Comparative Study Between Surgical and Non Surgical Treatment of Anismus in Patients With Symptoms of Obstructed Defecation
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
- improvement in bowel habit (regarding the straining severity, anorectal pain,number of weakly bowel movement,sensation of incomplete defecation and need of digitation or enema and using constipation score)
研究概览
简要总结
Comparative study between surgical and non surgical treatment of anismus in patients with symptoms of obstructed defecation.
Anismus is a significant cause of chronic constipation. This study came to compare the results of BFB training , BTX-A injection and PDPR in the treatment of anismus patients. Patients and methods: Seventy two anismus patients fulfilled Rome II criteria for functional constipation were included in this study. All patients underwent anorectal manometry, balloon expulsion test, defecography, and electromyography activity of the EAS. All patients had non relaxing puborectalis muscle.. The patients were randomized into three groups. Group I patients received biofeedback therapy, two times per week for about 1 month. Group II patients were injected with BTX- A. Group 111 partial division of puborectalis was done. Follow up was conducted weekly in the first month then monthly for about 1 year.
详细描述
Key words:
Obstructed defecation, chronic constipation, puborectalis, pelvic floor
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 (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60patients fulfilled Rome II criteria for functional constipation
- •All patients were unresponsive to laxatives or enema use
排除标准
- •Pregnant patients
- •Patients with sphincteric defect
- •Any patient proved to have colonic inertia by colon transit time
- •Any patient with previous history of pelvic surgery e.g. mesh rectopexy
- •Duhamel operation were excluded
研究组 & 干预措施
2 BTX A
Injected with BTX-A in the left lateral position; anesthesia was not required
干预措施: BTX A (Other)
3: PDPR
Inner half of puborectalis sling was divided on each side by using a scalpel NO
干预措施: PDPR (Procedure)
1:BFD
The investigators used pressure based biofeedback training, using a perfused eight-channel polyvinyl catheter with a compliant balloon at the tip
干预措施: BFD (Other)
结局指标
主要结局
improvement in bowel habit (regarding the straining severity, anorectal pain,number of weakly bowel movement,sensation of incomplete defecation and need of digitation or enema and using constipation score)
时间窗: 1 year
次要结局
- per rectal examination,manometeric relaxation,balloon expulsion,defecogram,EMG examination of anal sphincter to monitor any change in paradoxical contraction,recurrences,incontinence,complication(1 year)