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

Not Applicable

Completed

• Conditions: Cystocele; Pelvic Organ Prolapse
• Interventions: Device: 2D mode of the 3D Laparoscopic Video System; Device: 3D mode of the 3D Laparoscopic Video System

• Registration Number: NCT02258230
• Lead Sponsor: Olympus Corporation of the Americas

Brief 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.

Study Timeline

• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-07
• Study Start: 2014-12
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 194

Inclusion Criteria

• Symptomatic vaginal vault prolapse (stage 2 or greater point C-1 pelvic organ prolapse quantification [POP-Q] or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic sacral colpopexy

And/Or

• Symptomatic cystocele (stage 2 or greater, point Aa or Ba > -1 POP-Q or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic paravaginal repair

Exclusion Criteria

• Age less than 18 years
• Inability to comprehend questionnaires
• Inability to give informed consent or to return for review
• Vaginal vault prolapse < stage 2
• Unable to undergo general anesthesia
• More than 5 previous laparotomies
• Prior sacral colpopexy or vaginal mesh prolapse procedure
• Prior surgery involving the retropubic space
• Vaginal length less than 6 cm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2D mode LSC	2D mode of the 3D Laparoscopic Video System	2D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
2D mode PVR	2D mode of the 3D Laparoscopic Video System	2D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
3D mode LSC	3D mode of the 3D Laparoscopic Video System	3D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
3D mode PVR	3D mode of the 3D Laparoscopic Video System	3D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.

Primary Outcome Measures

Name	Time	Method
Operative Times	Intraoperative	Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum.

Secondary Outcome Measures

Name	Time	Method
Complications	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.

Trial Locations

Locations (2)

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

Beverly Hills Sunset Surgery Center; 🇺🇸 Los Angeles, California, United States