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

NCT02196597 | Unknown

• 1 other identifier: DGNM_ARM
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Fecal Incontinence; Quality of Life

Keywords

anorectal manometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• fecal incontinence in patients with/without neoadjuvant radiochemotherapy

  six month postoperative

• predictive value of the surgeon's preoperative evaluation

  six month postoperative

Other Outcomes (1)

• 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)

  six month postoperative

Study Arms (2)

resection with RCT

rectal resection in the case of rectal carcinoma with preoperative radiochemotherapy

resection without RCT

patients with rectal resection without preoperative radiochemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients operated for rectal carcinoma in three German centers

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• German Society for Neurogastroenterology and Motility: lead

Study Sites (3)

Hosptial Landshut-Achdorf

Landshut, 84036, Germany

RECRUITING

Hospital Memmingen

Memmingen, 87700, Germany

RECRUITING

Hospital Vilsbiburg

Vilsbiburg, 81437, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 11013813 RESULT

Related Links

• Homepage of the German Society for Neurogastroenterology and Motility

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Christian Pehl, MD

  German Society for Neurogastroenterology and Motility

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Pehl, MD

CONTACT

+49 (0)8741 603152; christian.pehl@kkh-vilsbiburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: July 22, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

DE (3)