Evaluating surgical outcomes for pelvic organ prolapse
Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations, a Prospective Randomised Study
This study is testing whether one type of pelvic surgery works better than another for women with pelvic organ prolapse by looking at their quality of life and any complications after the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum, Palandöken) |
| Trial ID | NCT06341088 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of unilateral versus bilateral laparoscopic suture sacro-hysteropexy operations in patients with pelvic organ prolapse. Participants will be randomly assigned to one of the two surgical approaches, and their quality of life and sexual function will be assessed before and after the procedures. The study will also evaluate surgical success rates and any complications that arise during the interventions. A computerized random number table will be utilized for randomization to ensure unbiased group allocation.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-60 with stage 3-4 pelvic organ prolapse who have not undergone previous prolapse surgery.
Not a fit: Patients outside the age range of 18-60, those with early stage prolapse, or those with a history of chronic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical techniques and outcomes for patients suffering from pelvic organ prolapse.
How similar studies have performed: While this approach has been explored in various forms, the specific comparison of unilateral versus bilateral suture sacro-hysteropexy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients between the ages of 18-60 2. No previous prolapse surgery 3. Not having a chronic disease 4. Having stage 3-4 prolapse Exclusion Criteria: 1. Outside the age range of 18-60 years 2. Previous prolapse surgery 3. Having early stage (1-2) prolapse 4. History of chronic disease
Where this trial is running
Erzurum, Palandöken
- Atatürk University — Erzurum, Palandöken, Turkey (Recruiting)
Study contacts
- Principal investigator: Gamze Nur Cimilli Senocak — Ataturk University
- Study coordinator: Gamze Nur Cimilli Senocak
- Email: gncimilli@gmail.com
- Phone: +905305880025
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.