Early Enteral Nutrition After Paediatric Ostomy Closure ( <scp>EPOC</scp> ): A Protocol for a Multicentre, Prospective Randomised Controlled Trial

AIMS: This is the study protocol of an ongoing prospective randomised controlled trial (RCT) designed to assess the safety and efficacy of early enteral nutrition after elective enterostomy closure in children, written in accordance with the SPIRIT guidelines. MATERIALS AND METHODS: This is a multicentre, RCT that will be conducted in two Australian tertiary paediatric hospitals with a planned sample size of 68. Children that meet the inclusion criteria aged between 3 months and 16 years (inclusive) undergoing an elective enterostomy closure will be invited to participate. To assign treatment group, stratified permutated block randomisation will be used, with block sizes of four and six, and strata including: age group (3 months-< 6 years, 6-≤ 16 years); stoma type (ileostomy, colostomy); and hospital (Sydney Children's Hospital, Randwick, The Children's Hospital at Westmead). The control group will commence feeds on return of bowel function or when nasogastric tube aspirates are non-bilious. The intervention group will be offered feeds within 24 h of admission to the recovery room. The primary outcome is the length of stay, measured in hours. Secondary outcomes include time to oral feeds, time to first spontaneous passage of stool, highest post-operative pain score, complications, analgesia use and parent satisfaction. Data analyses will use an intention-to-treat principle. Length of stay, time to feeds and passing of stool will be analysed using restricted mean survival time. Other secondary outcomes will be analysed using regression models.