Multicenter Study on the Correction of Prolapse Via Laparoscopy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • lateral laparoscopic suspension (LLS)

    Procedure/Surgery

    lateral laparoscopic suspension (LLS)

  • Sacropexy without posterior mesh fixation on the puborrectalis muscle

    Procedure/Surgery

    Sacropexy without posterior mesh fixation on the puborrectalis muscle

Treatment groups

181 Participants
are divided into 2 treatment groups
Group A: lateral laparoscopic suspension (LLS)Experimental treatment 1 intervention
Group B: Sacropexy without posterior mesh fixation on the puborrectalis muscleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pelvic Organ Prolapse Distress Inventory

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

Time frame
up to 12 months
2

Colorectal-Anal Distress Inventory

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

Time frame
up to 12 months
3

Urinary Distress Inventory

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

Time frame
up to 12 months
4

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?"

Time frame
up to 12 months

Secondary outcomes

1

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.

Time frame
up to 12 months
2

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

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.