Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation

Cantonal Hospital of St. Gallen1 site in 1 country52 target enrollmentJanuary 2008

ConditionsObstructed Defecation Syndrome Rectocele Intussusception SNS

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obstructed Defecation Syndrome
Sponsor: Cantonal Hospital of St. Gallen
Enrollment: 52
Locations: 1
Primary Endpoint: Quality of Life
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new technique has been developed using the new Contour® TranstarTM stapler, which was specifically designed to facilitate the STARR procedure. The investigators would like to evaluate the morbidity and quality of life.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

November 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cantonal Hospital of St. Gallen

Responsible Party

Principal Investigator

F. Hetzer

Leitender Arzt

Cantonal Hospital of St. Gallen

Eligibility Criteria

Inclusion Criteria

•Rectocele
•Intussusception

Exclusion Criteria

•Non operability
•inflammatory bowel disease

Outcomes

Primary Outcomes

Quality of Life

Time Frame: 6 months after intervention

Quality of life is measured by Fecal incontinence quality of life (FIQL) Possible range of score 0 - 4 (Depression/Self perception 4.4) 0 = worst condition * Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)