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临床试验/NCT02609555
NCT02609555已完成不适用

Trans-anal Endoscopic Microsurgery (TEM) Assisted Perineal Rectopexy With Postanal Repair and Anal Cerclage In Treatment of Rectal Prolapse (Novel Technique)

Mansoura University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Recurrence of prolapse

研究概览

简要总结

Curvilinear incision in the postanal space, through the intersphincteric plane, insertion of Proctoscope of TEM technique and dissection till sacral promontory, insertion of mesh between the rectum and sacrum, post anal repair then anal cerclage width absorbable suture.

详细描述

Perineal Rectopexy is performed by an incision in the intersphincteric space followed by dissection till the sacral promontory then Proctoscope is inserted to complete the dissection .Mesh is inserted and fixed to the sacrum with laparoscopic tacker ( or can be left unfixed) then postanal repair is conducted in two layers ( levatorplasty then sphincteroplasty) and finally Ana cerclage is done with polyglactin 0 sutures

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with complete or partial rectal prolapse

排除标准

  • patients unfit for surgery
  • patients with previous surgery for rectal prolapse
  • patients with associated anorectal pathology (e.g fistula )
  • patients with constipation as a predominant symptom.

结局指标

主要结局

Recurrence of prolapse

时间窗: 12 months

Number of patients presenting with recurrent rectal prolapse within 12 months after surgery

次要结局

  • Improvement of continence state(12 months)

研究者

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

Sameh Emile

Lecturer of general surgery

Mansoura University

研究点 (1)

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