Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

Sponsor

Francisco Carmona (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01097200

Collaborator

American Medical Systems (Industry)

Enrollment

Location

Arms

138.1

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Vault Prolapse Enterocele Uterine Prolapse Cystocele Rectocele	Device: Elevate mesh Device: Sacrocolpopexy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Nov 1, 2016

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Elevate meshes 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 Names: Pelvic meshes
Other: Sacrocolpopexy Sacrocolpopexy for the correction of the prolapse	Device: Sacrocolpopexy Attach a mesh between the vagina and the promontorium. Other Names: Colpofixation

Arm

Intervention/Treatment

Other: Elevate meshes

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 Names:

Pelvic meshes

Other: Sacrocolpopexy

Sacrocolpopexy for the correction of the prolapse

Device: Sacrocolpopexy

Attach a mesh between the vagina and the promontorium.

Other Names:

Colpofixation

Outcome Measures

Primary Outcome Measures

Functional and anatomical efficacy [1 year]

Secondary Outcome Measures

operating time, cost and complications of both techniques [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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