Early enteral nutrition after Paediatric Ostomy Closure (EPOC): a protocol for a multicentre, prospective randomised controlled trial

IntroductionThis is the study protocol of an ongoing prospective randomised controlled trial (RCT) written as per the SPIRIT guidelines. This RCT is designed to assess the safety and efficacy of early enteral nutrition after elective enterostomy closure in paediatric patients. Methods and analysisThis 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 three 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 size of four and six, and strata including: age group (3 months - <6 years, 6 - [&le;]16 years); stoma type (ileostomy, colostomy); and hospital (Sydney Childrens Hospital, Randwick, The Childrens 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 hours 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. Ethics and disseminationThe Sydney Childrens Hospital Network Human Research Ethics Committee approved the research (2021/ETH01062). The aim is to report the results in peer- reviewed journals, seminars and conference presentations. Trial registrationACTRN12621001414808; Australian New Zealand Clinical Trials Registry. STRENGTHS AND LIMITATIONS OF THIS STUDYO_ST_ABSStrengthsC_ST_ABSO_LIThis is a stratified, well-powered prospective, randomised controlled trial that minimises heterogeneity between cases with strict eligibility criteria. C_LIO_LIResults will be analysed according to the intention-to-treat principle, utilising statistical methods to fully account for the spectrum of missingness. C_LIO_LIThis study includes two separate tertiary paediatric hospitals in Australia, increasing external validity. C_LI LimitationsO_LIDue to the nature of the intervention (timing of feeding), it is not possible to blind participants and researchers to the study group. C_LIO_LISome outcomes require parent self-reporting, introducing potential bias. C_LI