EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
研究概览
简要总结
The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.
详细描述
Uterine Artery Embolization (UAE) is a new treatment for heavy menstrual bleeding caused by uterine fibroids. UAE is already being performed on a regular basis, without profound evidence: no good quality randomized controlled trials have been conducted. The EMMY trial evaluates the safety and efficacy of UAE in a randomized comparison to hysterectomy. Patients were included when they had uterine fibroids and menorrhagia, and were eligible for hysterectomy. The primary endpoint is the elimination of menorrhagia after a two-year follow-up period. Secondary endpoints comprise: effect on complaints of pain and pressure, quality of life issues, uterine volume reduction, effect on ovarian function and cost-effectiveness. Patients were randomly assigned to either UAE or hysterectomy (1:1). All patients were followed for two years after treatment. Whether UAE can be an alternative to hysterectomy as treatment of first choice depends on the balance of efficacy, costs, and quality of life.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Uterine fibroids
- •Menorrhagia
- •Scheduled for hysterectomy
- •Pre-menopausal
排除标准
- •Childwish (planning to conceive)
- •Pregnancy
- •Suspected malignancy
- •Untreated pelvic inflammatory disease (PID)
- •Clotting disorders
- •Contrast fluid allergy
- •Presence of intrauterine device (IUD)
- •Renal failure (creatinine > 150 mmol/l)
结局指标
主要结局
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
次要结局
- Effect on complaints of pain and pressure
- Technical failure
- Complications
- Quality of life issues
- Uterine volume reduction
- Effect on ovarian function
- Cost-effectiveness
