Early v. postponed supplementary parenteral nutrition after major emergency abdominal surgery (The EATERS trial): protocol and statistical analysis plan

Parenteral nutrition (PN) is used when sufficient oral or enteral nutrition is not possible or feasible. Current guidelines provide limited practical guidance in emergency surgical patients, and the evidence is sparse. The EATERS trial aims to investigate the effect of early supplemental PN on postoperative infections in major emergency abdominal surgery patients. The EATERS trial is an investigator-initiated, multicentre, randomised controlled trial. The trial will include 342 adults with reduced oral intake after emergency abdominal surgery, randomising them in a 1:1 ratio to early or postponed supplemental PN. The intervention group (early) will receive supplemental PN starting on postoperative day (POD) 2 for up to five days. The control group (postponed) will receive standard care and, if oral intake remains insufficient, will begin supplemental PN on POD5 for up to five days. The primary outcome is the incidence of postoperative nosocomial infections during admission. Outcome assessors and the statistician will be blinded to the treatment allocation. The secondary outcomes include non-infectious complications during admission, length of stay, mortality risk at 30 and 90 d, energy and protein intake, serious adverse events and readmission risk within 30 and 90 d of surgery. Analyses will follow the intention-to-treat principle and logistic regression used for primary outcome analysis. The EATERS trial will provide novel insights into the timing of PN in a high-risk patient population. This protocol and statistical analysis plan will reduce bias and increase transparency in the conduct and analysis of the trial.