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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02196597
Enrollment
30
Registered
2014-07-22
Start date
2013-01-31
Completion date
2015-01-31
Last updated
2014-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinence, Quality of Life

Keywords

anorectal manometry

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.

Interventions

None listed

Sponsors

German Society for Neurogastroenterology and Motility
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
predictive value of preoperative anorectal manometry for postoperative fecal incontinence6 month postoperativeAnorectal 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

MeasureTime frameDescription
fecal incontinence in patients with/without neoadjuvant radiochemotherapysix month postoperativeComparison 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 evaluationsix month postoperativeClinical 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

Other

MeasureTime frameDescription
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 postoperativeAnalysis of correlation between the preoperatively predicted Wexner score and the observed Wexner score six month postoperative.

Countries

Germany

Contacts

Primary ContactChristian Pehl, MD
christian.pehl@kkh-vilsbiburg.de+49 (0)8741 603152

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026