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

Stein 2002.

Methods Randomised clinical trial, Germany
Participants 80 hospitalised adults admitted to intensive or intermediate care with percutaneous endoscopic gastrostomy, at nutritional risk due to being ICU patients
Male:Female = 33:47
 Mean age = 68 years
Exclusion criteria: chronically ill admitted only for PEG placement, outpatients, not eligible for ICU or intermediate care, undergoing Billroth operation, and a PEG placed for relief of gastric outlet obstruction, and ascites
Interventions Experimental group: received enteral feeding within 1 hr, with feeding that was provided through a tube by a continuous feeding pump and consisted of a polymeric iso‐osmolar formula 1 kcal/ml(n = 40)
Control group: no intervention for the first 24 hrs (n = 40)
Co‐interventions: All participants were tube‐fed 24 hrs after PEG placement. Both groups received feedings at a rate of 30 ml/hr for 20 hrs on day 1, 70 on day 2, and 100 on day 3 after initiation of feeding. Thereafter the volume was adjusted to the individual nutritional requirements as recommended by the nutrition team.
Outcomes Gastric residual volume, frequency of complications (stomatitis, vomiting, bleeding, leakage, diarrhoea, aspiration, and pneumoperitoneum), vital signs, abdominal distension, presence of bowel sounds, abdominal tenderness, and mortality
Study dates Not stated
Notes Note that all participants were tube‐fed after 24 hrs, and therefore the co‐intervention lasts longer than the intervention period alone. Results for maximum follow‐up are after 30 days. We contacted the author on 1st October 2015 by email: j.stein@em.uni‐frankfurt.de. We received no reply.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding was not performed.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Blinding was not performed.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There were complete outcome data for all participants.
Selective reporting (reporting bias) Unclear risk The trial reported all‐cause mortality but not serious adverse events. No protocol could be obtained.
For‐profit bias Unclear risk It was unclear how the trial was funded.
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias.