Clinical trial NCT05856201: Laparoscopic Sacropexy and Vaginal Natural Orifice Transluminal Endoscopic Surgery Shull Suspension Comparison Trial
Official title: Laparoscopic Supracervical Hysterectomy With Cervicosacropexy and Vaginally Assisted NOTES Hysterectomy With Uterosacral Ligament Suspension (Shull Technique): a Randomized Multicentric Prospective Comparison Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: operating time
timeFrame: intraoperative
measure: post-operative pain
timeFrame: at 4 hours post-operative
measure: post-operative pain
timeFrame: at 8 hours post-operative
measure: post-operative pain
timeFrame: at 1 month post-operative
measure: post-operative pain
timeFrame: at 12 hours post-operative
measure: time to mobilization with standing
timeFrame: immediately post-operative
measure: hospital stay
timeFrame: immediately post-operative
measure: patient satisfaction
timeFrame: at 6 weeks
measure: patient satisfaction
timeFrame: at 3 months
measure: patient satisfaction
timeFrame: at 6 weeks
measure: patient satisfaction
timeFrame: at 3 months
measure: patient satisfaction
timeFrame: at 6 weeks
measure: patient satisfaction
timeFrame: at 3 months
measure: sexual function
timeFrame: at 6 weeks
measure: sexual function
timeFrame: at 3 months
measure: sexual function
timeFrame: at 6 weeks
measure: sexual function
timeFrame: 3 months
measure: recurrence of prolapse in apical compartment
timeFrame: at 6 weeks and 3 months;
measure: recurrence of prolapse in apical compartment
timeFrame: at 6 weeks
measure: recurrence of prolapse in the anterior and posterior compartments when present
timeFrame: at 3 months;
measure: postoperative complications
timeFrame: from surgery to 3 motnhs follow.up
measure: anesthesiological parameters
timeFrame: intraoperative
measure: anesthesiological parameters
timeFrame: intraoperative
measure: anesthesiological parameters
timeFrame: intraoperative
measure: anesthesiological parameters
timeFrame: intraoperative
measure: anesthesiological parameters
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: