Comparative Study Between Trans-perineal Repair With or Without Limited Internal Sphincterotomy in Treatment of Type I Anterior Rectocele: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of recurrence
研究概览
简要总结
Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.
详细描述
Transperineal repair of anterior rectocele is performed in two groups of patients, the first will undergo limited posterior internal sphincterotomy, the second group will not have internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and improvement of symptoms.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with anterior rectocele
排除标准
- •Pregnant females
- •Rectocele with pelvic organ prolapse
- •Any patient with previous anorectal surgery
- •Pudendal nerve neuropathy
- •Anal fistula and sepsis
- •Patients with sphincter defect proved by endo-anal sonography
- •Patients proved to have colonic inertia either by colon transit time and/or history
- •Patients with defecography anomalies causing obstructed defecation other than rectocele (e.g. Anismus).
- •Also patients with vascular diseases, scleroderma, malnutrition, and coagulopathy were excluded.
研究组 & 干预措施
Transperineal repair with PIS
transperineal repair of anterior rectocele with limited internal sphincterotomy
干预措施: Transperineal repair with PIS (Procedure)
Transperineal repair without PIS
transperineal repair of anterior rectocele only
干预措施: Transperineal repair without PIS (Procedure)
结局指标
主要结局
Incidence of recurrence
时间窗: 18 months
Number of patients presenting with recurrent or persistent symptoms during follow up
次要结局
未报告次要终点
研究者
Sameh Emile
Lecturer of surgery
Mansoura University