Methods |
Randomised trial comparing preoperative branched‐chain amino acid‐enriched supplements to usual diet in patients subsequently undergoing partial hepatectomy for the resection of benign or malignant tumours. |
Participants |
Patients with benign or malignant tumours. |
Interventions |
Intervention group received a commercial supplement (Aminoleban EN) twice daily for two weeks preoperatively and for 1 to 7 days postoperatively; the control group only consumed normal diet. |
Outcomes |
Mortality, duration of operation/hospitalization, intraoperative blood loss, postoperative complications including "clinical and biologic signs of hepatic dysfunction". |
Category of study |
Supplements/Surgical. |
Sample size calculation |
None reported if done. |
Full paper or abstract only |
Full paper. |
Notes |
14 patients excluded form analysis because of reasons that became apparent at the time of surgery; since the trial began 2 weeks earlier, these had to be excluded after randomisation (although that fact was not explicitly stated in the paper). Trial presented at Digestive Disease Week 2009 where additional information was available. Request for further information sent to Drs Ishikawa and Tajiri via e‐mail (martinishikawa@nms.ac.jp and tajirit@nms.ac.jp) on September 19, 2011. 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 |
Patients "randomly assigned", but no further details. |
Allocation concealment (selection bias) |
Unclear risk |
At time of presentation of paper at national meeting, stated that sealed envelopes employed, but unclear if opaque and serially numbered. |
Blinding (performance bias and detection bias) All outcomes |
High risk |
No placebo solution employed. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Reasons for exclusion stated, but large number of dropouts (14 of original 38). |
Selective reporting (reporting bias) |
High risk |
Explicitly stated in Methods section that lengths of stay data would be collected, but this outcome was not reported quantitatively or qualitatively. |
Other bias |
Unclear risk |
Funder not reported. |
Intent to treat analysis |
High risk |
14 participants unaccounted for. |
Baseline imbalance? |
Low risk |
There were no differences in the remaining 24 patients with regard to baseline features. |
Early stopping? |
Unclear risk |
No sample size calculation reported and there was no explanation as to why the trial was stopped when it was. |