No registrations found.
ID
Source
Brief title
Health condition
TCRM
Transcervical
Resection
Myoom
Myoma
Fibroid
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction of menstrual blood loss (measured with Pictorial Blood Assessment Chart (PBAC)).
Secondary outcome
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
Background summary
Patients are asked to fill in 3 questionnaires and keep a period diary.
Study objective
Submucous fibroids are known to be related to heavy menstrual bleeding (HMB), dysmenorrhea and fertility problems. Transcervical resection of fibroids (TCRM) is a widely implemented treatment for submucous fibroids, to be precise FIGO PALM-COEIN classification type 0, 1 and 2 fibroids. However, reduction of abnormal uterine bleeding after TCRM has never been quantified. Aim: to demonstrate reduction of heavy menstrual bleeding after TCRM (PBAC score).
Study design
Not applicable
Intervention
Trans Cervical Resection of Myoma
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4270 |
| NTR-old | NTR4406 |
| Other | METC VUMC : 2013.379 |