ACCURE-UK 2
Research type
Research Study
Full title
An international multicentre randomised controlled trial to assess the effect of Appendectomy on the Clinical Course of ulcerative colitis; UK Arm
IRAS ID
254954
Contact name
Birgit Whitman
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Ulcerative colitis (UC) is a form of inflammatory bowel disease. Symptoms of the disease include diarrhoea, abdominal pain and an increase in the need to use the toilet. Patients can go for months with no, or very mild symptoms (remission) and then suffer a flare up (relapse) where symptoms become much more severe; hospital treatment can become necessary in the worse cases. There is some evidence that the appendix has a role in the regulation of inflammation within the bowel, and that removing the appendix (appendicectomy, also commonly known as appendectomy in Europe/the US) may have a positive impact on how active UC is. Results from our previous pilot study also show that appendicectomy is safe and attractive to patients and their doctors and had better outcomes. However, the pilot study was not designed to be large enough to prove any definite benefit. ACCURE-UK 2 is a larger clinical study to compliment a study currently being carried out in The Netherlands, using the same design and study procedures. This will allow us to combine our findings with the Dutch group in one large analysis, thereby obtaining a more robust result and in a more timely fashion. This UK study will recruit 90 UC patients currently in disease remission and randomly allocate them into one of two groups, the appendicectomy group or the control group. Those in the control group take their standard tablet medication as usual. Those in the appendicectomy group also take their usual medication but they also undergo an appendicectomy. All patients will then be followed up for one-year with information about disease activity, medication use, health-related quality of life, health resource usage obtained. If appendicectomy can be shown to improve symptoms in UC, widespread uptake is anticipated.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0191
Date of REC Opinion
1 Aug 2019
REC opinion
Further Information Favourable Opinion