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ISRCTN
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ISRCTN35793977
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DOI
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10.1186/ISRCTN35793977
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Trial of alternative regimens in glue ear treatment - effectiveness of surgery for otitis media with effusion in 3.5-7 year olds using multiple developmental and economic measures combined with classical clinical measures
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Scientific title
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Acronym
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TRIAL
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Serial number at source
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E203/85
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Study hypothesis
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To assess the benefit of the three main treatments for Otitis Media with Effusion (OME), i.e. Ventilation tube insertion alone, Ventilation tube insertion plus adenoidectomy, Observation + medical management- in terms of:
1. The impact upon the child's life including hearing ability, general health, behaviour and quality of life
2. The relative cost effectiveness of treatment to the NHS particularly in terms of additional benefit conferred by adenoidectomy
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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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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Hearing research
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Participants - inclusion criteria
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Children aged 3.5-7 years having had no previous ear or adenoid surgery, having B+B or B+C2 tympanograms and a bilateral average hearing threshold greater than 20 dB, plus an air-bone gap greater than 10 dB HL.
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Participants - exclusion criteria
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Children with severe general disease, cranio-facial abnormalities, sensori-neural losses, parents with language or literacy problems. A few children are also excluded if a consultant feels it would be unethical to randomise them into the study.
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Anticipated start date
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01/04/1994
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Anticipated end date
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01/12/1997
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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590
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Interventions
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1. Ventilation tube insertion alone
2. Ventilation insertion plus adenoidectomy
3. Observation + medical management
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Primary outcome measure(s)
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Clinical measures - Otoscopy, audiometry, tympanometry and questionnaire measures, (hearing and predictive factors, general health, economic impact, behavioural assessment and quality of life)
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2001 protocol in http://www.ncbi.nlm.nih.gov/pubmed/11678951
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22443163
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Contact name
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Professor
MP
Haggard
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Address
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Institute of Hearing Research
University Park
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City/town
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Nottingham
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Zip/Postcode
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NG7 2RD
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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17/10/2000
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Last edited
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19/09/2012
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Date ISRCTN assigned
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17/10/2000
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