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

NCT05856201 | Unknown

• 1 other identifier: V-PULSE study
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (26)

• 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

Study Arms (2)

laparoscopic cervicosacropexy (CSP)

ACTIVE COMPARATOR

Procedure: Laparoscopic cervicosacropexy

Shull technique via V-NOTES (VNS)

ACTIVE COMPARATOR

Procedure: Shull technique via V-NOTES

Interventions

Laparoscopic cervicosacropexy PROCEDURE

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.

laparoscopic cervicosacropexy (CSP)

Shull technique via V-NOTES PROCEDURE

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.

Shull technique via V-NOTES (VNS)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 12, 2023
• Study Start: May 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share