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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура V-NOTES Mesh-Free Sacrocolpopexy
  Mesh-free sacrocolpopexy performed via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).
• Процедура Laparoscopic Mesh-Free Sacrocolpopexy
  Mesh-free sacrocolpopexy performed via conventional laparoscopy.

Первичные конечные точки

• Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months [Срок оценки: Baseline and 6 months postoperative]
• Change in PISQ-12 Score [Срок оценки: Baseline and 6 months postoperative]
• Change in Pelvic Floor Distress Inventory-20 (PFDI-20) Score [Срок оценки: Baseline and 6 months postoperative]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Gaziosmanpasa Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07082023 · gopvnotessacrocolpopexy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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