Foschi 1986

Methods	Randomised trial comparing artificial nutrition (most receiving enteral nutrition) to no artificial nutrition in patients hospitalized for surgery for obstructive jaundice. Geographical location Milan, Italy. Study published 1986.
Participants	Inclusion criteria: Patients with obstructive jaundice with bilirubin > 200 micromol/l who were eligible for surgery with preoperative transhepatic biliary drainage. Exclusion criteria: None cited. 60 patients (39 men/21 women, mean age 64) described, but there were 4 other dropouts.
Interventions	Intervention group received preoperative enteral nutrition through nasogastric tube (commercial formulation [Precision BR] with 10% peptides, 0.8% lipid, 81.9% carbohydrate); some patients received parenteral nutrition (50% dextrose and 8.5% AA [Freamine III]); a "few" enteral nutrition recipients received amino acids through nasogastric tube volume was 2‐3 liters/day. Controls received standard diet. Duration at least 12 days (mean 20 days). All patients received biliary decompression preoperatively.
Outcomes	Mortality, infections, postoperative total/intra‐abdominal/pneumonia/wound complications. Body weight and triceps skinfold thickness noted not to be different, but no numerical data.
Category of study	Enteral nutrition/surgery.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full paper.
Notes	E‐mail request for more information sent to Dr Foschi on September 17, 2011 (Diego.Foschi@unimi.it). 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 "randomly divided".
Allocation concealment (selection bias)	Unclear risk	No details.
Blinding (performance bias and detection bias) All outcomes	High risk	Not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Four dropouts accounted for.
Selective reporting (reporting bias)	Low risk	Molrtality and morbidity outcomes reported.
Other bias	Unclear risk	Funding source not identified.
Intent to treat analysis	High risk	Could not be done.
Baseline imbalance?	Low risk	No difference in per protocol group of 60 patients.
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.