Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

Not Applicable

Completed

• Conditions: Obstructed Defecation Syndrome; Rectocele; Intussusception; SNS
• Interventions: Procedure: Stapled transanal rectum resection

• Registration Number: NCT00673400
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Primary Completion: 2008-11
• Study Completion: 2009-11
• Results First Submitted: 2012-07-16
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-01
• Last Update Submitted: 2012-10-01
• Results First Posted: 2012-10-02
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Rectocele
• Intussusception

Exclusion Criteria

• Non operability
• inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stapled transanal rectum resection	Stapled transanal rectum resection	patients operated with stapled transanal rectum resection

Primary Outcome Measures

Name	Time	Method
Quality of Life	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)

Secondary Outcome Measures

Name	Time	Method
Morbidity	1 year	Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)
Hospitalization	1 day to 1 year (until release from hospital)	Length of hospital stay (Date of release - Date of admission + 1)

Trial Locations

Locations (1)

Department of Surgery, Cantonal Hospital St. Gallen; 🇨🇭 St. Gallen, Switzerland