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

Not Applicable

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: sacrocolpopexy

• Registration Number: NCT02852512
• Lead Sponsor: University Of Perugia

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-28
• Status Verified: 2016-08
• Study First Posted: 2016-08-02
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-04
• Primary Completion: 2017-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic assisted Sacrocolpopexy	sacrocolpopexy	The surgical technique will be the same between the two approaches, in this arm the approach will be robotic assisted
Laparoscopic sacrocolpopexy	sacrocolpopexy	The surgical technique will be the same between the two approaches, in this arm the approach will be laparoscopic

Primary Outcome Measures

Name	Time	Method
Anatomical outcome	12 months	POP \<2 according to POP-Q system

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Santa Maria della Misericordia Hospital- University of Perugia; 🇮🇹 Perugia, Italy