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ALYTE: A Study of Robotic Assisted Laparoscopic Sacral Colpopexy Using Alyte Mesh

Sponsor
Atlantic Health System (Other)
Overall Status
Completed
CT.gov ID
NCT01320644
Collaborator
(none)
150
Enrollment
1
Location
24
Duration (Months)
6.2
Patients Per Site Per Month

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 outcomes. This advanced procedure is offered at Morristown Memorial. THis protocol will review the one year outcome of patients who underwent this pocedure using a polypropylene mesh. These outcomes will incude anatomical and quality of life measures.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Study Start Date :
    Aug 1, 2010
    Actual Primary Completion Date :
    Aug 1, 2012
    Actual Study Completion Date :
    Aug 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    vaginal mesh placement

    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 copopexy with polypropylene mesh

      • 21 y.o

      Exclusion Criteria:

      • Graft material other than polypropylene mesh

      • Enrollment in another study

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Morristown Memorial Hospital 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:
      charbel salamon, Principal Investigator, Atlantic Health System
      ClinicalTrials.gov Identifier:
      NCT01320644
      Other Study ID Numbers:
      • R10-06-005
      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
      Uterine prolapse
      vaginal prolapse
      mesh erosion
      urinary incontinence
      bowel symptoms
      Additional relevant MeSH terms:
      Urinary Incontinence
      Enuresis
      Prolapse
      Pelvic Organ Prolapse

      Study Results

      No Results Posted as of Aug 11, 2016