TCRM Transcervical Resection Myoom Myoma Fibroid
Conditions
Interventions
Trans Cervical Resection of Myoma
Sponsors
VUMC
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: Age below 18 years Women who do not master the Dutch or the English language Pregnancy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of menstrual blood loss (measured with Pictorial Blood Assessment Chart (PBAC)). | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of menstrual pain (use of painkillers will be registered) Reduction of symptoms and improvement of health related quality of life (measured with UFS QOL NL) Increase in serum Hb value Surgical outcome parameters, including surgery time, fluidloss, blood loss, percentage of resection, complications, recovery | — |
Contacts
Public ContactA.L. Keizer
VUMC PK 6Z-162 De Boelelaan 1118
Outcome results
None listed