| Objective: |
Ulcerative Colitis (UC) is a chronic inflammatory condition of the large bowel affecting more than 50,000 people in the UK, of whom around 40% will experience a relapse annually, with up to 25% requiring total colectomy in their lifetime. Reducing relapse and progression is a priority for patients. UC patients can be treated effectively with medical therapy, either with maintenance therapy (preventing disease relapse with 5-ASA tablet medication) or breakthrough therapy (treating active disease relapses). However, even on maintenance therapy the annual disease relapse rate is around 40% which will require escalation to high dose steroid medication with its incumbent risks and toxicity. Research has shown that the appendix affects the development and activity of UC possibly due to the appendix being a rich source of bacterial load and innate white blood cells which are important constituents of mucosal inflammation. Several small studies in patients with active UC have found that appendicectomy reduces relapse, hospitalisation and medication usage, with the potential to prevent the need for future major surgery. The aim of the ACCURE-UK study is to assess the feasibility and inform the design of a large, phase III, multi-centre randomised trial comparing standard medical therapy versus appendicectomy plus medical therapy.
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| Aim: |
The aim of the ACCURE-UK study is to assess the feasibility and inform the design of a large, phase III, multi-centre randomised trial comparing standard medical therapy versus appendicectomy plus medical therapy.
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| Methods: |
ACCURE-UK is a 48 patient feasibility 6 centre randomised controlled trial. The aim of the feasibility study is to assess the acceptability of the intervention and inform the design of a large phase III, multi-centre randomised control trial comparing standard medical therapy versus appendicectomy plus standard medical therapy. The inclusion criteria are as follows: 1. Histologically confirmed UC 2. Disease relapse within 12 months of randomisation 3. In clinical remission at time of randomisation with clinical Mayo score less than 3 and endoscopic Mayo score of 0 or 1 4. Aged at least 18 5. Able and willing to give written informed consent 6. Male & Female
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| Reason for International Trial: |
Not international, but there is a ACCURE Trial (Netherlands)
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