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

Sponsor
Olympus Corporation of the Americas (Industry)
Overall Status
Completed
CT.gov ID
NCT02258230
Collaborator
International Urogynecology Associates (Other)
194
2
4
39
97
2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: 3D mode of the 3D Laparoscopic Video System
  • Device: 2D mode of the 3D Laparoscopic Video System
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Laparoscopic 3D Versus 2D Sacral Colpopexy and Paravaginal Repair for Pelvic Organ Prolapse: a Comparison of Operative Times and Complications
Actual Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beverly Hills Sunset Surgery Center Los Angeles California United States 90069
2 Northside Hospital Atlanta Georgia United States 30342

Sponsors and Collaborators

  • Olympus Corporation of the Americas
  • International Urogynecology Associates

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Olympus Corporation of the Americas
ClinicalTrials.gov Identifier:
NCT02258230
Other Study ID Numbers:
  • 4859
First Posted:
Oct 7, 2014
Last Update Posted:
Apr 4, 2018
Last Verified:
Apr 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2018