Laparoscopic Supracervical Hysterectomy With Cervicosacropexy and Vaginally Assisted NOTES Hysterectomy With Uterosacral Ligament Suspension (Shull Technique): a Randomized Multicentric Prospective Comparison Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Enrollment
- 90
- Primary Endpoint
- time to mobilization with standing
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Tommaso Simoncini
Principal Investigator
Azienda Ospedaliero, Universitaria Pisana
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.
Outcomes
Primary Outcomes
time to mobilization with standing
Time Frame: immediately post-operative
Time it takes the patient to mobilize to standing independently
hospital stay
Time Frame: immediately post-operative
hours of post-operative stay
recurrence of prolapse in the anterior and posterior compartments when present
Time Frame: at 3 months;
post-operative pain
Time Frame: at 12 hours post-operative
VAS (visual analogic scale, from 0 (minimum), to 10 (maximum pain))
postoperative complications
Time Frame: from surgery to 3 motnhs follow.up
assessed using Clavien-Dindo classification
sexual function
Time Frame: 3 months
assessed by TVL measure
recurrence of prolapse in apical compartment
Time Frame: at 6 weeks
POP-Q (Pelvic Organ Prolapse Quantification system) C point measure
anesthesiological parameters
Time Frame: intraoperative
degrees of Trendelemburg assessement
operating time
Time Frame: intraoperative
from skin/vaginal incision to end of skin/vaginal suture
patient satisfaction
Time Frame: at 3 months
assessed by validated questionnaires (VAS, visual analogic scale from 0 to 10)