Pelvic Organ Prolapse
Conditions
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.
Interventions
PROCEDURELaparoscopic cervicosacropexy
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.
PROCEDUREShull technique via V-NOTES
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.
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| operating time | intraoperative | from skin/vaginal incision to end of skin/vaginal suture |
| post-operative pain | at 4 hours post-operative | VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain)) |
| time to mobilization with standing | immediately post-operative | Time it takes the patient to mobilize to standing independently |
| hospital stay | immediately post-operative | hours of post-operative stay |
| patient satisfaction | at 6 weeks | assessed by P-QoL (prolapse quality of life) validated questionnaire |
| sexual function | at 6 weeks | assessed by FSFI (female sexual function index) questionnaire |
| recurrence of prolapse in apical compartment | at 6 weeks and 3 months; | POP-Q (Pelvic Organ Prolapse Quantification system) C point measure |
| recurrence of prolapse in the anterior and posterior compartments when present | at 3 months; | — |
| postoperative complications | from surgery to 3 motnhs follow.up | assessed using Clavien-Dindo classification |
| anesthesiological parameters | intraoperative | End tidal CO2 (carbon dioxide) assessement |
Outcome results
None listed