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

Not Applicable

Not yet recruiting

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Laparoscopic cervicosacropexy; Procedure: Shull technique via V-NOTES

• Registration Number: NCT05856201
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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).

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 Timeline

• Study First Submitted: 2023-04-20
• Status Verified: 2023-05
• Study Start: 2023-05
• Study First Submitted QC: 2023-05-03
• Last Update Submitted: 2023-05-03
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12
• Primary Completion: 2023-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic cervicosacropexy (CSP)	Laparoscopic cervicosacropexy	-
Shull technique via V-NOTES (VNS)	Shull technique via V-NOTES	-

Primary Outcome Measures

Name	Time	Method
hospital stay	immediately post-operative	hours of post-operative stay
time to mobilization with standing	immediately post-operative	Time it takes the patient to mobilize to standing independently
recurrence of prolapse in the anterior and posterior compartments when present	at 3 months;
post-operative pain	at 12 hours post-operative	VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
postoperative complications	from surgery to 3 motnhs follow.up	assessed using Clavien-Dindo classification
sexual function	3 months	assessed by TVL measure
recurrence of prolapse in apical compartment	at 6 weeks	POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
anesthesiological parameters	intraoperative	degrees of Trendelemburg assessement
operating time	intraoperative	from skin/vaginal incision to end of skin/vaginal suture
patient satisfaction	at 3 months	assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)