MEsenteric Excision and Kono-S Anastomosis Trial (MEErKAT)
Crohn’s disease
The trial follows the standard pathway for ileocaecal Crohn’s. Participants are recruited when surgery is deemed appropriate. Potential participants will be discussed at MDT meetings and identified at the time of pre-operative assessment before the day of surgery. Surgeons, research nurses and trainees will also check waiting lists for those listed for ileocaecal resection for primary or recurrent Crohn’s disease. If a patient is interested in taking part, the local research team will review information about their Crohn’s disease from their medical records. A member of the patient's care team will identify and consent eligible participants. Potential participants will receive an approved Participant Information Sheet (PIS) and be given the opportunity to ask questions from both the surgical and research team. Potential participants will be approached either at their clinic visit prior to surgery or pre-operative assessment. At a pre-operative assessment or on the day of surgery, the surgeon, research nurse or trainee will offer entry into the trial and consent will be obtained. No study-related procedures will occur before the approved consent form is signed, other than the initial case note review for eligibility. A screening log will be maintained for each hospital site, to document all potential participants screened, whether they were recruited, and any reasons for non-recruitment where this information is available. Screening logs will be requested and reviewed by CTRU on a regular basis. Baseline Visit If a patient is happy to proceed, and their surgeon feels the trial is appropriate for them, they will be asked to sign a consent form to join the trial. Following consent, they will then complete separate questionnaires about how they feel (physically and mentally) and about their Crohn’s disease. These are called the IBD-Control, CDAI and EQ-5D questionnaires. These are to help researchers understand a patient's health at the start of the trial and will as
People aged over 18 years undergoing ileocaecal resection for primary/recurrent Crohn’s disease where an anastomosis is carried out
Participant exclusion criteria as of 10/11/2023: 1. Patients with markedly extensive inflammation affecting the vascular root of the mesentery seen on imaging or at operation 2. Patients undergoing stoma formation proximal to the anastomosis 3. Patients who have a contraindication to subsequent colonoscopy 4. Patients unable to give full informed consent 5. Patients who are pregnant (as ascertained by standard pregnancy tests undertaken at preoperative visits as per standard clinical care) 6. Patients who, in the opinion of the principal investigator, do not meet the criteria for relevant surgery Previous participant exclusion criteria: 1. Patients with markedly extensive inflammation affecting the vascular root of the mesentery seen on imaging or at operation 2. Patients undergoing stoma formation 3. Patients who have a contraindication to subsequent colonoscopy 4. Patients unable to give full informed consent 5. Patients who are pregnant (as ascertained by standard pregnancy tests undertaken at preoperative visits as per standard clinical care) 6. Patients who, in the opinion of the principal investigator, do not meet the criteria for relevant surgery