Multicenter Study on the Correction of Prolapse Via Laparoscopy

Not Applicable

Recruiting

• Conditions: Pelvic Floor Disorders

• Registration Number: NCT06815731
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2025-01-30
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-04-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 181

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Patient preference for vaginal surgical treatment.
• Patient does not wish to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Colorectal-Anal Distress Inventory	up to 12 months	Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8
Number of patients with symptomatic failure	up to 12 months	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?"
Urinary Distress Inventory	up to 12 months	Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6.
Pelvic Organ Prolapse Distress Inventory	up to 12 months	Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6

Secondary Outcome Measures

Name	Time	Method
Intestinal and pain symptoms	up to 12 months	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	up to 12 months	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

Trial Locations

Locations (1)

HCUVA; 🇪🇸 Murcia, Spain