跳至主要内容
临床试验/NCT00928239
NCT00928239Unknown不适用

Laparoscopic Sacropexy: Randomized Clinical Trial to Compare Two Different Attachment Sites of the Dorsal Mesh at the Vaginal Insertion(MeshPlace)

Kantonsspital Aarau2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
88
试验地点
2
主要终点
Rate of Postoperative Constipation

研究概览

简要总结

The purpose of this study is to compare postoperative complications and outcome two different attachment sites of the dorsal mesh support in laparoscopic sacropexy.

详细描述

Laparoscopic sacropexy has become a well established treatment option for vaginal vault prolapse with excellent outcome and low rates of recurrence. Compared to the similar vaginal sacropexy procedure a significant rate of postoperative constipation is reported. As the surgical technique is very similar for both procedures it could be possible that the exposure of the lower vaginal wall and placement and of the dorsal mesh and closer proximity to the colon in laparoscopic sacropexy might cause this. In this randomized controlled clinical trial we compare two different attachment sites for the dorsal mesh during laparoscopic sacropexy. One group is randomized for attachment in the middle of the dorsal wall of the vaginal stump and for the other group preparation and attachment for the dorsal mesh is performed deeper in the lower pelvis for an attachment at the distal part of the dorsal vaginal wall.

Peri-operative data, intra- and postoperative complications and results of short-term (constipation) and long-term( recurrences rate) outcome are recorded.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • vaginal vault prolapse
  • recurrence of vaginal vault prolapse
  • signed consent

排除标准

  • rectocele

结局指标

主要结局

Rate of Postoperative Constipation

时间窗: 6 to 8 weeks postoperatively

次要结局

未报告次要终点

研究者

发起方
Kantonsspital Aarau
申办方类型
Other

研究点 (2)

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