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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055860
First Posted: January 26, 2010
Last Update Posted: March 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Atlantic Health System
  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:


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 ]

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 ]
  • 3. Pelvic organ prolapse related symptoms (PFDI-20) [ Time Frame: one year ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Patrick Culligan, MD, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01055860     History of Changes
Other Study ID Numbers: R09-02-007
First Submitted: January 25, 2010
First Posted: January 26, 2010
Last Update Posted: March 22, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Prolapse
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical