NCT02877407Unknown不适用
A Randomized Controlled Study of Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- recurrence rate (%)
研究概览
简要总结
- objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal hysterectomy for uterine prolapse
- prospective randomized clinical trial
- patient
- 60yrs or more women and
- POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
- number of patient: 146
- randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy
- follow up: postoperative 1 year
- primary endpoint: recurrence rate
- recurrence of uterovaginal prolapse POP-Q stage II-IV
- recurrence of associated symptom
- secondary endpoint
- postoperative 1 year QOL, degree of satisfaction evaluation
- operative time, estimated blood loss
- hospitalization period, postoperative pain, return to normal activity
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
排除标准
- •abnormal uterine bleeding
- •significantly enlarged fibroid uterus
- •postmenopausal uterine bleeding
- •endometrial pathology
- •on tamexifen
- •concomitant medical problems precluding general anesthesia or surgery
- •damaged agreement ability
结局指标
主要结局
recurrence rate (%)
时间窗: postoperative 1 year
recurrence rate(%) of uterovaginal prolapse POP-Q stage II-IV in postoperative 1 year
次要结局
未报告次要终点
研究者
Dong Hoon Suh
associate professor
Seoul National University Hospital
研究点 (2)
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