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One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review

This study has been completed.
Sponsor:
Information provided by:
Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01055860
First received: January 25, 2010
Last updated: March 21, 2011
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 its long-term outcomes. This advanced procedure is offered at MMH through the Urogynecology division. The Investigators setup to 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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Atlantic Health System:

Primary Outcome Measures:
  • 1. Objective anatomic outcomes We will use the pelvic organ prolapse quantification system (POP-Q). Objective surgical failure will be defined as any prolapse at or beyond the introitus [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2. Prolapse Specific Quality of Life Patients will complete a prolapse specific quality of life instrument prior to and one year after surgery. (PFIQ-7) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 3. Pelvic organ prolapse related symptoms (PFDI-20) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 4. Graft-related complications Rates of graft erosion into adjacent organs such as bowel, bladder or vagina - during the study period will be reported. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: February 2009
Study Completion Date: July 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Robotic sacral colpopexy
Our study population will be women who underwent Robotic assisted laparoscopic sacral colpopexy at the Morristown Memorial Hospital for correction of pelvic organ prolapse using a synthetic polypropylene mesh.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Our study population will be women who underwent Robotic assisted laparoscopic sacral colpopexy at the Morristown Memorial Hospital for correction of pelvic organ prolapse using a synthetic polypropylene mesh.

Criteria

Inclusion Criteria:

  • Any Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh during the study period

Exclusion Criteria:

  • Other graft material than polypropylene.
  • Enrollment in a different study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055860

Locations
United States, New Jersey
Atlantic Health Urogynecology
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
Investigators
Principal Investigator: Patrick Culligan, MD Atlantic Health System
  More Information

No publications provided

Responsible Party: Patrick Culligan, MD, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01055860     History of Changes
Other Study ID Numbers: R09-02-007
Study First Received: January 25, 2010
Last Updated: March 21, 2011
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 May 22, 2013