MedTrace Logo

Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

NCT01097200 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-03-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • American Medical Systems

    collaborator INDUSTRY

  • Francisco Carmona

    lead OTHER

Principal Investigators

  • Eduardo Bataller, M.D., Ph. D. · Hospital Clinic, Barcelona, Spain.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2016-11-30
Completion
2021-11-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01097200 on ClinicalTrials.gov