Rabbit In 'RABBIT' For InvestigatorsPrivacyRABBITRABBIT In The MediaRecruitment and participating centresContact us The Rabbit Trial is looking at the clinical and cost effectiveness of Radiofrequency Ablation for Benign Intrathyroidal Tumours Trial Documentation These documents are for use by collaborators involved in the Rabbit Trial. They are the property of the University of Birmingham and do not constitute any form of advice to participants. Please contact us on this link if you require printed versions of any of these documents: Rabbit@trials.bham.ac.uk Protocol (Click to download) Participant Information Sheet (Click to download) Design A pragmatic, multicentre, open label, randomised non-inferiority trial, with 1:1 randomisation, preceded by an internal pilot phase and a health economic evaluation. Aim of the Study To examine the efficacy of radiofrequency ablation versus conventional open hemithyroidectomy for symptom reduction, complications, cost effectiveness and overall acceptability. Setting Secondary/Tertiary Care thyroid surgery/endocrinology departments in approximately 20 UK centres. Target Population 448 patients aged 18 years or older with single or multiple thyroid nodule(s) that are causing compressive or cosmetic symptoms affecting their quality of life. Intervention Radiofrequency ablation versus conventional open hemithyroidectomy. Outcomes Primary Outcomes 1. Goitre symptom score at 12 months post intervention - determined by the goitre domain of the ThyPRO tool (Thyroid specific patient reported outcome tool) 2. Cost effectiveness at 12 months Secondary Outcomes Clinical Composite ThyPRO score (overall quality of life) at 12 months post intervention ThyPROdomain scores for: hyperthyroid symptoms, hypothyroid symptoms, eye symptoms, tiredness, cognition, anxiety, depressivity, emotional susceptibility, impaired social life, impaired daily life, impaired sex life and cosmetic complaints. All at 3, 12, 24 and 36 months post intervention. Incidence of complications within 3 months post intervention Incidence of hypothyroidism up to 36 months post intervention Incidence of temporary or permanent recurrent laryngeal nerve palsy at 12 months post intervention Percentage volume reduction in treated nodule(s) at 12 months post intervention (RFA arm only) Need for additional procedures related to the condition or treatment received up to 36 months post intervention Nodule recurrence at 36 months post intervention assessed by USS (RFA arm only) Pain intensity (related to pre-existing pain levels and the procedure – measured using pain VAS) at immediately post-intervention, 3, 12, 24, and 36 months post intervention Related re-admission to hospital within 30 days of the initial trial intervention Economic Cost-effectiveness at 12 months Health related quality of life (using the EQ-5D-5L) Health resource usage (HRUQ) Other Acceptibility of RFA to patients (determined by take-up at screening) Funding The RABBIT trial is funded by a National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme grant.