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临床试验/NCT04502953
NCT04502953已完成不适用

Outcome of Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele; a Randomized Controlled Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年6月1日最近更新:
适应症

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

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.

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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