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

NCT07082023 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-07-24

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse

Interventions

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.

Sponsors & Collaborators

  • Havva Betül Bacak

    lead OTHER_GOV

Principal Investigators

  • süleyman salman, prof · Gaziosmanpaşa Training and Research Hospital

  • havva betül bacak, md · Gaziosmanpaşa Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-01-01
Completion
2026-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07082023 on ClinicalTrials.gov