title: Preoperative single-dose methylprednisolone versus placebo after major liver resection in adults: protocol for a randomised controlled trial.
abstract: BACKGROUND
  Although 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
  This 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.
  
  
  BACKGROUND
  This 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.
  
  
  BACKGROUND
  NCT01997658; Pre-results.
authors.affiliation: Department of Surgery, University of Calgary and the Foothills Medical Centre, Calgary, Alberta, Canada.
authors.forename: Alexsander K
authors.initials: AK
authors.lastname: Bressan
authors.affiliation: Department of Surgery, University of Calgary and the Foothills Medical Centre, Calgary, Alberta, Canada Division of Epidemiology, Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Derek J
authors.initials: DJ
authors.lastname: Roberts
authors.affiliation: Department of Surgery, University of Calgary and the Foothills Medical Centre, Calgary, Alberta, Canada.
authors.forename: Sana U
authors.initials: SU
authors.lastname: Bhatti
authors.affiliation: Department of Surgery, University of Calgary and the Foothills Medical Centre, Calgary, Alberta, Canada.
authors.forename: Elijah
authors.initials: E
authors.lastname: Dixon
authors.affiliation: Department of Surgery, University of Calgary and the Foothills Medical Centre, Calgary, Alberta, Canada.
authors.forename: Francis R
authors.initials: FR
authors.lastname: Sutherland
authors.affiliation: Department of Surgery, University of Calgary and the Foothills Medical Centre, Calgary, Alberta, Canada.
authors.forename: Oliver F
authors.initials: OF
authors.lastname: Bathe
authors.affiliation: Department of Surgery, University of Calgary and the Foothills Medical Centre, Calgary, Alberta, Canada.
authors.forename: Chad G
authors.initials: CG
authors.lastname: Ball
mesh_terms: D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D004305:Dose-Response Relationship, Drug; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006498:Hepatectomy / Q000009:adverse effects*; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D011183:Postoperative Complications / Q000517:prevention & control*; D011300:Preoperative Care / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D008775:Methylprednisolone
keywords: Liver resection; acute-phase response; hepatectomy; methylprednisolone; preoperative glucocorticoid; randomized controlled trial