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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fecal Incontinence, Quality of Life

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| resection with RCT<br>rectal resection in the case of rectal carcinoma with preoperative radiochemotherapy | |
| resection without RCT<br>patients with rectal resection without preoperative radiochemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictive value of preoperative anorectal manometry for postoperative fecal incontinence | 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. | 6 month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal incontinence in patients with/without neoadjuvant radiochemotherapy | Comparison of the percentage of patients with postoperative fecal incontinence after rectal resection in patients with or without neoadjuvant radiochemotherapy | six month postoperative | 
| predictive value of the surgeon's preoperative evaluation | 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 | six month postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorectal manometry