Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0025157091
Study information
Scientific title
Randomised pilot study of primary re-innervation of the larynx in patients undergoing vagal resection
Acronym
Study hypothesis
To perform a pilot trial to assess whether dynamic methods of vagal nerve repair produce superior functional results to static repair techniques.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled pilot trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Vagal resection
Intervention
Pilot study
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2004
Overall trial end date
01/12/2008
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10 patients
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/2004
Recruitment end date
01/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
AintreeTrust
Liverpool
L9 7AL
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Aintree Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary