Status:
COMPLETED
Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair
Lead Sponsor:
Olympus Corporation of the Americas
Collaborating Sponsors:
International Urogynecology Associates
Conditions:
Pelvic Organ Prolapse
Cystocele
Eligibility:
FEMALE
18+ years
Phase:
NA
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 symptomat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT02258230
Start Date
December 1 2014
End Date
March 1 2018
Last Update
April 4 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Beverly Hills Sunset Surgery Center
Los Angeles, California, United States, 90069
2
Northside Hospital
Atlanta, Georgia, United States, 30342