Multicenter Study on the Correction of Prolapse Via Laparoscopy

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status: Enrolling

Conditions: Pelvic Floor Disorders

Treatments: Procedure: lateral laparoscopic suspension (LLS); Procedure: Sacropexy without posterior mesh fixation on the puborrectalis muscle

Study type: Interventional

Funder types: Other

Identifiers

NCT06815731

2022-3-8-HCUVA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 181 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 2 patient groups

lateral laparoscopic suspension (LLS)

Experimental group

Treatment:

Procedure: lateral laparoscopic suspension (LLS)

Sacropexy without posterior mesh fixation on the puborrectalis muscle

Active Comparator group

Treatment:

Procedure: Sacropexy without posterior mesh fixation on the puborrectalis muscle