Optimisation before Crohn’s surgery using Exclusive enteral Nutrition (OCEaN study)

To determine the impact of pre-operative Exclusive Enteral Nutrition (EEN) in patients undergoing surgery for Crohn’s Disease (CD). The primary objective is to evaluate whether 6 weeks of pre-operative EEN (a) reduces the risk of complications and/or (b) improves patient reported outcomes 6 weeks post CD surgery. Secondary objectives: to determine the effect of the intervention on a range of clinical, endoscopic and patient reported outcomes up to 12 months post-operatively and to determine the Cost-Effectiveness of the intervention. Studies on the role of EEN in the pre-operative optimisation for CD surgery in adults suggest that EEN may avoid the need for steroids, reduce post-operative complications, reduce the need for stoma, reduce length of hospital stay and improve pre-operative parameters such as body mass index whilst reducing inflammatory markers such as c-reactive protein. However, these studies are retrospective and were not powered to demonstrate significance. No studies have looked at quality of life or patient reported outcomes with or without EEN in CD surgery. European Crohn’s and Colitis Organisation (ECCO) and European Society of Coloproctology joint statement recommends optimisation of nutrition preoperatively. However, they acknowledge there is not enough evidence to recommend routine use of EEN in adults. The 2020 ECCO review of IBD perioperative dietary therapy recognises that EEN shows promise as a preoperative optimisation strategy but do not recommend routine use due to lack of high-quality evidence. This prospective multicentre randomised study aims to define the role of EEN in the pre-operative management of CD. This will be a Multi-centre, Two arm, Parallel group, Open label, Pragmatic Randomised Controlled Trial, with an internal pilot and economic evaluation. 618 adult patients (>=16 years) undergoing planned surgery for small bowel and/or colonic CD will be randomised 1:1 to either six weeks of EEN prior to surgery or usual diet as per the local practice. Patients will be recruited in secondary care (tertiary referral centres and District General Hospitals) across the UK. The study has dual primary outcomes which will be measured at six weeks post operation – the Crohn’s Life Impact Questionnaire is a CD patient-reported outcome assessing quality of life, and the Comprehensive Complication Index, which is a measure of post-operative complications. Secondary outcomes include length of hospital stay, length of bowel resected, number of anastomoses, need for ileostomy, leak rate, frequency of re-operation, clinical recurrence, patient adherence and acceptability of EEN and cost effectiveness. The internal pilot will aim to recruit 100 patients from 20 sites over 9 months. Stop/Go criteria to full trial include recruitment rate, acceptance of and compliance with EEN and delays to operation. The anticipated start date is February 2023. The project duration is 54 months. This includes a set-up phase of 6 months, recruitment of 29 months (including 9 month pilot), follow up of 13 months (includes 1 month for lag from randomisation to surgery), and 6 months for final data analysis and write up. Findings will be disseminated with the help of our patient panel, social media as well as Crohn’s & Colitis UK. We will present at national and international conferences and publish in open access journal. We will develop run webinars and family days to ensure findings are widely disseminated.