Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair in Management of Anterior Rectocele; a Randomized Controlled Trial.
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
- 否
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
Ahmad Sakr
principal investigator
Mansoura University Hospital
