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临床试验/NCT04117633
NCT04117633已完成不适用

Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children : A Comparative Randomized Study

Al-Azhar University0 个研究点目标入组 64 人开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
主要终点
Signs of improvement

研究概览

简要总结

Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group Results:

详细描述

Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy Patient and Methods: The prospective study was conducted at Pediatric Surgery Department, Al-Azhar university hospitals, Cairo, Egypt . The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with persistant complete Rectal Prolapse.
  • Failure of conservative treatment.
  • more than 2 attacks of prolapse requiring manual reduction.

排除标准

  • Sever constipation
  • Previous abdominal or pelvic surgery with extensive adhesions.
  • Cases older than 12ys,
  • Patients with rectal polyp

研究组 & 干预措施

Mesh Rectopexy

Active Comparator

Using Laparoscopy

干预措施: Laparoscopy (Device)

Suture Rectopexy

Active Comparator

Using Laparoscopy

干预措施: Laparoscopy (Device)

结局指标

主要结局

Signs of improvement

时间窗: 12 weeks

No recurrence of Rectal Prolapse

次要结局

  • Signs of improvement(30 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

abdelaziz yehya

professor

Al-Azhar University

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