Clinical Trial: Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University Of Perugia

Current Primary Outcome: Anatomical outcome [ Time Frame: 12 months ]

POP <2 according to POP-Q system


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intraoperative ando post operative complications [ Time Frame: during surgery and within 90 days after surgery ]
    Clavien-Dindo classification of surgery complications
  • post operative pain [ Time Frame: within 7 days after surgery ]
    VAS score (Visual Analog Pain Scale)
  • voiding and storage symptoms [ Time Frame: 2, 6, 12 months after surgery ]
    fill in Urinary Distress Inventory short form (UDI-6) to assess urinary symptoms
  • sexual dysfunctions [ Time Frame: 2, 6, 12 months after surgery ]
    fill in Female Sexual Function Index questionnaire (FSFI)
  • patient satisfaction [ Time Frame: 12 months after surgery ]
    fill in Patient Global Impression of Improvement (PGI-I)
  • Quality of life [ Time Frame: 2, 6, 12 months ]
    fill in Incontinence Impact Questionnaire-Short form (IIQ-7)


Original Secondary Outcome: Same as current

Information By: University Of Perugia

Dates:
Date Received: July 26, 2016
Date Started: March 2016
Date Completion: March 2018
Last Updated: August 3, 2016
Last Verified: August 2016