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