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

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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Fecal Incontinence

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Germany
  • Landshut, Germany, 84036
    • Recruiting
    • Hosptial Landshut-Achdorf
    • Contact: Johannes Schmidt, MD; Phone Number: 0049 871 4042770; Email: johannes.schmidt@lakumed.de
    • Principal Investigator: Johannes Schmidt, MD
  • Memmingen, Germany, 87700
    • Recruiting
    • Hospital Memmingen
    • Contact: Albert Pfeiffer, MD; Phone Number: 0049 8331 702640; Email: Silke.Eipper@klinikum-memmingen.de
    • Principal Investigator: Albert Pfeiffer, MD
  • Vilsbiburg, Germany, 81437
    • Recruiting
    • Hospital Vilsbiburg
    • Principal Investigator: Christian Pehl, MD
    • Sub-Investigator: Nikolaus Steigemann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients operated for rectal carcinoma in three German centers

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
resection with RCT; rectal resection in the case of rectal carcinoma with preoperative radiochemotherapy
resection without RCT; patients with rectal resection without preoperative radiochemotherapy

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
prediction of postoperative fecal incontinence by the score of Stadelmaier and Matzel (Score =18.230 - 0.94x anastomotic level - 0.18 x resting pressure + 3.72 x radiochemotherapy (done 1, not done 0)	Analysis of correlation between the preoperatively predicted Wexner score and the observed Wexner score six month postoperative.	six month postoperative

Collaborators and Investigators

• Sponsor: German Society for Neurogastroenterology and Motility
• Investigators: Principal Investigator: Christian Pehl, MD, German Society for Neurogastroenterology and Motility

Publications and helpful links

General Publications

• Stadelmaier U, Bittorf B, Meyer M, Hohenberger W, Matzel KE. [Can continence function after rectal resection be prognostically estimated?]. Chirurg. 2000 Aug;71(8):932-8. doi: 10.1007/s001040051158. German.

Helpful Links

• Homepage of the German Society for Neurogastroenterology and Motility

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: July 18, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Estimate): July 22, 2014
• Last Update Submitted That Met QC Criteria: July 18, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: anorectal manometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: DGNM_ARM