Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02248935

Enrollment

316

Registered

2014-09-25

Start date

2014-07-31

Completion date

2015-08-31

Last updated

2017-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

Robotic Assisted Laparoscopic Sacrocolpopexy, Y Mesh, Pelvic Organ Prolapse

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results