Multicenter Study on the Correction of Prolapse Via Laparoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prosthetic Pelvic Organ Prolapse Repair

NCT01637441

Cystocele

COMPLETED NA

Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair.

NCT02272361

Cystocele

COMPLETED NA

Smartmesh Technology in Pelvic Floor Repair Procedures

NCT03098641

Pelvic Organ Prolapse

COMPLETED

Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse

NCT06720831

Female Genital Prolapse

RECRUITING

Study of Outpatient Management for Promontofixation by Laparoscopy

NCT03573752

Pelvic Organ Prolapse

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Floor Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

lateral laparoscopic suspension (LLS)

Group Type EXPERIMENTAL

lateral laparoscopic suspension (LLS)

Intervention Type PROCEDURE

lateral laparoscopic suspension (LLS)

Sacropexy without posterior mesh fixation on the puborrectalis muscle

Group Type ACTIVE_COMPARATOR

Sacropexy without posterior mesh fixation on the puborrectalis muscle

Intervention Type PROCEDURE

Sacropexy without posterior mesh fixation on the puborrectalis muscle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lateral laparoscopic suspension (LLS)

Intervention Type PROCEDURE

Sacropexy without posterior mesh fixation on the puborrectalis muscle

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No