Pelvic Organ Prolapse Clinical Trial
Official title:
Perspective Randomized Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair
The aim of the study is to perspectively compare the anatomical and functional outcomes of Pelvic Organ Prolapse (POP) repair after Laparoscopic or Robotic-assisted Colposacropexy.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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