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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: sacrocolpopexy

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 Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabetta Costantini, MD; Phone Number: +393393384370; Email: elisabetta.costantini@unipg.it
• Study Contact Backup: Name: Ester Illiano, MD; Phone Number: +393283620614; Email: ester.illiano@inwind.it

Study Locations

• Italy
  • Perugia, Italy, 06100
    • Recruiting
    • Santa Maria della Misericordia Hospital- University of Perugia
    • Contact: Ester Illiano, MD; Phone Number: +393283620614; Email: ester.illiano@inwind.it
    • Contact: Elisabetta Costantini, MD; Phone Number: +393393384370; Email: elisabetta.costatini@unipg.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic sacrocolpopexy; The surgical technique will be the same between the two approaches, in this arm the approach will be laparoscopic	Procedure: sacrocolpopexy; 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
Active Comparator: Robotic assisted Sacrocolpopexy; The surgical technique will be the same between the two approaches, in this arm the approach will be robotic assisted	Procedure: sacrocolpopexy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical outcome	POP <2 according to POP-Q system	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Of Perugia
• Investigators: Principal Investigator: Elisabetta Costantini, MD, University Of Perugia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Pelvic Organ Prolapse; Laparoscopic Sacrocolpopexy; Robotic Assisted Sacrocolpopexy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: LVR1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No