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

April 3, 2018 updated by: Olympus Corporation of the Americas

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90069
        • Beverly Hills Sunset Surgery Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2D mode LSC
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.
Device: 2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
Active Comparator: 3D mode LSC
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.
Device: 3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
Active Comparator: 2D mode PVR
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.
Device: 2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
Active Comparator: 3D mode PVR
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.
Device: 3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative up to 6 weeks post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olympus Corporation of the Americas

Collaborators

International Urogynecology Associates

Investigators

  • Principal Investigator: Robert D Moore, DO, International Urogynecology Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 7, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4859

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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