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

ABSTRACT Introduction This 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 analysis 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 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 -