Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jodie Komar, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01320618
First received: March 21, 2011
Last updated: August 2, 2012
Last verified: March 2011
History of Changes
  Purpose

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
Pelvic Organ Prolapse
Urinary Incontinence
Mesh Erosion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Atlantic Health System:

Enrollment: 120
Study Start Date: May 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Our study population will be woman who underwent Robotic assisted laparoscopic sacral colpopexy at the Morristown Memorial Hospital for correction of pelvic organ prolapseusing synthetic polypropelene mesh.

Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jodie Komar, PI, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01320618     History of Changes
Other Study ID Numbers: R09-06-003
Study First Received: March 21, 2011
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Atlantic Health System:
uterine prolapse
vaginal prolapse
mesh erosion
urinary incontinence
bowel symptoms

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
 Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013