Surgical Treatment of Obstructed Defecation Syndrome

Not Applicable

• Conditions: Sensation of Inadequate Defecation; Rectal Prolapse; Rectocele

• Registration Number: NCT01899209
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures has been introduced to treat patients affected by this disease. The most used are STARR and ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-15
• Study Start: 2013-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-26
• Last Update Posted: 2014-06-27
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients affected by Obstructed Defecation with ODS score >11
• Symptomatic rectal Intussusception and/or defecographic finding of rectocele>2 cm
• Failure of at least 6 months of medical therapy
• Exclusion of neoplasm by rectosigmoidoscopy/colonoscopy

Exclusion Criteria

• Patients affected by complete rectal prolapse
• Patients affected by slow transit constipation
• Patients affected by anismus
• Patients affected by pelvic organ prolapse
• Patients with previous rectal or anal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional result	12 months	comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Anatomical result	12 months	Comparison of clinical and radiological data before and 12 months after surgery

Trial Locations

Locations (1)

University Hospital; 🇮🇹 Bologna, Italy