Comparison of V-NOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) Mesh-Free Sacrocolpopexy and Laparoscopic Mesh-Free Sacrocolpopexy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
V-NOTES Sacrocolpopexy
Patients undergoing mesh-free sacrocolpopexy via vaginal natural orifice transluminal endoscopic surgery (V-NOTES).
干预措施: V-NOTES Mesh-Free Sacrocolpopexy (Procedure)
Laparoscopic Sacrocolpopexy
Patients undergoing mesh-free sacrocolpopexy via conventional laparoscopy.
干预措施: Laparoscopic Mesh-Free Sacrocolpopexy (Procedure)
结局指标
主要结局
Change in Pelvic Organ Prolapse Quantification (POP-Q) stage from baseline to 6 months
时间窗: 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.
Change in PISQ-12 Score
时间窗: Baseline and 6 months postoperative
Sexual function will be evaluated with PISQ-12. An increase in score indicates improvement.
Change in Pelvic Floor Distress Inventory-20 (PFDI-20) Score
时间窗: 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.
次要结局
未报告次要终点
研究者
Havva Betül Bacak
md
Gaziosmanpasa Research and Education Hospital