Value of Anorectal Manometry Before Ileo- or Sigmoidostomy Closure After Rectal Resection

• Conditions: Fecal Incontinence; Quality of Life

• Registration Number: NCT02196597
• Lead Sponsor: German Society for Neurogastroenterology and Motility

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-11-04
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-18
• Last Update Submitted: 2014-07-18
• Study First Posted: 2014-07-22
• Last Update Posted: 2014-07-22
• Primary Completion: 2014-12
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• all patients planned for ileo- or sigmoidostomy closure after rectal resection for rectal carcinoma

Exclusion Criteria

• preoperative incontinence for solid stool
• dementia
• pregnancy
• latex allergy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
predictive value of preoperative anorectal manometry for postoperative fecal incontinence	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.

Secondary Outcome Measures

Name	Time	Method
fecal incontinence in patients with/without neoadjuvant radiochemotherapy	six month postoperative	Comparison of the percentage of patients with postoperative fecal incontinence after rectal resection in patients with or without neoadjuvant radiochemotherapy
predictive value of the surgeon's preoperative evaluation	six month postoperative	Clinical evaluation of the patient preoperatively with estimation (written statement) about postoperative continence/incontinence. Fecal incontinence is determined at 6 month postoperatively. Analysis of correlation between the surgeons´ predictions and the incidence of postoperative fecal incontinence

Trial Locations

Locations (3)

Hospital Vilsbiburg; 🇩🇪 Vilsbiburg, Germany

Hosptial Landshut-Achdorf; 🇩🇪 Landshut, Germany

Hospital Memmingen; 🇩🇪 Memmingen, Germany