipation score by 25%
次要结局
未报告次要终点
研究者
Sameh Emile
Lecturer of general surgery
Mansoura University
研究点 (2)
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