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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
Rambam health care campus
Haifa, Israel
Comparison of surgical time
Comparison of surgical time in single versus multi-port robotic assisted sacrocolpopexy.
Time frame: Up to four months (2 weeks before surgery until 3 months post-surgery).
Comparison of surgical success
Comparison of surgical success in single versus multi-port robotic assisted sacrocolpopexy.
Time frame: Up to four months (2 weeks before surgery until 3 months post-surgery).
Comparison of surgical complications
Comparison of surgical complications (including bleeding and post operative pain) in single versus multi-port robotic assisted sacrocolpopexy.
Time frame: Up to four months (2 weeks before surgery until 3 months post-surgery).
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