Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse
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|ClinicalTrials.gov Identifier: NCT01097200|
Recruitment Status : Active, not recruiting
First Posted : April 1, 2010
Last Update Posted : June 8, 2018
Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. New meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published.
The investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Vault Prolapse Enterocele Uterine Prolapse Cystocele Rectocele||Device: Elevate mesh Device: Sacrocolpopexy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anatomic and Functional Outcomes of Vaginal Mesh ( ELEVATE) Compared With Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||May 2020|
The use of Elevate (American Systems trade mark) meshes for the treatment of pelvic prolapse.
Device: Elevate mesh
The correction of the prolapse can be made by this new technique.
Other Name: Pelvic meshes
Sacrocolpopexy for the correction of the prolapse
Attach a mesh between the vagina and the promontorium.
Other Name: Colpofixation
- Functional and anatomical efficacy [ Time Frame: 1 year ]
- operating time, cost and complications of both techniques [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097200
|Hospital Clinic Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Eduardo Bataller, M.D., Ph. D.||Hospital Clinic, Barcelona, Spain.|