Actively Recruiting
Multicenter Study on the Correction of Prolapse Via Laparoscopy
Led by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Updated on 2025-02-07
181
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the laparoscopic lateral suspension (LLS) technique as a way to correct anterior apical vaginal prolapse at the level of the dome or uterus. This study compares LLS with the conventional sacropexy surgical technique to determine if LLS offers similar anatomical and functional results while minimizing possible complications and making the learning curve easier for surgeons. The study focuses on women with pelvic floor disorders involving certain stages of vaginal prolapse. Participants will be randomly assigned to one of two groups: one group will receive the lateral laparoscopic suspension (LLS) procedure, and the other will undergo sacropexy without posterior mesh fixation on the puborectalis muscle. Both are surgical procedures aimed at correcting prolapse. The study will monitor patients for up to 12 months after surgery to assess outcomes. During the study, participants will be evaluated using questionnaires that measure pelvic organ prolapse symptoms, colorectal-anal distress, and urinary distress, as well as tracking the number of patients who experience symptomatic failure. Researchers will also assess intestinal and pain symptoms and anatomical results over the 12-month follow-up period. The trial excludes patients with certain surgical histories or medical conditions and focuses on adult women with specific stages of prolapse.
CONDITIONS
Brief Title
Multicenter Study on the Correction of Prolapse Via Laparoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo laparoscopic surgery to correct prolapse using either lateral laparoscopic suspension or sacropexy without posterior mesh fixation.
1 surgery visit and several immediate post-operative visits
Duration - Up to 12 months
Participants are monitored for anatomical and functional outcomes and complications following surgery.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
HCUVA
Murcia, Spain, 30120
Actively Recruiting
Research Team
M
María Luisa Sánchez Ferrer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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