Comparing two surgical techniques for pelvic organ prolapse
Comparison of Early Postoperative Outcomes of Patients Undergoing Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension With the Salman Ketenci Gencer Technique
This study is testing two different surgical methods for treating severe pelvic organ prolapse to see which one works better and is safer for sexually active patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06802497 on ClinicalTrials.gov |
What this trial studies
This study compares the early postoperative outcomes of two surgical techniques for treating pelvic organ prolapse: laparoscopic lateral suspension and V-NOTES lateral suspension using the Salman Ketenci Gencer technique. It aims to evaluate the effectiveness and safety of these approaches in patients with advanced stages of prolapse. The study is observational, meaning it will analyze outcomes without assigning specific interventions to participants. The focus is on sexually active patients with stage 3 or 4 pelvic organ prolapse.
Who should consider this trial
Good fit: Ideal candidates are sexually active patients diagnosed with stage 3 or 4 pelvic organ prolapse.
Not a fit: Patients with cervical pathology, a history of certain surgical procedures, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical technique for improving postoperative outcomes in patients with pelvic organ prolapse.
How similar studies have performed: While this study focuses on a specific comparison, similar surgical techniques have shown promise in treating pelvic organ prolapse, suggesting potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with stage 3 or 4 pelvic organ prolapse Sexually active patients Exclusion Criteria: * Cervical pathology History of loop electrosurgical excision procedure (LEEP) or conization Presence of vaginal, pelvic, or adnexal mass Suspicious abdominal malignancy Morbid obesity Any pelvic infection Signs of pregnancy
Where this trial is running
Istanbul
- Gaziosmanpaşa Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Fatma Ketenci Gencer, Associate Professor
- Email: fathma_k@hotmail.com
- Phone: +905416116469
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.