Extrait

Background and study aims Crohn’s disease affects any part of the digestive system, most commonly the last part of the small intestine. It usually results in narrowing of the bowel at this point which can prevent food passing through normally. This can lead to abdominal pain, bloating and even vomiting. Whilst Crohn’s disease is normally managed with medication, many patients require an operation to remove the affected portion of the bowel. During the operation the affected segment of bowel is removed and the ends of the remaining bowel are joined back together (an anastomosis). Following this, up to 60% of patients develop recurrent symptoms and up to 50% require a further operation. Recurrence of Crohn’s disease at the site of the anastomosis can be detected as early as 6 months following surgery. This study is hoping to demonstrate that removing an additional length of small bowel may result in a lower risk of recurrence at the anastomosis, thereby decreasing the need for further surgery in the future. Who can participate? Anyone aged 16 or over who is undergoing an operation for Crohn’s disease affecting the last part of the small bowel is potentially eligible to enter the study. What does the study involve? When patients with Crohn’s disease undergo an operation to remove a length of bowel, the bowel is normally divided close (about 2 cm) to the abnormal segment. This is done in the hope of preserving the total length of bowel should future operations become necessary. Sometimes, there is inflammation at these cut ends and this has been associated with an increased risk of recurrence at the anastomosis. Patients who agree to enter the study will be randomly selected to have either an additional 8 cm of bowel removed (extended resection) or have no additional bowel removed (standard resection). At about 6 months after their operation they will undergo colonoscopy. This is to allow us to see the anastomosis visually and take samples from it to see if there are any early signs of disease recurrence. What are the potential risks or benefits of participating in the trial? Whilst there may be no immediate benefit to taking part in this study, participation will allow us to find out whether there is any potential benefit to patients with Crohn’s disease undergoing an extended resection. This may benefit patients in the future if there is a clear reduction in the rate of disease recurrence at the site of the surgery. Patients in the study are subjected to exactly the same risks as patients who choose not to participate in the study. These risks are inherent to any operation on the intestines. The risks of the operation will be explained in full at the time of obtaining consent for your operation. Where is the study run from? The study is being run from The Churchill Hospital, which is part of Oxford University Hospitals NHS Trust, UK. When is the study starting and how long is it expected to run for? The study started in July 2013 and is expected to be completed in six years. Who is the main contact? Mr Richard Lovegrove, [email protected] Mr Bruce George, [email protected]

Critère d'inclusion

• Crohn’s Disease

Liens

• ictrp
• isrctn