Outcome of Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete cure of symptoms
研究概览
简要总结
We assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR with vertical plication of the rectovaginal septum as compared to the horizontal plication with regards to improvement in ODS, recurrence of rectocele, postoperative complications and dyspareunia.
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
- •Vertical plication of the rectovaginal septum was done
排除标准
- •patients with ODS caused by conditions other than rectocele such as anismus and internal rectal prolapse
- •patients with slow transit constipation.
- •patients with recurrent rectocele after previous surgery.
- •patients with pre-existing FI
- •patients with associated anorectal pathology.
研究组 & 干预措施
Vertical plication
Vertical plication of the rectovaginal septum was done
干预措施: Vertical plication (Procedure)
Horizontal plication
Horizontal plication of the rectovaginal septum was done
干预措施: Horizontal plication (Procedure)
结局指标
主要结局
Complete cure of symptoms
时间窗: 12 months after repair
Absence of symptoms of constipation with Wexner score \<2
次要结局
未报告次要终点