跳至主要内容
临床试验/NL-OMON26316
NL-OMON26316尚未招募不适用

The effect of transcervical resection of submucous fibroids in the treatment of heavy menstrual bleeding

VUMC0 个研究点目标入组 150 人开始时间: 待定最近更新:

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

发起方
VUMC

相似试验

TCRM study | 临床试验