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. 2017 May 19;2017(5):CD011598. doi: 10.1002/14651858.CD011598.pub2

Barlow 2011.

Methods Randomised clinical trial, hospital in UK
Participants 121 hospitalised adults; most suspected upper gastrointestinal malignancy referred for major elective surgery, at nutritional risk due to major surgery
Male:Female = 83:38
Mean age = 64 years
Exclusion criteria: age under 18 years; unable or unwilling to give informed consent; pregnant; pre‐operative infection; previous intestinal surgery resulting in residual small intestine length of less than 100 cm
Interventions Experimental group: Early Enteral Nutrition was delivered via a needle catheter jejunostomy.
Nutritional support begun within 12 hrs of the surgery at 20 ml/hr of a standard 1 kcal/ml commercial whole protein enteral feed for the first 24 hrs in participants undergoing oesophagogastric resection, with the rate increasing as tolerated by 10 ml/hr every 12 hrs, until the maximum feed target rate of 80 ml/h was achieved.
Participants undergoing pancreatic resection were started on 10 ml/hr of a 1.3 kcal/ml commercial semi‐elemental enteral feed on the first post‐operative day, which was then steadily increased as for the oesophagogastric participants. The aim was to achieve a minimum of half of nutritional requirements by the 5th postoperative day.
 Intravenous fluids were administered in addition to the enteral feeding as necessary to maintain fluid balance. Once oral intake was established, participants began a 1.5 kcal/ml enteral feed and converted to overnight enteral nutrition via the jejunostomy over 12 hrs. This continued until it was deemed that 75% of nutritional requirements were being achieved orally. (n = 64)
 Control group: Participants were kept nil by mouth, with hydration maintained by means of intravenous fluids, which continued until the introduction of oral fluids and diet. These participants also received 10 ml/hr of sterile water via a needle catheter jejunostomy until introduction of oral fluids. (n = 57)
Outcomes Postoperative morbidity and mortality, wound infections, chest infections, anastomotic leaks, length of hospital stay
Study dates  
Notes We contacted the authors on 30th June 2015 by email: barlowR1@cf.ac.uk. We received no reply.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The randomisation sequence was generated by computer in permuted blocks of 30.
Allocation concealment (selection bias) Low risk The code was kept in opaque, sealed envelopes labelled with sequential study numbers in a locked box.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk The trial is described as unblinded.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk The trial is described as unblinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts and data on all participants
Selective reporting (reporting bias) Low risk Protocol is available, but contains no outcomes. In the trial all‐cause mortality and serious adverse events are reported.
For‐profit bias Low risk This trial was funded by a grant from The Health Foundation, London, UK.
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias.