Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse
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.
Vaginal Vault Prolapse
Device: Elevate mesh
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Anatomic and Functional Outcomes of Vaginal Mesh ( ELEVATE) Compared With Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse|
- Functional and anatomical efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- operating time, cost and complications of both techniques [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097200
|Contact: Eduardo Bataller, M.D , PH. D.||firstname.lastname@example.org|
|Contact: Eduardo Bataller, M.D.; PH. D.||email@example.com|
|Hospital Clinic Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Sub-Investigator: Francisco Carmona, M.D, Ph. D.|
|Sub-Investigator: Montse Espuña, M.D., Ph. D.|
|Sub-Investigator: Montse Puig, M.D.|
|Sub-Investigator: Jordi Deu, M.D.|
|Principal Investigator:||Eduardo Bataller, M.D., Ph. D.||Hospital Clinic, Barcelona, Spain.|