Multicenter Study on the Correction of Prolapse Via Laparoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lateral laparoscopic suspension (LLS), Sacropexy without posterior mesh fixation on the puborrectalis muscle.
- Who it may be relevant to
- Registry conditions: Pelvic Floor Disorders. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure lateral laparoscopic suspension (LLS)
lateral laparoscopic suspension (LLS) - Procedure Sacropexy without posterior mesh fixation on the puborrectalis muscle
Sacropexy without posterior mesh fixation on the puborrectalis muscle
Primary outcome measures
- Pelvic Organ Prolapse Distress Inventory [Time frame: up to 12 months]
- Colorectal-Anal Distress Inventory [Time frame: up to 12 months]
- Urinary Distress Inventory [Time frame: up to 12 months]
- Number of patients with symptomatic failure [Time frame: up to 12 months]
Secondary outcome measures (2)
- Intestinal and pain symptoms [Time frame: up to 12 months]
- Anatomical result [Time frame: up to 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- HCUVA — Murcia
Identifiers
NCT: NCT06815731 · 2022-3-8-HCUVA