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临床试验/NCT05894226
NCT05894226已完成不适用

Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele

Mansoura University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年3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
15
试验地点
2
主要终点
changes in the Wexner constipation score

研究概览

简要总结

The ideal surgical strategy for treating complex rectocele remains a topic for debate, with the transanal, transperineal, and transvaginal approach and the abdominal approach being at conflict with one another. While the transvaginal repair is more popular among gynecologists, the trans abdominal approach has become increasingly common among colorectal surgeons, in part due to the rising demand for minimally invasive surgery.

详细描述

For the treatment of rectoceles and ODS in general, the laparoscopic method has recently come to light as a promising alternative.

Laparoscopic ventral mesh rectopexy (LVMR) was originally described for the management of rectal prolapse. However, It was also recommended with encouraging results for the treatment of large symptomatic rectocele.

The present study aims to evaluate the safety and efficacy of LVMR for complex rectocele.

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
30 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • multiparous female patients.
  • aged between 30 and 60 years
  • who were diagnosed with complex anterior rectocele- more than 3cm after failed medical treatment- with history of either vaginal delivery or caesarian section.
  • complex rectocele was one having any of the following features: size > 3 cm in diameter, associated enterocoele or internal rectal prolapse

排除标准

  • paradoxical contraction of puborectalis muscle (anismus),
  • complete external rectal prolapse
  • fecal incontinence
  • other benign anal conditions
  • those who are unfit for surgery due to associated severe co-morbidities

结局指标

主要结局

changes in the Wexner constipation score

时间窗: 6 months

improvement in constipation, if the score is decreasing this means improving

次要结局

  • sexual function changes(6 months)

研究者

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

Ahmad Sakr

consultant and lecturer of general surgery

Mansoura University

研究点 (2)

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