Laparoscopic technique for correcting pelvic floor prolapse
Multicenter Study on the Correction of Prolapse Via Laparoscopy
This study is testing a new laparoscopic surgery technique for fixing pelvic floor prolapse to see if it works as well as traditional methods while causing fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 181 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia Academic / other |
| Locations | 1 site (Murcia) |
| Trial ID | NCT06815731 on ClinicalTrials.gov |
What this trial studies
This study evaluates the laparoscopic lateral suspension (LLS) technique for correcting anterior apical vaginal prolapse. It aims to assess the effectiveness of mesh fixation in providing anatomical and functional outcomes comparable to traditional surgical methods while reducing intraoperative complications. The study will involve patients with varying stages of pelvic floor disorders and will focus on the learning curve associated with sacropexy. Participants will undergo the LLS procedure without posterior mesh fixation on the puborrectalis muscle.
Who should consider this trial
Good fit: Ideal candidates are patients with Stage II-IV primary or recurrent prolapse affecting the anterior or middle vaginal compartment.
Not a fit: Patients with Stage I prolapse or those who prefer vaginal surgical treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a safer and more effective surgical option for patients with pelvic floor disorders.
How similar studies have performed: Other studies have shown promising results with laparoscopic techniques for pelvic floor disorders, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Murcia
- Hcuva — Murcia, Spain (Recruiting)
Study contacts
- Study coordinator: María Luisa Sánchez Ferrer, MD
- Email: marisasanchezferrer1@gmail.com
- Phone: 968369500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.