PRO-REST: Surgical Treatment of Obstructed Defecation Syndrome
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group A STARR |
Procedure: STARR
|
Experimental: Group B Laparoscopic ventral Rectopexy |
Procedure: Laparoscopic Ventral Rectopexy
|
Outcome Measures
Primary Outcome Measures
- Functional result [12 months]
comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery
Secondary Outcome Measures
- Anatomical result [12 months]
Comparison of clinical and radiological data before and 12 months after surgery
Other Outcome Measures
- Quality of life and safety [12 months]
Comparison of Constipation-Related Quality of Life questionnaire (CRQoL) before and 12 months after surgery Comparison of morbidity and mortality rate between the two procedures
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients affected by Obstructed Defecation with ODS score >11
-
Symptomatic rectal Intussusception and/or defecographic finding of rectocele>2 cm
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Failure of at least 6 months of medical therapy
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Exclusion of neoplasm by rectosigmoidoscopy/colonoscopy
Exclusion Criteria:
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Patients affected by complete rectal prolapse
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Patients affected by slow transit constipation
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Patients affected by anismus
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Patients affected by pelvic organ prolapse
-
Patients with previous rectal or anal surgery
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Hospital | Bologna | Italy | 40138 |
Sponsors and Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- University of Bologna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-REST