Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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. |
Outcome Measures
Primary Outcome Measures
- Clinical Cure Rate [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
Secondary Outcome Measures
- Objective Anatomic Outcome [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
- Mesh exposure/erosion [5-6 years]
The rate of mesh exposure or erosion will be measured
- Complications [5-6 years]
any other complications related to the index surgery will be documented
- Symptom Comparison [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
- Surgical Satisfaction [5-6 years]
The validated Surgical Satisfaction Questionnaire will be used to measure overall surgical satisfaction
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Urogynecology-Atlantic Health System | Morristown | New Jersey | United States | 07960 |
Sponsors and Collaborators
- Atlantic Health System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 599819-2