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NCT02258230 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02258230
Other study ID # 4859
Secondary ID
Status Completed
Phase N/A
First received October 2, 2014
Last updated April 3, 2018
Start date December 2014
Est. completion date March 2018

Study information
Verified date April 2018
Source Olympus Corporation of the Americas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 194
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• 3D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
• 2D mode of the 3D Laparoscopic Video System
Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.

Locations
Country Name City State
United States Northside Hospital Atlanta Georgia
United States Beverly Hills Sunset Surgery Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
Olympus Corporation of the Americas International Urogynecology Associates

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Operative Times Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum. Intraoperative
Secondary Complications 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
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