TCRM study
- Conditions
- TCRMTranscervicalResectionMyoomMyomaFibroid
- Registration Number
- NL-OMON26316
- Lead Sponsor
- VUMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
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)
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of menstrual blood loss (measured with Pictorial Blood Assessment Chart (PBAC)).
- Secondary Outcome Measures
Name Time Method Reduction of menstrual pain (use of painkillers will be registered)<br>Reduction of symptoms and improvement of health related quality of life (measured with UFS QOL NL)<br>Increase in serum Hb value<br>Surgical outcome parameters, including surgery time, fluidloss, blood loss, percentage of resection, complications, recovery