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ISRCTN
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ISRCTN22424487
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ClinicalTrials.gov identifier
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Public title
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A double blind RCT of selective supraomohyoid neck dissection with/without level 2b for node negative oral cancer and resulting shoulder function
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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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N0025177121
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Study hypothesis
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The aim of the project is to compare patient derived and clinician rated morbidity, in terms of shoulder function, following a selective 1-3 level neck dissection in two groups of patients randomised for inclusion of level 2b in the neck and shoulder.
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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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Cancer: Head and neck
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Participants - inclusion criteria
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1. Patients with previously untreated oral cancer arising from the floor of the mouth and anterior two thirds of tongue who are neck node negative both clinically and on MRI scan.
2. Requiring selective 1-3 level neck dissection as part of their overall treatment plan.
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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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01/01/2006
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Anticipated end date
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01/01/2009
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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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60
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Interventions
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This will be a pilot study for a double blind randomised controlled trial. 60 patients requiring selective 1-3 level neck dissection as part of their overall treatment plan would be randomised as to whether they have a level 2b or not.
Assessment will be at 3 points: baseline, six weeks post operatively and 6 months. There will be monitoring for 2 years using existing follow-up protocols for neck node recurrence. Assessment will include: neurophysiology examination, clinical examination, self-completed questionnaires.
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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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Dr
Stanley
Parikh
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Address
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AintreeTrust
University Hospital Aintree
Lower Lane
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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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Tel
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+44 0151 529 5283
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Fax
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+44 0151 529 5288
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Email
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stanp@doctors.org.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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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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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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29/09/2006
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Last edited
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09/05/2012
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Date ISRCTN assigned
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29/09/2006
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