NCT03034499

Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse: 1. Via single-port. 2. Via multi-port.

Detailed description

One hundred female patients diagnosed with vaginal apex prolapse will be recruited to a prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy: 1. Via single-port. 2. Via multi-port. The patients will be evaluated and randomized 2 weeks before the expected date of surgery during which eligibility will be examined. Patients' electronic files will be reviewed post operatively to acquire information regarding medical history, prolapse scores, surgical information, anesthesia information and surgical complications. Patients will have 3 week and 3 month post operative follow-up sessions to determine surgical success, late complications and patient satisfaction.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Single-port sacrocolpopexy	Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
PROCEDURE	Multi-port sacrocolpopexy	Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.

Timeline

• Start date: 2017-03-20
• Primary completion: 2018-11-01
• Completion: 2019-04-01
• First posted: 2017-01-27
• Last updated: 2019-06-11

Locations

1 site across 1 country: Israel