ACCURE-UK Feasibility Study
Research type
Research Study
Full title
The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE Colitis - The ACCURE Trial Feasibility Study
IRAS ID
139703
Contact name
Thomas Pinkney
Contact email
Duration of Study in the UK
2 years, 6 months, 3 days
Research summary
Background:
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. Research has shown that the appendix affects the development and activity of UC. 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 acceptability of this intervention to patients with relapsing UC warrants further evaluation.Methods/design
Patients with relapsing UC will be invited to participate in this feasibility study. We will randomise 48 patients to receive either standardised medical treatment or standardised medical treatment plus elective appendicectomy. The number of eligible and randomised patients in each centre will be established, as well as ascertaining optimal recruitment pathways and identifying barriers to recruitment. In-depth interviews with clinicians and patients will form an important part of these assessments. Patients undergoing appendicectomy will be closely followed to record operative details, length of stay and 30-day complication rate. Health resource usage and health-related quality of life (HRQL) information will be collected and all patients will be followed up for one-year with information about disease activity, medication use and HRQL obtained. This will provide an estimate of the control arm relapse rate as well as assessing optimal follow-up tools and likely attrition rates, hence informing the design of a potential full trial.Discussion:
If appendicectomy is an acceptable treatment option for UC patients and clinicians, we will undertake a major multicentre randomised trial to explore clinical efficacy. If appendicectomy is demonstrated to be a safe, efficacious and cost-effective strategy, widespread uptake would be anticipated.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1143
Date of REC Opinion
24 Oct 2014
REC opinion
Further Information Favourable Opinion