NCT00750035已完成不适用
Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function
St George's Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 279 人开始时间: 1996年1月1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
- 279
- 试验地点
- 2
- 主要终点
- Main outcome measure was stress incontinence
研究概览
简要总结
Background
It is uncertain whether subtotal abdominal hysterectomy results in better bladder, bowel, or sexual function than total abdominal hysterectomy.
Methods
The investigators conducted a randomized, double-blind trial comparing total and subtotal abdominal hysterectomy in 279 women referred for hysterectomy because of benign disease; most of the women were premenopausal. The main outcomes were measures of bladder, bowel, and sexual function at 12 months. The investigators also evaluated postoperative complications.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women having abdominal hysterectomy for benign conditions of the uterus
排除标准
- •Suspected cancer
- •A body weight that exceeded 100 kg
- •Previous pelvic surgery
- •Known endometriosis
- •Abnormal cervical smears,
- •Symptomatic uterine prolapse
- •Symptomatic urinary incontinence
结局指标
主要结局
Main outcome measure was stress incontinence
时间窗: Completed
次要结局
- Quality of life(Completed)
研究者
研究点 (2)
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