Long Term Results of STARR With Contour Transtar

Completed

• Conditions: Rectocele; Intussusception of Rectum; Rectal Prolapse

• Registration Number: NCT02971332
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study the investigators want to evaluate the long term results of Stapled Transanal Rectal Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was conducted.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2010-01
• Study Completion: 2016-01
• Status Verified: 2016-11
• Study First Submitted: 2016-11-20
• Study First Submitted QC: 2016-11-21
• Last Update Submitted: 2016-11-21
• Study First Posted: 2016-11-22
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

• ODS
• presence of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception.

Exclusion Criteria

• anal sphincter contractile deficiency
• previous rectal resection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
degree of constipation	5 years	Cleveland Clinic Constipation Score

Secondary Outcome Measures

Name	Time	Method
Surgical Complications	0-6 months	intraoperative and postoperative surgical complications