The NAtional Trial of Tonsillectomy IN Adults (NATTINA)
Research type
Research Study
Full title
The NAtional Trial of Tonsillectomy IN Adults: a clinical and cost effectiveness study
IRAS ID
154101
Contact name
Janet Wilson
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Research summary
The role of tonsillectomy in the management of adult sore throat remains uncertain and despite compliance with Scottish Intercollegiate Guideline Network (SIGN) guidance, UK regional variation in tonsillectomy rates persists.
The questions that patients, doctors and healthcare providers wish to answer relate to the costs and benefits of tonsillectomy against conservative management (no surgery) and whether better guidelines for referring patents for a tonsillectomy can be created to maximise benefits and minimise the risks.
NATTINA is a multicentre randomised controlled surgical trial of tonsillectomy in adults with recurrent acute tonsillitis and is looking to determine the clinical and cost effectiveness of tonsillectomy versus conservative management (deferred surgery). It is taking place in 9 NHS sites within the UK.
Participants will be randomised into 2 groups in a 1:1 ratio:
• Immediate tonsillectomy (within 6-8 weeks of randomisation)
• Conservative Management consisting of usual care (deferred surgery)The study includes an internal pilot study which will assess the ability to recruit and aims to enrol 72 patients in 6 months over 6 sites. Following a successful pilot, the main trial will recruit a further 528 participants over 18 months in all 9 sites. A total of 600 participants will be recruited.
Patient, staff and GP interviews will be performed for the Qualitative Process Evaluation part of the study.
GP linkage data from participants' primary health care records will be collected to support data collected from participants during the 24 month follow up.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1144
Date of REC Opinion
10 Nov 2014
REC opinion
Further Information Favourable Opinion