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临床试验/NCT00771225
NCT00771225Unknown4 期

A National Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift)

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2008年11月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
180
试验地点
1
主要终点
Correction of genital prolapse

研究概览

简要总结

180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.

详细描述

180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.Are eligible women aged between 50 and 80 years old.

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
Single (Care Provider)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Between 50 and 80 yrs

排除标准

  • •Less than 50 and more than 80 yrs

研究组 & 干预措施

prolapse surgery with fascial repair

Other

干预措施: fascial repair (Procedure)

prolapse surgery with fascial repair

Other

干预措施: mesh repair (Procedure)

prolapse surgery with mesh repair

Other

干预措施: fascial repair (Procedure)

prolapse surgery with mesh repair

Other

干预措施: mesh repair (Procedure)

结局指标

主要结局

Correction of genital prolapse

时间窗: 8 years

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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