Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy

June 8, 2017 updated by: Atlantic Health System

Prospective Cohort Study Comparing Two Lightweight Y Meshes After Robotic-Assisted Laparoscopic Sacrocolpopexy Longterm Outcomes

The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

316

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
        • Department of Urogynecology-Atlantic Health System

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who had a robotic-assisted laparoscopic sacrocolpopexy using either mentioned Y-mesh during the listed timeframe. All of the index cases were performed by fellowship-trained FPMRS specialists.

Description

Inclusion Criteria:

  • All patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 to August 2011 using either Alyte Y-mesh or Restorelle Y-mesh

Exclusion Criteria:

  • Refusal to participate in our long-term outcome 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
Repair with Alyte or Restorelle Y-Mesh
Women who underwent their index robotic-assisted laparoscopic sacrocolpopexy at Morristown Medical Center or Overlook Medical Center using either the Alyte Y-mesh or Restorelle Y-smartmesh between 1/2007 and 8/2011.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Cure Rate
Time Frame: 5-6 years
To be considered a "clinical cure" subjects must meet all of the following criteria: no re-operation for or non-surgical treatment of pelvic organ prolapse since the index surgery; no symptoms of vaginal bulge as measured by a validated symptom questionnaire; no Pelvic Organ Prolapse Quantification (POP-Q) points greater than 0; POP-Q point C less than or equal to -5; an answer of "satisfied" or "very satisfied" on validated Surgical Satisfaction Questionnaire
5-6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Anatomic Outcome
Time Frame: 5-6 year
POP-Q measurements of Pelvic Organ Prolapse will be measured comparing both mesh groups and entire combined cohort compared to 12 month findings
5-6 year
Mesh exposure/erosion
Time Frame: 5-6 years
The rate of mesh exposure or erosion will be measured
5-6 years
Complications
Time Frame: 5-6 years
any other complications related to the index surgery will be documented
5-6 years
Symptom Comparison
Time Frame: 5-6 years
to compare related symptoms such as urinary frequency, bowel function, and sexual function both between mesh groups and for the entire group compared to 12 month findings
5-6 years
Surgical Satisfaction
Time Frame: 5-6 years
The validated Surgical Satisfaction Questionnaire will be used to measure overall surgical satisfaction
5-6 years

Collaborators and Investigators

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

Sponsor

Atlantic Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2014

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (ESTIMATE)

September 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 599819-2

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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