Multicenter Study on the Correction of Prolapse Via Laparoscopy

NCT06815731 | Recruiting

• 1 other identifier: 2022-3-8-HCUVA
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (4)

• Pelvic Organ Prolapse Distress Inventory

  Pelvic Organ Prolapse Distress Inventory (POPDI-6) Scores range between 0 and 24 for the POPDI-6

  up to 12 months

• Colorectal-Anal Distress Inventory

  Colorectal-Anal Distress Inventory (CRADI-8) Scores between 0 and 32 for the CRADI-8

  up to 12 months

• Urinary Distress Inventory

  Urinary Distress Inventory (UDI-6) Scores between 0 and 24 for the UDI-6.

  up to 12 months

• 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?"

  up to 12 months

Secondary Outcomes (2)

• Intestinal and pain symptoms

  up to 12 months

• Anatomical result

  up to 12 months

Study Arms (2)

lateral laparoscopic suspension (LLS)

EXPERIMENTAL

Procedure: lateral laparoscopic suspension (LLS)

Sacropexy without posterior mesh fixation on the puborrectalis muscle

ACTIVE COMPARATOR

Procedure: Sacropexy without posterior mesh fixation on the puborrectalis muscle

Interventions

lateral laparoscopic suspension (LLS) PROCEDURE

lateral laparoscopic suspension (LLS)

lateral laparoscopic suspension (LLS)

Sacropexy without posterior mesh fixation on the puborrectalis muscle PROCEDURE

Sacropexy without posterior mesh fixation on the puborrectalis muscle

Sacropexy without posterior mesh fixation on the puborrectalis muscle

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

HCUVA

Murcia, 30120, Spain

RECRUITING

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

María Luisa Sánchez Ferrer, MD

CONTACT

968369500; marisasanchezferrer1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 7, 2025
• Study Start: October 1, 2023
• Primary Completion: April 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)