Optimisation before Crohn's surgery using Exclusive enteral Nutrition (OCEaN): A randomised controlled trial to determine whether preoperative exclusive enteral nutrition is more clinically and cost effective compared with standard care in patients u

BACKGROUND: Exclusive enteral nutrition (EEN) is commonly used in paediatric Crohn's disease patients as a first-line therapy for inducing remission. Despite advances in immunosuppressive and biologic treatments, 23%-47% of patients with Crohn's disease will require surgery, with approximately 22% needing repeat surgeries. Potential suggested benefits of EEN in the perioperative setting include reduced steroid usage, reduced operative complications, and reduced need for stoma formation. METHODS: A multi-centre, two-arm, parallel group, open-label, pragmatic randomised controlled trial to assess the clinical and cost-effectiveness of preoperative EEN. The trial will be conducted in at least 40 UK-wide tertiary and district general NHS hospitals. Participants will be randomised to either six weeks of preoperative EEN or standard care as per local standard care. Primary outcomes will be quality of life and post-surgical complications at six weeks and 30 days post-surgery, respectively. DISCUSSION: The optimisation before Crohn's surgery using exclusive enteral nutrition trial aimed to determine whether preoperative EEN is more clinically and cost effective compared with standard care in patients undergoing surgery for Crohn's disease. TRIAL REGISTRATION: ISRCTN73953171.