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Sponsors and Collaborators: |
University of Calgary Cook Medical Incorporated Alberta Health Services |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00955448 |
Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina. One of the treatment options available is to repair the anterior wall surgically. The goals of surgery are to return the anatomy to its usual position, ensuring that all the pelvic floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair would also be long lasting. Two surgical options are routinely performed in Calgary for repair of an anterior compartment prolapse. One option involves fixing the organs back in place using sutures. The other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The investigators do not know which of these two options is the best surgical procedure. Both may have different advantages that would result in better results. This study is designed to try and find out if one of these procedures is better, and if a larger study may be needed.
Condition | Intervention | Phase |
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Anterior Pelvic Organ Prolapse |
Device: SIS mesh (Cook Medical) Procedure: Anterior prolapse repair |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study |
Estimated Enrollment: | 50 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SIS Mesh: Experimental
Anterior prolapse repair will be reinforced using SIS mesh
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Device: SIS mesh (Cook Medical)
Anterior prolapse repair will be reinforced using surgical mesh made from porcine small intestine mucosa (Cook Medical)
Procedure: Anterior prolapse repair
Anterior prolapse repair will be conducted without using mesh reinforcement
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No-mesh: Active Comparator
Anterior prolapse repair with no mesh reinforcement
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Procedure: Anterior prolapse repair
Anterior prolapse repair will be conducted without using mesh reinforcement
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Magali Robert, MD | 403 944 8458 | magali.robert@albertahealthservices.ca |
Contact: Sue Ross, PhD | 403 944 8458 | sue.ross@albertahealthservices.ca |
Canada, Alberta | |
Foothills Medical Centre | |
Calgary, Alberta, Canada, T2N 1C5 | |
Peter Lougheed Centre | |
Calgary, Alberta, Canada, T1Y 6J4 |
Principal Investigator: | Magali Robert, MD | University of Calgary |
Responsible Party: | University of Calgary ( Dr Magali Robert ) |
Study ID Numbers: | Anterior SIS 300609, Ethics: E-22217 |
Study First Received: | August 5, 2009 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00955448 History of Changes |
Health Authority: | Canada: Health Canada |
Anterior pelvic organ prolapse Surgical repair Pelvic floor surgery Randomized clinical trial |
Pathological Conditions, Anatomical Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Prolapse Rectal Prolapse |
Pathological Conditions, Anatomical Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Prolapse Rectal Prolapse |