Perspective Randomized Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair

Brief Summary

Detailed Description

Female pelvic floor disorders rank amongst the most common disorders affecting women and include conditions such as urinary incontinence and pelvic organ prolapse (POP). POP is estimated to affect 30% of women aged 50- 89 years, and the lifetime risk of requiring surgery is 11%. Open abdominal sacrocolpopexy is the established gold standard procedure and is indicated when there is prolapse of the anterior and/or apical vaginal wall compartments. Laparoscopic sacrocolpopexy (LSCP) has not been widely adopted as it demands skill and motivation and it is associated with a long learning curve. So the hypothesis is that robot-assisted laparoscopic approach for sacrocolpopexy (RALSCP) could be an alternative to a pure laparoscopic technique. In the study design 62 patients will be randomly enrolled (31 in the laparoscopic arm and 31 in the robotic assisted one). The primary outcome will be the anatomic one, secondary outcomes will be functional in terms of storage or voiding dysfunctions, sexual dysfunctions, bowel dysfunctions, QoL, post operative complications. For continuous variables will be used the Mann-Withney test, for categorical data will be used McNemar test and X2 test.

Primary Outcomes

Secondary Outcomes

• Intraoperative ando post operative complications(during surgery and within 90 days after surgery)
• post operative pain(within 7 days after surgery)
• voiding and storage symptoms(2, 6, 12 months after surgery)
• sexual dysfunctions(2, 6, 12 months after surgery)
• patient satisfaction(12 months after surgery)
• Quality of life(2, 6, 12 months)