NCT02258230

Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Olympus Corporation of the Americas · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pelvic Organ Prolapse
• Cystocele

Interventions

Type	Name	Description
DEVICE	3D mode of the 3D Laparoscopic Video System	Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
DEVICE	2D mode of the 3D Laparoscopic Video System	Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2014-10-07
• Last updated: 2018-04-04

Locations

2 sites across 1 country: United States