NCT07082023

Comparison of V-NOTES and Laparoscopic Mesh-Free Sacrocolpopexy Techniques

Comparison of V-NOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Havva Betül Bacak · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the surgical outcomes, safety profiles, and patient satisfaction between two minimally invasive techniques for pelvic organ prolapse repair: Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) mesh-free sacrocolpopexy and laparoscopic mesh-free sacrocolpopexy. By evaluating perioperative data, complication rates, anatomical and functional outcomes, this trial seeks to determine whether the V-NOTES approach provides comparable or superior results to the traditional laparoscopic technique, without the use of synthetic mesh.

Detailed description

Pelvic organ prolapse (POP) is a common condition among women, especially with increasing age and parity, often requiring surgical intervention. Sacrocolpopexy is considered the gold standard for apical prolapse repair due to its high anatomical success rate and long-term durability. Traditionally performed via open or laparoscopic approaches, sacrocolpopexy has evolved with minimally invasive techniques. Recently, mesh-related complications have led to a growing interest in mesh-free alternatives. Simultaneously, natural orifice approaches such as Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) have gained popularity due to better cosmetic results, reduced postoperative pain, and faster recovery times. This prospective, comparative study aims to evaluate and compare the clinical outcomes of mesh-free sacrocolpopexy performed via V-NOTES versus the laparoscopic approach. Parameters including operative time, intraoperative and postoperative complications, hospital stay, pain scores, anatomical success, and patient satisfaction will be analyzed. The goal is to assess whether V-NOTES can be a safe and effective alternative to laparoscopic mesh-free sacrocolpopexy in the surgical management of POP.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	V-NOTES Mesh-Free Sacrocolpopexy	Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).
PROCEDURE	Laparoscopic Mesh-Free Sacrocolpopexy	Mesh-free sacrocolpopexy performed via conventional laparoscopy.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: Turkey (Türkiye)