Laparoscopic Sacropexy and Vaginal Natural Orifice Transluminal Endoscopic Surgery Shull Suspension Comparison Trial

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Laparoscopic cervicosacropexy
* Procedure: Shull technique via V-NOTES


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic cervicosacropexy (CSP)<br> | Procedure: Laparoscopic cervicosacropexy<br>* 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.<br>|
| Active Comparator: Shull technique via V-NOTES (VNS)<br> | Procedure: Shull technique via V-NOTES<br>* 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.<br>|

What is the study measuring?
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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 |