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

Completed · Not applicable

Conditions studied: Pelvic Organ Prolapse, Cystocele

In brief

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

Key facts

Study ID

NCT02258230

Run by

Olympus Corporation of the Americas

People needed

194

Starts

2014-12-01

Expected to finish

2018-03-01

Last updated by the study team

2018-04-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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