Clinical trial NCT02852512: Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair
Official title: Perspective Randomized Trial Comparing Laparoscopic Vs Robotic-assisted Colposacropexy for Pelvic Organ Prolapse Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Laparoscopic Sacrocolpopexy
Robotic Assisted Sacrocolpopexy
Pelvic Organ Prolapse
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anatomical outcome
timeFrame: 12 months
Secondary outcomes:
measure: Intraoperative ando post operative complications
timeFrame: during surgery and within 90 days after surgery
measure: post operative pain
timeFrame: within 7 days after surgery
measure: voiding and storage symptoms
timeFrame: 2, 6, 12 months after surgery
measure: sexual dysfunctions
timeFrame: 2, 6, 12 months after surgery
measure: patient satisfaction
timeFrame: 12 months after surgery
measure: Quality of life
timeFrame: 2, 6, 12 months
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Santa Maria della Misericordia Hospital- University of Perugia
Study officials:
affiliation: University Of Perugia
name: Elisabetta Costantini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.