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

Olympus

Status: Completed

Conditions: Cystocele; Pelvic Organ Prolapse

Treatments: Device: 3D mode of the 3D Laparoscopic Video System; Device: 2D mode of the 3D Laparoscopic Video System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02258230

4859

Details and patient eligibility

About

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

Full 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.

Enrollment: 194 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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194 participants in 4 patient groups

2D mode LSC

Active Comparator group

Description:

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.

Treatment:

Device: 2D mode of the 3D Laparoscopic Video System

3D mode LSC

Active Comparator group

Description:

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.

Treatment:

Device: 3D mode of the 3D Laparoscopic Video System

2D mode PVR

Active Comparator group

Description:

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.

Treatment:

Device: 2D mode of the 3D Laparoscopic Video System

3D mode PVR

Active Comparator group

Description:

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.

Treatment:

Device: 3D mode of the 3D Laparoscopic Video System