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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02852512
• Other study ID #: LVR1
• Status: Recruiting
• Phase: N/A
• First received: July 26, 2016
• Last updated: August 3, 2016
• Start date: March 2016
• Est. completion date: March 2018

Study information

• Verified date: August 2016
• Source: University Of Perugia
• Contact: Elisabetta Costantini, MD
• Phone: +393393384370
• Email: elisabetta.costantini[@]unipg.it
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
Italy	Santa Maria della Misericordia Hospital- University of Perugia	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. Review. — View Citation

Seror J, Yates DR, Seringe E, Vaessen C, Bitker MO, Chartier-Kastler E, Rouprêt 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical outcome	POP <2 according to POP-Q system	12 months	No
Secondary	Intraoperative ando post operative complications	Clavien-Dindo classification of surgery complications	during surgery and within 90 days after surgery	Yes
Secondary	post operative pain	VAS score (Visual Analog Pain Scale)	within 7 days after surgery	No
Secondary	voiding and storage symptoms	fill in Urinary Distress Inventory short form (UDI-6) to assess urinary symptoms	2, 6, 12 months after surgery	No
Secondary	sexual dysfunctions	fill in Female Sexual Function Index questionnaire (FSFI)	2, 6, 12 months after surgery	No
Secondary	patient satisfaction	fill in Patient Global Impression of Improvement (PGI-I)	12 months after surgery	No
Secondary	Quality of life	fill in Incontinence Impact Questionnaire-Short form (IIQ-7)	2, 6, 12 months	No