Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

Not Applicable

• Conditions: Vaginal Vault Prolapse; Enterocele; Cystocele; Uterine Prolapse; Rectocele
• Interventions: Device: Elevate mesh; Device: Sacrocolpopexy

• Registration Number: NCT01097200
• Lead Sponsor: Francisco Carmona

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Study Start: 2010-05
• Primary Completion: 2016-11
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-20
• Last Update Posted: 2021-03-23
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Subject has been diagnosed with one or more clinically significant anterior, apical, or posterior genital prolapse disorder(s)(symptomatic POP-Q stage II or higher) requiring surgical repair.

Exclusion Criteria

• Investigator determines subject is not a candidate for surgical repair of her genital prolapse.
• Subject has had a prior prolapse procedure involving graft placement (synthetic or biologic)
• Subject has active or latent systemic infection or signs of tissue necrosis.
• Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement / prosthesis.
• Subject is currently pregnant or intends to become pregnant during the study period.
• Subject has had radiation therapy to the pelvic area.
• Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
• Subject has uncontrolled diabetes.
• Subject is on any medication with could result in compromised immune response, such as immune modulators.
• Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study.
• Subject is unwilling or unable to give valid informed consent.
• Subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of Life questionnaires and return for all follow-up visits.
• Subject with contraindications for laparoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elevate meshes	Elevate mesh	The use of Elevate (American Systems trade mark) meshes for the treatment of pelvic prolapse.
Sacrocolpopexy	Sacrocolpopexy	Sacrocolpopexy for the correction of the prolapse

Primary Outcome Measures

Name	Time	Method
Functional and anatomical efficacy	1 year

Secondary Outcome Measures

Name	Time	Method
operating time, cost and complications of both techniques	6 months

Trial Locations

Locations (1)

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain