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NCT Number: NCT07082023

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

ecenur md çelikoğlu

SUB_INVESTIGATOR

süleyman salman

CONTACT

[email protected]

+905059345470

yağmur md acıyiyen

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V-NOTES Mesh-Free Sacrocolpopexy

Procedure

Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).

Laparoscopic Mesh-Free Sacrocolpopexy

Procedure

Mesh-free sacrocolpopexy performed via conventional laparoscopy.

Primary outcomes

  1. Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months

    Time frame: Baseline and 6 months postoperative

    Anatomical success will be evaluated using the POP-Q system. A reduction of prolapse stage by at least one level or achieving stage 0-1 will be considered successful.

  2. Change in PISQ-12 Score

    Time frame: Baseline and 6 months postoperative

    Sexual function will be evaluated with PISQ-12. An increase in score indicates improvement.

  3. Change in Pelvic Floor Distress Inventory-20 (PFDI-20) Score

    Time frame: Baseline and 6 months postoperative

    Patient-reported symptoms related to pelvic floor distress will be evaluated using the PFDI-20. A decrease in score indicates improvement in symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

ecenur çelikoğlu, md

CONTACT

[email protected]

+90 538 54 92 848

yağmur acıyiyen, md

CONTACT

[email protected]

+90 542 566 9593

Sponsors and collaborators

Lead sponsor

Havva Betül Bacak

Other Gov

Registry information

Official study title

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

Acronym: vnotes

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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