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Surgical Outcomes of Vaginal Prolapse Repair With Elevate

Sponsor
Larry Sirls (Other)
Overall Status
Completed
CT.gov ID
NCT01190618
Collaborator
(none)
417
Enrollment
1
Location
77
Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators hypothesize that the less invasive Elevate mesh results in a shorter operative time, lower blood loss, complications, postoperative pain and earlier discharge from the hospital.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    417 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Surgical Outcomes of Vaginal Prolapse Repair With the Elevate Prolapse Repair Kit
    Study Start Date :
    Aug 1, 2010
    Actual Primary Completion Date :
    Dec 31, 2016
    Actual Study Completion Date :
    Dec 31, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of Outcomes [3 Months]

      To evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Profift.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Women who have had a vaginal repair with Elevate prolapse repair kit
    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 William Beaumont Hospital Royal Oak Michigan United States 48073

    Sponsors and Collaborators

    • Larry Sirls

    Investigators

    • Principal Investigator: Larry Sirls, MD, William Beaumont Hospitals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Larry Sirls, Principal Investigator, William Beaumont Hospitals
    ClinicalTrials.gov Identifier:
    NCT01190618
    Other Study ID Numbers:
    • 2010-176
    First Posted:
    Aug 27, 2010
    Last Update Posted:
    Feb 16, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Uterine Prolapse
    Prolapse

    Study Results

    No Results Posted as of Feb 16, 2017