Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy
Prospective Cohort Study Comparing Two Lightweight Y Meshes After Robotic-Assisted Laparoscopic Sacrocolpopexy Longterm Outcomes
1 other identifier
observational
316
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJune 9, 2017
June 1, 2017
1.1 years
August 25, 2014
June 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Cure Rate
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 Outcomes (5)
Objective Anatomic Outcome
5-6 year
Mesh exposure/erosion
5-6 years
Complications
5-6 years
Symptom Comparison
5-6 years
Surgical Satisfaction
5-6 years
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- All patients who underwent robotic-assisted laparoscopic sacrocolpopexy between January 2007 to August 2011 using either Alyte Y-mesh or Restorelle Y-mesh
You may not qualify if:
- Refusal to participate in our long-term outcome study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urogynecology-Atlantic Health System
Morristown, New Jersey, 07960, United States
Related Publications (1)
Culligan PJ, Lewis C, Priestley J, Mushonga N. Long-Term Outcomes of Robotic-Assisted Laparoscopic Sacrocolpopexy Using Lightweight Y-Mesh. Female Pelvic Med Reconstr Surg. 2020 Mar;26(3):202-206. doi: 10.1097/SPV.0000000000000788.
PMID: 31688526DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2014
First Posted
September 25, 2014
Study Start
July 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
June 9, 2017
Record last verified: 2017-06