Extrait

Background and study aims Ulcerative colitis (UC) is a form of inflammatory bowel disease. It is a long-term condition that results in ulcers on the internal surface of the bowel which can bleed and produce pus. Symptoms of the disease include diarrhoea (which may contain blood, mucus and/or pus), 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. Most UC patients remain on long-term medication to maintain their lifestyle and prevent flare-ups of disease. Even so, over one third of patients who have had a flare-up of their disease will suffer from another attack within the following twelve months. If this happens, many will need to take more medication, including taking steroids. These flare-ups also effect patients' ability to work and look after children, as well as on their overall quality of life. Doctors are constantly looking for new ways to manage the condition, including developing new drugs to try to prevent or limit disease flare-ups. There is some evidence that the appendix has a role in the regulation of inflammation within the bowel, and that removing the appendix may have a positive impact on how active UC is. This evidence is not yet strong enough to recommend that all patients with UC would benefit from having their appendix removed. We feel that this is an interesting and exciting potential treatment option, and aim to explore it further within this research. Here, we want to find out whether removing the appendix (appendicectomy) can reduce the chances of UC flare-ups. We are going to look at whether it's an attractive treatment to offer to UC sufferers, both from the patients' and the doctors' point of view. If we can successfully recruit patients to this trial, and review them regularly throughout the one year period afterwards, we plan to undertake a follow-on trial in the future to establish exactly how beneficial this treatment is in a larger group of UC patients. Who can participate? Adult patients (aged at least 18) that have been diagnosed with UC, currently in remission but have had a disease flare-up within the last 12 months. What does the study involve? Firstly, patients undergo a camera examination (endoscopy) of their colon to conform that their UC is currently in remission. Then, having filled in questionnaires on their symptoms and disease activity, they are randomly allocated 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 a appendicectomy. After this stage, regardless of which group patients are in, the follow-up is the same. This involves regular reviews in the outpatient clinic, where the doctor and/or the research team discuss current symptoms and complete further questionnaires. These reviews take place around 6 weeks (appendicectomy group only), 3, 6, 9 and 12 months after entry to the trial. Any patient's medication can be changed or increased during the trial period if felt necessary by the medical team. All medication use is documented during the trial period, and notes made on any other effects of the disease patients suffer, such as time off work or days where patients are unable to function as they would like to. At the end of the trial, a further camera examination of the patient's bowel takes place. As part of the ACCURE-UK trial patients may also be asked to take part in a discussion (research interview) with a researcher from the ACCURE-UK team. These discussions help the team understand what it is like for patients to take part in the study, and help us to make sure that these perspectives influence the design of any follow on trial. What are the possible benefits and risks of participating? If allocated to the appendicectomy group and the operation does prove to have an impact on the disease activity in UC, there may be a potential benefit to an individual patient in taking part in terms of reducing the number or severity of disease flare-ups. This may in turn impact upon the future use of medication, number of hospital admissions and the need for major bowel surgery. If allocated to the control group, there is unlikely to be any personal benefit from taking part in the trial, although patients will undergo a period of careful disease medical treatment and monitoring. Some patients will draw satisfaction from the knowledge that their involvement, in either group, will help determine if this new proposed treatment has the potential to benefit all patients affected by UC. However it is important to note that like any surgery there is always the possibility of complications. We have done our best to reduce the chances of these by ensuring that only experienced and specialised colorectal consultant surgeons undertake operations during the trial. Where is the study run from? 1. Queen Elizabeth Hospital 2. Heartlands Hospital 3. Good Hope Hospital Sutton Coldfield 4. University Hospital of North Tees 5. Leicester General Hospital 6. St Mark's Hospital 7. Walsall Manor Hospital 8. University Hospital of Hartlepool When is the study starting and how long is it expected to run for? December 2014 to December 2016 Who is funding the study? NIHR Research for Patient Benefit (UK) Who is the main contact? Miss Rebecca Howard [email protected]

Critère d'inclusion

• Topic: Surgery, Gastroenterology; Subtopic: Surgery, Gastroenterology; Disease: All Surgery, All Gastroenterology

Liens

• ictrp
• isrctn