About this trial
In the laparoscopic lateral suspension (LLS) technique, the fixation of the mesh as a prosthetic element for correcting anterior apical vaginal prolapse at the level of the dome or uterus can offer anatomical and functional results that are not inferior to those of the conventional surgical technique, minimize possible intraoperative complications and facilitate the specific learning curve of sacropexy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with Stage II- IV primary or recurrent prolapse affecting the anterior or middle vaginal compartment with or without minimal posterior defect (Stage I) according to the POP-Q.
Disqualifiers
History of abdominal prolapse reconstructive surgery.
History of prolapse reconstructive surgery with vaginal meshes.
Stage I according to the POP-Q classification or asymptomatic prolapse.
Medical contraindication for general anaesthesia.
Trial design
Parallel
Treatments tested in this trial
lateral laparoscopic suspension (LLS)
Procedure/Surgerylateral laparoscopic suspension (LLS)
Sacropexy without posterior mesh fixation on the puborrectalis muscle
Procedure/SurgerySacropexy without posterior mesh fixation on the puborrectalis muscle
Treatment groups
Trial outcomes
Primary outcomes
Pelvic Organ Prolapse Distress Inventory
Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6
Colorectal-Anal Distress Inventory
Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8
Urinary Distress Inventory
Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6.
Number of patients with symptomatic failure
Number of patients with symptomatic failure , defined as a positive response (accompanied by any degree of discomfort) to the following question on the validated questionnaire regarding prolapse symptoms (PFDI-20): "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?"
Secondary outcomes
Intestinal and pain symptoms
Subjective or functional success is defined as an improvement of ≥15 points per domain (the minimally important difference) or a decrease in the total score of 45 points (the minimally important difference). The PISQ-2 questionnaire has a score range between 0 and 48, and a difference ≥ 6 points is considered a minimally important difference.
Anatomical result
Anatomical results are defined as any POP-Q measurement below the hymen. Anatomical variables of prolapse: POPQ classification : * Anterior compartment: Aa, Ba * Middle compartment: C or D * Posterior compartment: Ap, Bp
Sponsors and contacts
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