V-NOTES versus Laparoscopic Mesh-Free Sacrocolpopexy for Pelvic Organ Prolapse
Official title: Comparison of V-NOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy
Run by Gaziosmanpasa Research and Education Hospital · NCT07082023 · Data updated 2026-11-12
This study will test whether V-NOTES mesh-free sacrocolpopexy works as well as or better than laparoscopic mesh-free sacrocolpopexy for women with apical and anterior pelvic organ prolapse.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 52 (estimated) |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | January 1, 2026 |
| Study ends | January 1, 2026 |
| Registry record updated | July 24, 2025 |
| Trial ID | NCT07082023 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women over 18 with symptomatic apical and anterior pelvic organ prolapse (POP‑Q stage 2 or higher) who are candidates for sacrocolpopexy and can undergo surgery at Gaziosmanpaşa Training and Research Hospital are ideal candidates.
✕Probably not a fit
Patients with prior prolapse surgery, prior chemotherapy or radiotherapy for malignancy, or severe cardiovascular or respiratory disease are excluded and therefore would not be expected to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, comparative surgical study comparing two minimally invasive mesh-free techniques for apical and anterior pelvic organ prolapse repair: Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) and conventional laparoscopy. Patients will be assigned to one of the two operative approaches and perioperative metrics such as operative time, blood loss, hospital stay, and pain scores will be collected. The study will track intraoperative and postoperative complications, anatomical success by POP‑Q, functional outcomes, and patient satisfaction over follow-up. The goal is to determine whether the V-NOTES route provides comparable or superior outcomes to laparoscopic mesh-free sacrocolpopexy without using synthetic mesh.
Why it matters
Potential benefit: If successful, V-NOTES could provide comparable prolapse repair with less postoperative pain, shorter recovery, and no synthetic mesh exposure risk.
How similar studies have gone: Laparoscopic sacrocolpopexy has established long-term success, while mesh-free techniques and V-NOTES are newer approaches with promising but limited comparative data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who applied to Gaziosmanpaşa Education and Research Hospital, Gynecology and Obstetrics Clinic, who underwent surgery due to symptomatic pelvic organ prolapse with apical and anterior POP Q stage 2 and above, Being over 18 years old Patients who underwent surgery by experienced surgeons Exclusion Criteria: * Having previously received KT and/or RT due to any malignancy Having previously undergone surgery due to proplasus Patients with severe cardiovascular or respiratory disease
Where it's running
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Gaziosmanpasa Training and Research Hospital
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: havva betül bacak, md — Gaziosmanpaşa Training and Research Hospital
- Study coordinator: ecenur çelikoğlu, md
- Email: ecenurcelikoglu14@gmail.com
- Phone: +90 538 54 92 848
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.