NCT03722563已完成不适用
Comparison of Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse: a Randomized Clinical Trial
Antalya Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年1月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Rate of objective cure
研究概览
简要总结
This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and/or apical (central) compartment that require surgical management
排除标准
- •Patients that are not candidates for general anesthesia or laparoscopy
- •Inability to consent
- •history of hysterectomy
- •history of anterior or apical pelvic organ prolapse surgery
- •history of urinary incontinence surgery
- •pregnancy or breast-feeding during the study period
- •suspicious adnexal masses or other factors that may indicate pelvic malignancy
结局指标
主要结局
Rate of objective cure
时间窗: 12 months
Recurrences of vaginal vault prolapse will be assessed as objective cure by using the pelvic organ prolapse quantification (POP-Q) system
次要结局
- Patient Global Impression of Improvement (PGI-I)(12 months)
- International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)(12 months)
- International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS)(12 months)
研究者
bekirsitkiisenlik
principal investigator
Antalya Training and Research Hospital
研究点 (2)
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