• Alexsander K Bressan, Derek J Roberts, Sana U Bhatti, Elijah Dixon, Francis R Sutherland, Oliver F Bathe, and Chad G Ball.
• Department of Surgery, University of Calgary and the Foothills Medical Centre, Calgary, Alberta, Canada.
• BMJ Open. 2015 Oct 7; 5 (10): e008948.

IntroductionAlthough randomised controlled trials have demonstrated that preoperative glucocorticoids may improve postoperative surrogate outcomes among patients undergoing major liver resection, evidence supporting improved patient-important outcomes is lacking. This superiority trial aims to evaluate the effect of administration of a bolus of the glucocorticoid methylprednisolone versus placebo during induction of anaesthesia on postoperative morbidity among adults undergoing elective major liver resection.Methods And AnalysisThis will be a randomised, dual-arm, parallel-group, superiority trial. All consecutive adults presenting to a large Canadian tertiary care hospital who consent to undergo major liver resection will be included. Patients aged <18 years and those currently receiving systemic corticosteroid therapy will be excluded. We will randomly allocate participants to a preoperative 500 mg intravenous bolus of methylprednisolone versus placebo. Surgical team members and outcome assessors will be blinded to treatment allocation status. The primary outcome measure will be postoperative complications. Secondary outcome measures will include mortality, the incidence of several specific postoperative complications, and blood levels of select proinflammatory cytokines, acute-phase proteins, and laboratory liver enzymes or function tests on postoperative days 0, 1, 2 and 5. The incidence of postoperative complications and mortality will be compared using Fisher's exact test, while the above laboratory measures will be compared using mixed-effects models with a subject-specific random intercept.Ethics And DisseminationThis trial will evaluate the protective effect of a single preoperative dose of methylprednisolone on the hazard of postoperative complications. A report releasing study results will be submitted for publication in an appropriate journal, approximately 3 months after finishing the data collection.Trial Registration NumberNCT01997658; Pre-results.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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