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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
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.
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.
operating time
from skin/vaginal incision to end of skin/vaginal suture
Time frame: intraoperative
post-operative pain
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
Time frame: at 4 hours post-operative
post-operative pain
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
Time frame: at 8 hours post-operative
post-operative pain
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
Time frame: at 1 month post-operative
post-operative pain
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
Time frame: at 12 hours post-operative
time to mobilization with standing
Time it takes the patient to mobilize to standing independently
Time frame: immediately post-operative
hospital stay
hours of post-operative stay
Time frame: immediately post-operative
patient satisfaction
assessed by P-QoL (prolapse quality of life) validated questionnaire
Time frame: at 6 weeks
patient satisfaction
assessed by P-QoL validated questionnaire
Time frame: at 3 months
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patient satisfaction
assessed by PGI-I (patient global impression of improvement) validated questionnaires
Time frame: at 6 weeks
patient satisfaction
assessed by PGI-I validated questionnaires
Time frame: at 3 months
patient satisfaction
assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)
Time frame: at 6 weeks
patient satisfaction
assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)
Time frame: at 3 months
sexual function
assessed by FSFI (female sexual function index) questionnaire
Time frame: at 6 weeks
sexual function
assessed by FSFI questionnaire
Time frame: at 3 months
sexual function
assessed by TVL (total vaginal lenght) measure
Time frame: at 6 weeks
sexual function
assessed by TVL measure
Time frame: 3 months
recurrence of prolapse in apical compartment
POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
Time frame: at 6 weeks and 3 months;
recurrence of prolapse in apical compartment
POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
Time frame: at 6 weeks
recurrence of prolapse in the anterior and posterior compartments when present
Time frame: at 3 months;
postoperative complications
assessed using Clavien-Dindo classification
Time frame: from surgery to 3 motnhs follow.up
anesthesiological parameters
End tidal CO2 (carbon dioxide) assessement
Time frame: intraoperative
anesthesiological parameters
SpO2 (oxygen saturation) assessement
Time frame: intraoperative
anesthesiological parameters
blood pressure assessement (measured in mmHg)
Time frame: intraoperative
anesthesiological parameters
intraoperative blood loss assessement (measured in milliliters)
Time frame: intraoperative
anesthesiological parameters
degrees of Trendelemburg assessement
Time frame: intraoperative