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ISRCTN
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ISRCTN23023665
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ClinicalTrials.gov identifier
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Public title
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Multicentre randomised controlled trial comparing uterine artery embolisation with surgical treatment for uterine fibroids
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Scientific title
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Acronym
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REST
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Serial number at source
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czh/4/1
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Study hypothesis
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Compare results of embolisation with surgery for uterine fibroids.
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Lay summary
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Lay summary under review
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Ethics approval
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Ethics approval received from the Multicentre Reseach Ethics Committee (MREC) of Edinburgh on the 11th May 2000 (ref: MREC/00/0/29).
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Study design
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Open randomised controlled trial allocation 2:1 in favour of new intervention
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Uterine fibroids
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Participants - inclusion criteria
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Women with symptomatic fibroid who would normally undergo surgery for treatment.
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Participants - exclusion criteria
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1. Pregnancy
2. Unable to image with magnetic resonance imaging (MRI)
3. Fibroid size less than 2 cm
4. Subserosal fibroid on a stalk
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Anticipated start date
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01/11/2000
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Anticipated end date
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01/09/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200
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Interventions
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Uterine artery embolisation versus surgical treatment
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Primary outcome measure(s)
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The 36-item Short Form health survey (SF-36) quality of life questionnaire.
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Secondary outcome measure(s)
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1. Symptom scores
2. Complications
3. Return to lifestyle events
4. Pain scores
5. Cost analysis
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Sources of funding
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Chief Scientist Office (UK) (ref: CZH/4/1)
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Trial website
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Publications
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1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17251532
2. 2010 results in www.ncbi.nlm.nih.gov/pubmed/20465558
3. 2011 5-year results in http://www.ncbi.nlm.nih.gov/pubmed/21481151
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Contact name
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Prof
Jonathan
Moss
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Address
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Department of Radiology
Gartnavel General Hospital
1053 Great Western Road
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City/town
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Glasgow
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Zip/Postcode
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G12 OYN
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Country
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United Kingdom
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Tel
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+44 (0)141 211 3115
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Fax
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+44 (0)141 211 3471
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Email
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jon.moss@northglasgow.scot.nhs.uk
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Sponsor
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Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)
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Address
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300 Balgray Hill Road
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City/town
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Glasgow
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Zip/Postcode
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G21 3UR
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Country
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United Kingdom
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Tel
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+44 (0)141 211 1817
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Fax
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+44 (0)141 211 1814
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Email
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judith.godden@northglasgow.scot.nhs.uk
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Sponsor website:
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http://www.ngt.org
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Date applied
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08/03/2006
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Last edited
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16/05/2012
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Date ISRCTN assigned
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16/03/2006
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