Comparing two surgical approaches for fixing pelvic organ prolapse
Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial
This study is testing which of two surgical methods works better for fixing pelvic organ prolapse in women with moderate to severe cases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | HaEmek Medical Center, Israel Academic / other |
| Locations | 1 site (Afula) |
| Trial ID | NCT04306250 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two surgical approaches—anterior and posterior access—for apical fixation of pelvic organ prolapse in women. The study will involve women with grade 2 or above apical prolapse, assessing outcomes such as cure rates and complications associated with each surgical method. By conducting a randomized controlled trial, the researchers hope to provide clearer evidence on which approach yields better results for patients suffering from this condition. The trial is being conducted at HaEmek Medical Center in Israel.
Who should consider this trial
Good fit: Ideal candidates for this study are women with grade 2 or above apical prolapse who are symptomatic and seeking surgical treatment.
Not a fit: Patients who have contraindications for surgical treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and better quality of life for women suffering from pelvic organ prolapse.
How similar studies have performed: While there have been retrospective comparisons of the two methods, this is the first randomized controlled trial to directly compare them, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with grade 2 or above apical prolapse, according to POP Q, combined with Grade II or above of anterior wall prolapse. * Women who suffer from symptomatic POP and care for a surgical treatment Exclusion Criteria: * Women with a contra-indication for surgical treatment
Where this trial is running
Afula
- Haemek Medical Center — Afula, Israel (Recruiting)
Study contacts
- Principal investigator: meirav breverman, MD — haemek medical center
- Study coordinator: meirav breverman, MD
- Email: meirav_al@clalit.org.il
- Phone: 97246495507
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.