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TCRM study


- candidate number16126
- NTR NumberNTR4406
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2014
- Secondary IDs2013.379 METC VUMC
- Public TitleTCRM study
- Scientific TitleThe effect of transcervical resection of submucous fibroids in the treatment of heavy menstrual bleeding
- ACRONYMTCRM study
- hypothesisSubmucous 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).
- Healt Condition(s) or Problem(s) studiedFibroids, Transcervial Resection Myoma, Myoma
- Inclusion criteriaFIGO (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 criteriaAge 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2014
- planned closingdate1-mrt-2015
- Target number of participants150
- InterventionsTrans Cervical Resection of Myoma
- Primary outcomeReduction of menstrual blood loss (measured with Pictorial Blood Assessment Chart (PBAC)).
- Secondary outcomeReduction 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
- TimepointsNot applicable
- Trial web sitewww.tcrmstudie.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES A.L. Keizer
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.A.F. Huirne
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications
- Brief summaryPatients are asked to fill in 3 questionnaires and keep a period diary.
- Main changes (audit trail)
- RECORD21-jan-2014 - 4-apr-2014


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