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

Azienda Ospedaliero, Universitaria Pisana

Status: Not yet enrolling

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Laparoscopic cervicosacropexy; Procedure: Shull technique via V-NOTES

Study type: Interventional

Funder types: Other

Identifiers

NCT05856201

V-PULSE study

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 2 patient groups

laparoscopic cervicosacropexy (CSP)

Active Comparator group

Treatment:

Procedure: Laparoscopic cervicosacropexy

Shull technique via V-NOTES (VNS)

Active Comparator group

Treatment:

Procedure: Shull technique via V-NOTES