Preoperative exclusive enteral nutrition versus usual care in Crohn's disease

INTERVENTION: Patients will be randomised one of three arms for six weeks prior to surgery ‐ exclusive enteral nutrition or partial enteral nutrition with a Crohn's disease exclusion diet or usual care. Exclusive enteral nutrition provides 100% of a person nutritional requirements and excludes of all other foods and fluids with the exception of water and black tea or coffee. Exclusive enteral nutrition and partial enteral nutrition (50% of nutritional requirements) with a ready to drink polymeric nutrition formula (e.g. Ensure Plus or Fortisip) will be used for six weeks prior to surgery. Dietary education on how to use exclusive enteral nutrition or partial enteral nutrition with an exclusion diet will be delivered by a New Zealand Registered Dietitian using video consultation and phone follow up and with using existing education resources. The quantity of liquid nutrition drank by each participant will be calculated and monitored by the dietitian and individualised to each patient based on their weight and lifestyle using standard nutrition assessment tools. Adherence to the two enteral nutrition treatments will be monitored by patients counting the number of cartons of remaining each week and reporting this on an electronic form or to the dietitian during 4 telephone follow up calls during the six week treatment. Patients will also be asked to self‐report any deviations from enteral nutrition treatment protocols. CONDITION: Crohn's disease; ; Crohn's disease Oral and Gastrointestinal ‐ Crohn's disease Surgery ‐ Other surgery PRIMARY OUTCOME: To determine retention rate to the study intervention arms.; This will be assessed by calculating the number of patients enrolled in each arm of the study compared to the number who complete the intervention period. [20 months after enrolment of first participant.] To determine whether it is feasible to collect the planned primary and secondary effectiveness objectives. This will be assessed by calculating the proportion of patients who completed each outcome at each of the three time points. [20 months after enrolment of first participant] To determine whether it is feasible to recruit patients with Crohn’s disease undergoing gastrointestinal surgery in a single‐blinded RCT to compare enteral nutrition treatments and standard care. ; This will be assessed by calculating the recruitment rate (comparing the number of potentially eligible patients to the number of patients recruited) . [20 months after first participant enrolled] SECONDARY OUTCOME: Change in food‐related quality of life measured using validated FR‐QOL‐29 questionnaire.[Measured before and after the intervention and three months post surgery.] Disease activity measured using validated questionnaire the Harvey Bradshaw index[Baseline, pre‐surgery and three months post‐surgery.] Feasibility outcomes of adherence to enteral nutrition treatments. Measured using count number of supplement cartons and self‐reported consumption of disallowed foods and fluids. ; ; ; ; 30‐day post‐surgical complication rate using the Clavien Dindo classification.[30 days post‐surgery] Quality of life measured using the validated questionnaire UK‐IBDQ.[Baseline, pre‐surgery and three months post‐surgery] INCLUSION CRITERIA: Adults over 16 years old with diagnosed Crohn's disease who have consented to have elective gastrointestinal resection for the management of Crohn's disease. ; .[Four times during the six week intervention period at weeks 1, 2, 4 and 5.] Gut inflammation measured using biomarker faecal calprotectin.[Baseline, pre‐surgery and three months post‐surgery.] Hospital length of stay. Calculated from hospital records[Upon discharge from hospital after gastrointestinal surgery.] Intraoperative stoma formation[within 48 hours after surgery.] Mucosal damage before and after nutrition intervention. This will be measured by change in sMaRIA score calculated from a Magnetic Resonance enterography (MRE). [Calculated from a pre (within three months of enrolment in the study) and post intervention image (within the seven days prior to surgery date).] Nutritional status measured by assessing weight (measured in kilograms), mid‐arm muscle circumference (using tricep skin fold and mid arm circumference), handgrip strength (using a handgrip dynamometer), and body composition (using a bioelectrical impedance analyser).[Baseline, pre‐surgery and three month post‐surgery.] Primary effectiveness objective: