Prospective Cohort Study of Robotic Assisted Laparoscopic Sacrocolpopexy Using MPATHY Restorelle Mesh

Sponsor
Atlantic Health System (Other)
Overall Status
Completed
CT.gov ID
NCT01320618
Collaborator
(none)
120
24

Study Details

Study Description

Brief Summary

Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcome. This advanced procedure is offered at Morristown Memorial. This protocol will review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Study Start Date :
    May 1, 2009
    Actual Primary Completion Date :
    May 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      21 Years and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Any patient receiving Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh
      Exclusion Criteria:
      • Other graft material than polypropylene mesh

      • Enrollment in another study

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Atlantic Health System

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      charbel salamon, Principal Investigator, Atlantic Health System
      ClinicalTrials.gov Identifier:
      NCT01320618
      Other Study ID Numbers:
      • R09-06-003
      First Posted:
      Mar 22, 2011
      Last Update Posted:
      Aug 11, 2016
      Last Verified:
      Aug 1, 2016
      Keywords provided by charbel salamon, Principal Investigator, Atlantic Health System
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Aug 11, 2016