Laparoscopic Sacrocolpopexy Versus POPS in the Surgical Management of Pelvic Organ Prolapse: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Number of patients with anatomical correction of the prolapse
研究概览
简要总结
This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
排除标准
- •Age > 70 years
- •Severe cardiovascular or respiratory disease
- •Pregnancy
- •Previous surgical procedure for POP correction
研究组 & 干预措施
Sacral colpopexy
Laparoscopic procedure
干预措施: Laparoscopic procedure (Procedure)
POPS
Laparoscopic procedure: Pelvic Organs Prolapse Suspension
干预措施: Laparoscopic procedure (Procedure)
结局指标
主要结局
Number of patients with anatomical correction of the prolapse
时间窗: up to 6 months
Anatomical correction of the prolapse evaluated by gynecological visit
次要结局
- Post operative quality of life(up to 6 months)
- Rate of recurrence(up to 6 months)
研究者
Valeria Tagliaferri
Medical Doctor
Miulli General Hospital