Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- surgery time
研究概览
简要总结
VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.
详细描述
The investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo VNOTES surgery and 30 women will undergo classic vaginal hysterectomy. The investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with vaginal prolapse
- •capable of having a surgery - assessed by an anesthesiologist
- •women who approve of having the surgery
排除标准
- •BMI over 40
- •women who have recurrent PID (pelvic inflammatory disease)
- •women with oncology records
结局指标
主要结局
surgery time
时间窗: from admission up to 6 hours post operation
time of surgery
次要结局
- PFDI score - Pelvic Floor Disability Index(from admission up to 6 hours post operation)
- hospital days(from admission up to 96 hours post operation)
- PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire(from admission up to 6 hours post operation)
- bleeding(from admission up to 6 hours post operation)
研究者
Omer MOR MD
Principle Investigator
Rambam Health Care Campus