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

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.

The surgical technique will be the same between the two approaches, in this arm the approach will be laparoscopic

The surgical technique will be the same between the two approaches, in this arm the approach will be robotic assisted

Peritoneal incision from the sacral promontory to the Pouch of Douglas. After careful dissection of the inter-rectovaginal space, a two-piece Y-shaped polypropylene mesh was fixed posteriorly to the levator ani muscles using a absorbable suture. The midpoint of the mesh is anchored to the posterior wall of the vagina. The anterior portion of mesh was then introduced and fixed within the intervesico- vaginal space to the anterior/apical vaginal wall with a running suture. The tails of both meshes were fixed to the sacral promontory with a strong non-absorbable polypropylene suture. The peritoneal incision was re- approximated with a running absorbable suture

Inclusion Criteria: Symptomatic POP >2 stage according to POP Q system Exclusion Criteria: Obesity Heart failure (NYHA III-IV) High stage COPD (Chronic Obstructive Pulmonary Disease) Patients who underwent more than 2 previous abdominal surgical procedures

Lee RK, Mottrie A, Payne CK, Waltregny D. A review of the current status of laparoscopic and robot-assisted sacrocolpopexy for pelvic organ prolapse. Eur Urol. 2014 Jun;65(6):1128-37. doi: 10.1016/j.eururo.2013.12.064. Epub 2014 Jan 8.

Seror J, Yates DR, Seringe E, Vaessen C, Bitker MO, Chartier-Kastler E, Roupret M. Prospective comparison of short-term functional outcomes obtained after pure laparoscopic and robot-assisted laparoscopic sacrocolpopexy. World J Urol. 2012 Jun;30(3):393-8. doi: 10.1007/s00345-011-0748-2. Epub 2011 Aug 20.

Awad N, Mustafa S, Amit A, Deutsch M, Eldor-Itskovitz J, Lowenstein L. Implementation of a new procedure: laparoscopic versus robotic sacrocolpopexy. Arch Gynecol Obstet. 2013 Jun;287(6):1181-6. doi: 10.1007/s00404-012-2691-x. Epub 2012 Dec 30.