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临床试验/NCT06633172
NCT06633172已完成不适用

Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair in Management of Anterior Rectocele; a Randomized Controlled Trial.

Mansoura University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4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
40
试验地点
2
主要终点
Improvement of constipation

研究概览

简要总结

This study aims to compare the effect of laparoscopic ventral mesh rectopexy versus trans vaginal repair in management of anterior rectocele in females regarding functional outcomes.

详细描述

Rectocele is the protrusion of the anterior wall of the rectum into the vaginal lumen through the rectovaginal fascia and posterior vaginal wall. Symptomatic rectocele affects postmenopausal women and causes obstructed defecation Significant rectal emptying difficulties, straining at defecation, manually assisted defecation, the need for perineal or vaginal digitation, and local symptoms such as vaginal bulging and pelvic heaviness in 30-70% of cases have been described as symptoms of rectocele .

Constipation can be managed with dietary measures, laxatives, and biofeedback training , which can be beneficial for patients with modest symptoms. Surgical treatment is recommended if conservative treatment fails to alleviate symptoms . However, some patients may be left with constipation, fecal incontinence, incomplete bowel evacuation, or sexual dysfunction despite the correction of the anatomical defect. The selection of patients for surgical intervention for symptomatic rectocele remains a matter of debate.

There is still a controversy between abdominal approaches and the transanal, transperineal, and transvaginal approaches as the optimal surgical approach to treat complex rectocele. While the latter is preferred by gynecologists, the former has increased in popularity among colorectal surgeons, aided in part by the growing interest in minimally invasive surgery.

This study aimed to evaluate the outcome of LVMR in comparison with TVR of anterior rectocele regarding the improvement in constipation score and sexual-related quality of life, surgical outcomes and postoperative complications.

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
Double (Care Provider, Outcomes Assessor)

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

  • Female patients aged between 30 and 60 years, presented with symptomatic rectocele with failed conservative treatments.
  • anterior rectocele larger than 3 cm in size with retention of the contrast in the rectocele on defecography.
  • excessive straining, sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia.

排除标准

  • significant urinary manifestations due to anterior vaginal wall prolapse.
  • patients with recurrent rectocele
  • complete external rectal prolapse
  • isolated anismus
  • connective tissue disease
  • patients with slow-transit constipation
  • fecal incontinence (FI), or abnormal thyroid function.

结局指标

主要结局

Improvement of constipation

时间窗: 6 month to 1 year

The primary outcome of the study was the absolute decline in constipation score(Cleveland clinic constipation score). This score is composed of 8 questions. Score ranges from 0 to 32. The lowest score is 0 which means no constipation, while the highest is 32 which means worsening of the constipation. So, the decline in the score means improving of the constipation.

次要结局

  • improvement of sexual function(6 month to 1 year)

研究者

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

Ahmad Sakr

principal investigator

Mansoura University Hospital

研究点 (2)

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