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临床试验/NCT00100191
NCT00100191已完成3 期

EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids

ZonMw: The Netherlands Organisation for Health Research and Development3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2002年2月1日最近更新:
适应症

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

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

研究者

发起方
ZonMw: The Netherlands Organisation for Health Research and Development
申办方类型
Other

研究点 (3)

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