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

March 21, 2011 updated by: Atlantic Health System
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health Urogynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
one year
3. Pelvic organ prolapse related symptoms (PFDI-20)
Time Frame: one year
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (ESTIMATE)

January 26, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2011

Last Update Submitted That Met QC Criteria

March 21, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R09-02-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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