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

Sponsor

Azienda Ospedaliero, Universitaria Pisana (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05856201

Collaborator

(none)

Enrollment

Arms

19.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Laparoscopic cervicosacropexy Procedure: Shull technique via V-NOTES	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

We will perform a interventional, no profit, prospective, randomized 1:1 multicentre, controlled trial with participating tertiary referral hospital centers in Italy, to compare the laparoscopic cervicosacropexy (CSP) and Shull technique via V-NOTES (VNS) in the management of apical prolapse.We will perform a interventional, no profit, prospective, randomized 1:1 multicentre, controlled trial with participating tertiary referral hospital centers in Italy, to compare the laparoscopic cervicosacropexy (CSP) and Shull technique via V-NOTES (VNS) in the management of apical prolapse.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The 6-week examination and review will be performed by the surgeon with all study data and future visits completed by blinded co-authors (Different surgeon or Urogynecology fellows) who will be unaware of group allocation.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Azienda Ospedaliero, Universitaria Pisana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tommaso Simoncini, Principal Investigator, Azienda Ospedaliero, Universitaria Pisana

ClinicalTrials.gov Identifier:

NCT05856201

Other Study ID Numbers:

V-PULSE study

First Posted:

May 12, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of May 12, 2023