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Permanent Versus Absorbable Colpopexy Trial

NCT02277925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2019-11-19

Study results available
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Summary

Primary Aim:

The primary aim of this randomized controlled trial (RCT) is to compare vaginal mesh and suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (2-0 polydioxanone, PDS) sutures through 1-year.

Secondary Aims:

1. To compare the 1-year composite success rate (leading edge of prolapse is at or above the hymen and apex has descended less than 1/3 of the vaginal length, no subjective feeling of bulge; and no retreatment for pelvic organ prolapse (POP) or vaginal mesh exposure) of permanent versus delayed absorbable sutures for mesh graft attachment during robotic total hysterectomy and sacrocolpopexy.
2. To evaluate adverse outcomes in each group

Conditions

  • Pelvic Organ Prolapse

Interventions

OTHER

Polytetrafluoroethylene

Suture used to attach mesh during sacral colpopexy surgery

OTHER

Polydioxanone

Suture used to attach mesh during sacral colpopexy surgery

Sponsors & Collaborators

  • Northwestern University

    collaborator OTHER

  • Augusta University

    collaborator OTHER

  • Wake Forest University Health Sciences

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Elizabeth Geller, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-07
Primary Completion
2019-10-07
Completion
2019-10-07

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02277925 on ClinicalTrials.gov