NL-OMON26316尚未招募不适用
The effect of transcervical resection of submucous fibroids in the treatment of heavy menstrual bleeding
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- VUMC
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •FIGO (PALM-COEIN) classification submucous uterine fibroids type 0, 1 and 2
- •Women with heavy menstrual bleeding defined as PBAC score > 150 (= 120 ml)
- •Maximum of 2 submucous fibroids
- •Maximum fibroid diameter of 4 cm
- •Residual myometrium between fibroid capsule and serosa of at least 5 mm
- •Regular cycle (with or without oral contraceptives)
排除标准
- •Age below 18 years
- •Women who do not master the Dutch or the English language
- •Congenital uterine abnormalities, except for arcuate uterus
- •Presence of FIGO (PALM-COEIN) classification type 3-4 and type 2-5 fibroids
- •Use of GnRH analogs or Ulipristal
- •Known coagulopathy or use of heparine or coumarine derivates
- •Other disorders that may induce HMB (polyps, known atypical endometrial cells, cervical dysplasia, cervical or pelvic infection, assumed malignancy, irregular cycle >35 days or intercycle variation of 2 weeks or more)
- •Contra-indications for general or spinal anaesthesia or conscious sedation
- •Women not willing to participate
研究者
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