Mikagi 2011

Methods	Randomised trial comparing use of preoperative supplements to standard care. Geographical location Japan. Paper published in 2011.
Participants	Inclusion criteria: Patients undergoing segmentectomy or more extensive hepatectomy not including biliary tract reconstruction for liver tumors (HCC, cholangiocellular carcinoma, metastatic liver cancer, carcinoid) between 2/05 and 12/08 Exclusion criteria: Marked renal dysfunction (creatinine clear < 30 ml/min), severe diabetes (requiring insulin), chemoradiotherapy within past month, inability to take oral nutrition.
Interventions	Intervention group received 750 cc/day commercial supplement (Impact®, Ajinomoto Pharm, Tokyo) + 1/2 daily diet. Control group received regular diet.
Outcomes	Primary outcomes appeared to be surrogate measures of inflammatory status (WBC count, interleukin 6 levels), "nutrition" (albumin, prealbumin), liver "function" (ALT, AST levels), and fatty acid metabolism (eicosopentaenoic acid level). Other outcomes reported included postoperative complications (including infections), duration of stay.
Category of study	Supplements/Surgical.
Sample size calculation	Not reported.
Full paper or abstract only	Full paper.
Notes	Concern about randomisation ‐ see comment below. E‐mail sent requesting further information about trial sent to Dr Mikagi on 2/17/12 at mikagi@med.kurume‐u.ac.jp. No response has been received as of March 20, 2012.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only states that patients were randomised. However, according to the patient flow sheet, 41 patients were initially randomised, 26 to the supplement arm and 15 to the controls, and there were 15 dropouts (12 from the supplement arm).
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding (performance bias and detection bias) All outcomes	High risk	Not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Since reasons for all dropouts were provided (12 dropouts from supplement arm [8 change of treatment, 3 side effects, 1 withdrew consent], 3 from control arm [2 change of treatment, 1 withdrew consent], our criteria for low risk met. However, the disproportionate number from supplement, especially for change in treatment or side effects, could have introduced bias.
Selective reporting (reporting bias)	High risk	No mortality data reported.
Other bias	Unclear risk	Unclear funder.
Intent to treat analysis	High risk	15/41 patients dropped out and no intent‐to‐treat analysis reported.
Baseline imbalance?	Low risk	No baseline differences in the per protocol groups.
Early stopping?	Unclear risk	No sample size provided and not clear why trial was stopped when it was.