Laparoscopic Sacropexy and Vaginal Natural Orifice Transluminal Endoscopic Surgery Shull Suspension Comparison Trial (V-PULSE)

Laparoscopic Supracervical Hysterectomy With Cervicosacropexy and Vaginally Assisted NOTES Hysterectomy With Uterosacral Ligament Suspension (Shull Technique): a Randomized Multicentric Prospective Comparison Trial

This is a prospective, randomized multicenter study whose objective is to compare two surgical techniques routinely used at our center for the correction of pelvic organ prolapse (laparoscopic cervicosacropexis versus colposuspension sec. Shull using v-NOTES).

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Laparoscopic cervicosacropexy; Procedure: Shull technique via V-NOTES

Detailed Description

patients with pelvic organ prolapse with a stage greater than or equal to stage 2 for the apical compartment who are candidates for surgical correction will be randomized and assigned to one of two treatment groups. The aim is to compare the anatomical, surgical and anesthesiological outcomes between these two surgical techniques, both of which are commonly used in clinical practice for the correction of this type of prolapse.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• consecutive women referred to one of the participating centers with symptomatic stage 2 or greater (point C≥ -1 pelvic organ prolapse quantification POP-Q) apical prolapse (uterovaginal) with or without anterior and posterior compartment prolapse will be eligible for inclusion (Criteria for which patients in clinical practice are candidates for one of the two interventions under study)

Exclusion Criteria:

• age <18 years, BMI > 30,
• previous hysterectomy,
• inability to comprehend questionnaires, to give informed consent and to return for review,
• unable to undergo general anesthesia,
• prior laparoscopic prolapse repair or vaginal mesh prolapse procedure,
• desire for future pregnancy or current pregnancy diagnosis
• severe respiratory comorbidity,
• ASA III patients,
• need for concomitant anti-incontinence procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laparoscopic cervicosacropexy (CSP)	Procedure: Laparoscopic cervicosacropexy; The first step consists of a supracervical hysterectomy with morcellation. Anterior and posterior dissection of the vesicovaginal and rectovaginal space. Placing a flexible blade or a Breisky blade in the vagina which is manipulated by the assistant in order to improve exposure of the tissue planes. The retroperitoneum will then be opened from sacral promontory to cervix with the incision just medial to the uterosacral ligament. A low-weight preshaped Y-shaped polypropylene mesh will be secured to the anterior and posterior vagina with four to six separated absorbable 2.0 polyglactin sutures and two nonabsorbable 2.0 prolene sutures can be placed at the level of the remaining cervix. The mesh will be attached to the sacral promontory using two or three nonabsorbable monofilament 2.0 prolene suture. The retroperitoneal space will be closed with continuous 2.0 polyglactin suture or barbed 2.0 absorbable suture material.
Active Comparator: Shull technique via V-NOTES (VNS)	Procedure: Shull technique via V-NOTES; Using a cold-bladed scalpel, pericervical colpotomy and subsequent opening of the Douglas and vesico-uterine space is performed. The following step is forcipressure and section of uterosacral ligaments bilaterally with cold blade scissors and ligation in Polysorb 0. A v-PATH® wall retractor is placed, after insertion of three trocars. Total hysterectomy is then performed by standard V-NOTES technique. After transperitoneal visualization of the ureters bilaterally, the peritoneum is incised between the ureters and the uterosacral ligaments, which are thus bilaterally isolated, and three points in polydioxanone 2/0 are placed per side. The v-PATH wall retractor is then removed. Finally the suspension of the vaginal vault at the uterosacral ligaments is made according to Shull technique. Eventual fascial corrections of concomitant anterior or posterior defects will be associated if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operating time	from skin/vaginal incision to end of skin/vaginal suture	intraoperative
post-operative pain	VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))	at 4 hours post-operative
post-operative pain	VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))	at 8 hours post-operative
post-operative pain	VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))	at 1 month post-operative
post-operative pain	VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))	at 12 hours post-operative
time to mobilization with standing	Time it takes the patient to mobilize to standing independently	immediately post-operative
hospital stay	hours of post-operative stay	immediately post-operative
patient satisfaction	assessed by P-QoL (prolapse quality of life) validated questionnaire	at 6 weeks
patient satisfaction	assessed by P-QoL validated questionnaire	at 3 months
patient satisfaction	assessed by PGI-I (patient global impression of improvement) validated questionnaires	at 6 weeks
patient satisfaction	assessed by PGI-I validated questionnaires	at 3 months
patient satisfaction	assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)	at 6 weeks
patient satisfaction	assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)	at 3 months
sexual function	assessed by FSFI (female sexual function index) questionnaire	at 6 weeks
sexual function	assessed by FSFI questionnaire	at 3 months
sexual function	assessed by TVL (total vaginal lenght) measure	at 6 weeks
sexual function	assessed by TVL measure	3 months
recurrence of prolapse in apical compartment	POP-Q (Pelvic Organ Prolapse Quantification system) C point measure	at 6 weeks and 3 months;
recurrence of prolapse in apical compartment	POP-Q (Pelvic Organ Prolapse Quantification system) C point measure	at 6 weeks
recurrence of prolapse in the anterior and posterior compartments when present		at 3 months;
postoperative complications	assessed using Clavien-Dindo classification	from surgery to 3 motnhs follow.up
anesthesiological parameters	End tidal CO2 (carbon dioxide) assessement	intraoperative
anesthesiological parameters	SpO2 (oxygen saturation) assessement	intraoperative
anesthesiological parameters	blood pressure assessement (measured in mmHg)	intraoperative
anesthesiological parameters	intraoperative blood loss assessement (measured in milliliters)	intraoperative
anesthesiological parameters	degrees of Trendelemburg assessement	intraoperative

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Universitaria Pisana

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: V-PULSE study

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No