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

G

German Society for Neurogastroenterology and Motility

Status

Unknown

Conditions

Quality of Life
Fecal Incontinence

Study type

Observational

Funder types

Other

Identifiers

NCT02196597
DGNM_ARM

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

resection with RCT
Description:
rectal resection in the case of rectal carcinoma with preoperative radiochemotherapy
resection without RCT
Description:
patients with rectal resection without preoperative radiochemotherapy

Trial contacts and locations

3

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Central trial contact

Christian Pehl, MD

Data sourced from clinicaltrials.gov

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