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ISRCTN
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ISRCTN85646253
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ClinicalTrials.gov identifier
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Public title
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Randomised pilot study of primary re-innervation of the larynx in patients undergoing vagal resection
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0025157091
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Study hypothesis
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To perform a pilot trial to assess whether dynamic methods of vagal nerve repair produce superior functional results to static repair techniques.
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Lay summary
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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 pilot 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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Surgery: Vagal resection
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Participants - inclusion criteria
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10 patients aged 16 and over undergoing resection of tumors related to the skull base where interruption of the vagus nerve is necessary to achieve tumour clearance.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/12/2004
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Anticipated end date
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01/12/2008
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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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10 patients
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Interventions
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Pilot study
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Primary outcome measure(s)
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Not provided at time of registration
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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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Aintree Hospitals NHS Trust (UK)
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Tristram Hugh John
Lesser
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Address
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AintreeTrust
University Hospital Aintree
Lower Lane
L9 7AL
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City/town
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Liverpool
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Zip/Postcode
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L9 7AL
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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18/06/2008
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Date ISRCTN assigned
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30/09/2005
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