Permanent Versus Absorbable Colpopexy Trial (PACT)

Official Title: Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy: A Randomized Clinical Trial

Sponsor

Boston Scientific

Principal Investigator

Dr. Elizabeth Geller, Obstetrics and Gynecology

Project Run Dates

12/12/2014 to 04/30/2018

 

Summary

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 compare postoperative symptoms of pelvic floor disorders, including urinary incontinence, voiding dysfunction, pelvic organ prolapse, sexual dysfunction and quality of life between the 2 groups at 1 year.
  3. To evaluate adverse outcomes in each group, classified according to the Clavien-Dindo system.

 

Associated Publications and other materials

Clinical Trials.gov