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…
ID
Bron
Verkorte titel
Aandoening
TCRM
Transcervical
Resection
Myoom
Myoma
Fibroid
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Reduction of menstrual blood loss (measured with Pictorial Blood Assessment Chart (PBAC)).
Achtergrond van het onderzoek
Patients are asked to fill in 3 questionnaires and keep a period diary.
Doel van het onderzoek
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).
Onderzoeksopzet
Not applicable
Onderzoeksproduct en/of interventie
Trans Cervical Resection of Myoma
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4270 |
| NTR-old | NTR4406 |
| Ander register | METC VUMC : 2013.379 |