Clinical Trial: Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Laparoscopic 3D Versus 2D Sacral Colpopexy and Paravaginal Repair for Pelvic Organ Prolapse: a Comparison of Operative Times and Complications

Brief Summary: Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.

Detailed Summary: The purpose of this study is to compare operative times of laparoscopic sacral colpopexy (LSC) for the treatment of symptomatic vaginal vault prolapse as well as paravaginal repair (PVR) for symptomatic cystocele between two-dimensional and three-dimensional laparoscopic systems. Additionally this study will evaluate postoperative complications from surgeries performed using two-dimensional versus three-dimensional laparoscopic systems.
Sponsor: Olympus Corporation of the Americas

Current Primary Outcome: Operative Times [ Time Frame: Intraoperative ]

Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum.


Original Primary Outcome: Operative Times [ Time Frame: Intraoperative ]

Operative times of laparoscopic sacral colpopexy procedures from the first part of dissection until closure of the peritoneum.


Current Secondary Outcome: Complications [ Time Frame: Intraoperative up to 6 weeks post procedure ]

Intraoperative complications will be recorded. Post operative complications will be reported for the first 6 weeks after the procedure.


Original Secondary Outcome: Same as current

Information By: Olympus Corporation of the Americas

Dates:
Date Received: October 2, 2014
Date Started: December 2014
Date Completion: March 2018
Last Updated: April 27, 2017
Last Verified: April 2017