Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy

Sponsor
Atlantic Health System (Other)
Overall Status
Completed
CT.gov ID
NCT02248935
Collaborator
(none)
316
1
13
24.3

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    316 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Cohort Study Comparing Two Lightweight Y Meshes After Robotic-Assisted Laparoscopic Sacrocolpopexy Longterm Outcomes
    Study Start Date :
    Jul 1, 2014
    Actual Primary Completion Date :
    Aug 1, 2015
    Actual Study Completion Date :
    Aug 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Repair with Alyte or Restorelle Y-Mesh

    Women who underwent their index robotic-assisted laparoscopic sacrocolpopexy at Morristown Medical Center or Overlook Medical Center using either the Alyte Y-mesh or Restorelle Y-smartmesh between 1/2007 and 8/2011.

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Cure Rate [5-6 years]

      To be considered a "clinical cure" subjects must meet all of the following criteria: no re-operation for or non-surgical treatment of pelvic organ prolapse since the index surgery; no symptoms of vaginal bulge as measured by a validated symptom questionnaire; no Pelvic Organ Prolapse Quantification (POP-Q) points greater than 0; POP-Q point C less than or equal to -5; an answer of "satisfied" or "very satisfied" on validated Surgical Satisfaction Questionnaire

    Secondary Outcome Measures

    1. Objective Anatomic Outcome [5-6 year]

      POP-Q measurements of Pelvic Organ Prolapse will be measured comparing both mesh groups and entire combined cohort compared to 12 month findings

    2. Mesh exposure/erosion [5-6 years]

      The rate of mesh exposure or erosion will be measured

    3. Complications [5-6 years]

      any other complications related to the index surgery will be documented

    4. Symptom Comparison [5-6 years]

      to compare related symptoms such as urinary frequency, bowel function, and sexual function both between mesh groups and for the entire group compared to 12 month findings

    5. Surgical Satisfaction [5-6 years]

      The validated Surgical Satisfaction Questionnaire will be used to measure overall surgical satisfaction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 to August 2011 using either Alyte Y-mesh or Restorelle Y-mesh
    Exclusion Criteria:
    • Refusal to participate in our long-term outcome study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Urogynecology-Atlantic Health System Morristown New Jersey United States 07960

    Sponsors and Collaborators

    • Atlantic Health System

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Atlantic Health System
    ClinicalTrials.gov Identifier:
    NCT02248935
    Other Study ID Numbers:
    • 599819-2
    First Posted:
    Sep 25, 2014
    Last Update Posted:
    Jun 9, 2017
    Last Verified:
    Jun 1, 2017
    Keywords provided by Atlantic Health System
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2017