Prospective Multi-center Evaluation of the Value of Anorectal Manometry Before Closure of Protective Ileostomy or Sigmoidostomy After Rectal Resection in Patients With Rectal Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- predictive value of preoperative anorectal manometry for postoperative fecal incontinence
研究概览
简要总结
Background: High prevalence of fecal incontinence after rectal resection in patients with rectal carcinoma.
Hypothesis: Anorectal manometry done before ileostomy or sigmoidostomy closure can predict fecal incontinence.
Methods: Anorectal manometry before, 1 month and 6 month after closure. Anorectal endosonography before and 1 month after closure. Prediction of postoperative incontinence by the surgeon (digital sphincter examination). Visual analog scales for continence, subjective success of operation, and global well being; Wexner and Vaizey incontinence score; Parks incontinence classification; Rockwood fecal incontinence quality of life score; each before, 1 and 6 month after closure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients planned for ileo- or sigmoidostomy closure after rectal resection for rectal carcinoma
排除标准
- •preoperative incontinence for solid stool
- •pregnancy
- •latex allergy
结局指标
主要结局
predictive value of preoperative anorectal manometry for postoperative fecal incontinence
时间窗: 6 month postoperative
Anorectal manometry is done preoperatively. Fecal incontinence is determined at 6 month postoperatively. Analysis of correlation between preoperative manometry parameter and incidence of postoperative fecal incontinence.
次要结局
- fecal incontinence in patients with/without neoadjuvant radiochemotherapy(six month postoperative)
- predictive value of the surgeon's preoperative evaluation(six month postoperative)
研究者
Dr. Christian Pehl
Chairman
German Society for Neurogastroenterology and Motility