V-NOTES versus Laparoscopic Mesh-Free Sacrocolpopexy for Pelvic Organ Prolapse
Comparison of V-NOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07082023 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Laparoscopic sacrocolpopexy has established long-term success, while mesh-free techniques and V-NOTES are newer approaches with promising but limited comparative data.
Eligibility criteria
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 this trial is running
Istanbul
- 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
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.