Anatomic and Functional Comparison of Preoperative and Postoperative Outcomes of Mesh Free Sacrocolpopexy Performed Via Vaginal Natural Orifice Transluminal Endoscopic Surgery (VNOTES)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Pelvic Floor Distress Inventory-20 (PFDI-20) Score Change
研究概览
简要总结
This study aims to evaluate the effectiveness of mesh-free sacrocolpopexy performed using the VNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) technique in the surgical treatment of pelvic organ prolapse. Anatomical and functional outcomes will be assessed over a 6-month period before and after the operation. Evaluation tools will include the Pelvic Floor Distress Inventory-20 (PFDI-20), Pelvic Organ Prolapse Quantification (POP-Q) system, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
The findings of this study are expected to provide important data on the anatomical improvement, functional outcomes, and impact on sexual function of mesh-free sacrocolpopexy performed via the VNOTES approach.
详细描述
This prospective clinical study investigates the anatomical and functional outcomes of mesh-free sacrocolpopexy performed using the VNOTES (Vaginal Natural Orifice Transluminal Endoscopic Surgery) technique in the surgical treatment of pelvic organ prolapse. The VNOTES approach allows transvaginal access to the pelvic cavity without the need for abdominal incisions, offering the advantages of minimally invasive surgery while avoiding the use of synthetic mesh.
The study includes women diagnosed with stage II or higher pelvic organ prolapse who are candidates for sacrocolpopexy via the VNOTES technique. All participants will undergo mesh-free sacrocolpopexy performed transvaginally using endoscopic guidance.
Anatomical and functional outcomes will be evaluated using validated tools, including the Pelvic Organ Prolapse Quantification (POP-Q) system, the Pelvic Floor Distress Inventory-20 (PFDI-20), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Assessments will be performed preoperatively and at 6 months postoperatively. Intraoperative data such as operative time, estimated blood loss, complications, and length of hospital stay will also be collected.
The primary goal of the study is to assess anatomical success based on changes in POP-Q staging. Secondary outcomes include improvements in pelvic floor symptoms, sexual function, recurrence rates, and patient satisfaction.
This study aims to provide evidence on the safety, feasibility, and functional benefits of performing sacrocolpopexy without mesh through the VNOTES approach in the management of advanced pelvic organ prolapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 Gaziosmanpasa Education and Research Hospital, Gynecology and Obstetrics Clinic, have apical and anterior POP Q stage 2 and above, and have undergone surgery due to symptomatic pelvic organ prolapse, Patients who are over the age of 18 and who are citizens of the Republic of Turkey, and who have undergone surgery by experienced surgeons will be included in the study.
排除标准
- •Having previously received KT and/or RT due to any malignancy Having previously undergone surgery due to prolapse Patients with severe cardiovascular or respiratory diseases will not be included in the study.
研究组 & 干预措施
Mesh-free Sacrocolpopexy via VNOTES
Mesh-free sacrocolpopexy is performed via the VNOTES technique to treat pelvic organ prolapse. Outcomes will be evaluated before and 6 months after surgery.
干预措施: Mesh-free Sacrocolpopexy via VNOTES (Procedure)
结局指标
主要结局
Pelvic Floor Distress Inventory-20 (PFDI-20) Score Change
时间窗: Baseline to 6 months postoperative
Change in pelvic floor symptom distress measured by PFDI-20 questionnaire.
Pelvic Organ Prolapse Quantification (POP-Q) Score Change
时间窗: Baseline to 6 months postoperative
Change in anatomical prolapse stage evaluated by POP-Q scoring system.
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) Score Change
时间窗: Baseline to 6 months postoperative
Change in sexual function assessed by PISQ-12 questionnaire.
Pelvic Floor Distress Inventory-20 (PFDI-20) Score Change
时间窗: Baseline to 6 months postoperative
Change in pelvic floor symptom distress measured by PFDI-20 questionnaire.
Pelvic Organ Prolapse Quantification (POP-Q) Score Change
时间窗: Baseline to 6 months postoperative
Change in anatomical prolapse stage evaluated by POP-Q scoring system.
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) Score Change
时间窗: Baseline to 6 months postoperative
Change in sexual function assessed by PISQ-12 questionnaire.
次要结局
未报告次要终点