Head and Neck Robotic UK study.
Research type
Research Database
IRAS ID
245473
Contact name
Emma King
Contact email
Research summary
Head and Neck Robotic UK study.
REC name
Social Care REC
REC reference
18/IEC08/0024
Date of REC Opinion
5 Nov 2018
REC opinion
Further Information Favourable Opinion
Data collection arrangements
Data will be collected after patient consent. It will be collected and retained in accordance with local laws and regulations, for example the Data Protection Act (1988) in the UK. Apart from questionnaires, the investigator (or delegated colleague) at each site is responsible for ensuring the accuracy, completeness, and timeliness of the data. Study documents will be retained in a secure location during and after the study has finished. During the study, all data will be reported in pseudonymised form and will be identified by the assigned participant number. Individual sites will only have access on ALEA to data collected via their specific site, including that which links a participant to their assigned participant number. The administrative centre will have access via ALEA to all data including the participant identifiable details, from all international sites.
Research programme
We intend to collect data from centres within the UK offering Head and Neck Robotic Surgery. There are currently 10, but this is likely to expand over time. We will collect demographic data, operative details, tumour classifiers and functional outcome (speech and swallowing). These data are normally collected by the local centres, and stored locally within the NHS. Many of these patients are recruited to national trials (i.e. PATHOS) and then these data are also transferred to the trials unit. There is currently no UK national data collection for head and neck robotic surgery patients. As a national group (British Association of Head and Neck Surgery) we are keen to collect all outcomes to help understand this specialised surgery, where it is best applied, and how to improve outcomes. Our dataset mirrors that currently collected in the US by Professor Chris Holsinger, who has kindly given us access to their datasheets, so in future, we can combine UK and US data to understand national trends and disease control in a bigger (combined) patient cohort. These data will be used to shape research ideas, inform NHS England and local commissioning groups of the use of robotic surgery in this patient cohort. These data will be presented locally, nationally and internationally. We would also anticipate publication of the data, in an open access journal.
Research database title
Head and Neck Robotic UK study.
Establishment organisation
Clinical Informatics Research Unit
Establishment organisation address
University Hospital Southampton
Mailpoint 852
NHSBT- Southampton, Coxford Road
SO16 5AF