NCT01097200

Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

Anatomic and Functional Outcomes of Vaginal Mesh ( ELEVATE) Compared With Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Francisco Carmona · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vaginal Vault Prolapse
• Enterocele
• Uterine Prolapse
• Cystocele
• Rectocele

Interventions

Type	Name	Description
DEVICE	Elevate mesh	The correction of the prolapse can be made by this new technique.
DEVICE	Sacrocolpopexy	Attach a mesh between the vagina and the promontorium.

Timeline

• Start date: 2010-05-01
• Primary completion: 2016-11-01
• Completion: 2021-11-01
• First posted: 2010-04-01
• Last updated: 2021-03-23

Locations

1 site across 1 country: Spain