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

Primary Purpose

Pelvic Organ Prolapse, Cystocele

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

3D mode of the 3D Laparoscopic Video System

2D mode of the 3D Laparoscopic Video System

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Beverly Hills Sunset Surgery Center
Northside Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

2D mode LSC

3D mode LSC

2D mode PVR

3D mode PVR

Arm 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.

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.

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 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.

Outcomes

Primary Outcome Measures

Operative Times

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

Secondary Outcome Measures

Complications

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

Full Information

NCT ID

NCT02258230

First Posted

October 2, 2014

Last Updated

April 3, 2018

Sponsor

Olympus Corporation of the Americas

Collaborators

International Urogynecology Associates

1. Study Identification

Unique Protocol Identification Number

NCT02258230

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

December 2014 (Actual)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Olympus Corporation of the Americas

Collaborators

International Urogynecology Associates

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse, Cystocele

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

194 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2D mode LSC

Arm Type

Active Comparator

Arm 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.

Arm Title

3D mode LSC

Arm Type

Active Comparator

Arm 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.

Arm Title

2D mode PVR

Arm Type

Active Comparator

Arm 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.

Arm Title

3D mode PVR

Arm Type

Active Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

3D mode of the 3D Laparoscopic Video System

Intervention Description

Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

Intervention Type

Device

Intervention Name(s)

2D mode of the 3D Laparoscopic Video System

Intervention Description

Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

Primary Outcome Measure Information:

Title

Operative Times

Description

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

Time Frame

Intraoperative

Secondary Outcome Measure Information:

Title

Complications

Description

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

Time Frame

Intraoperative up to 6 weeks post procedure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert D Moore, DO

Organizational Affiliation

International Urogynecology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beverly Hills Sunset Surgery Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90069

Country

United States

Facility Name

Northside Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.miklosandmoore.com/

Description

International Urogynecology Associates' website

Learn more about this trial

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

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