The ACCURE-UK Trial: The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE Colitis - The ACCURE-UK Trial Feasibility study
Trial Overview
| Acronym | The ACCURE-UK Trial |
|---|---|
| Number | 56523019 |
| Protocol Link | http://www.birmingham.ac.uk/Documents/college-mds/trials/bctu/ACCURE/ACCUREUKPatientInformationSheetQualitativeInterviewsTrialNonparticipants-v2.pdf |
| Public Trial Registry Link | http://www.isrctn.com/ISRCTN56523019 |
| Status | Closed |
| Category | IBD |
| Treatment Course | Surgery |
Trial Description
| 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. |
Chief Investigator
|
Thomas Pinkney Mr |
| Profile Link |
Lead Centre
|
University Hospitals Birmingham NHS Foundation Trust Mindelsohn Way, Queen Elizabeth Medical Centre Birmingham B15 2PR UK |
| Website |
Collaboration and Funding
Collaborative Sites
| 1. Walsall Manor Hospital Moat Road Walsall WS2 9PS UK Website |
| 2. Queen Elizabeth Hospital Mindelsohn Way Birmingham B15 2TH UK Website |
| 3. Heartlands Hospital Bordesley Green East Birmingham B9 5SS UK Website |
| 4. Leicester General Hospital Gwendolen Rd Leicester LE5 4PW UK Website |
| 5. St Marks Hospital Watford Rd Harrow HA1 3UJ UK Website |
| 6. Good Hope Hospital Rectory Road Sutton Coldfield B75 7RR UK Website |
| 7. University Hospital of North Tees Hardwick Road Hardwick TS19 8PE UK Website |
Funding Sponsors
| 1. University of Birmingham NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-1112-29107 |
Additional Information
Full Research Summary| 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. |
| 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. |
| 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 |
| Reason for International Trial: | Not international, but there is a ACCURE Trial (Netherlands) |