Soop 2004.
Methods | Randomised clinical trial, Sweden/UK | |
Participants | 20 hospitalised adults undergoing elective major colorectal surgery, at nutritional risk due to major surgery Male:Female = 12:6 (gender not reported for two participants) Mean age = 62 years Exclusion criteria: age below 18 years or above 80 years; BMI below 18 or above 30 kg/m2 |
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Interventions | Experimental group: Immediate postoperative enteral nutrition with an energy‐dense residue‐free solution (1·5 kcal/ml Nutrison Energy, Nutricia)(n = 10) Control group: Immediate postoperative enteral nutrition with a hypocaloric solution with an indistinguishable appearance (0·2 kcal/ml Nutricia)(n = 10) | |
Outcomes | Urinary nitrogen losses, insulin resistance, blood glucose, complication and hospital stay | |
Study dates | Not stated | |
Notes | We contacted the authors in December 2015 by email: mattias.soop@mac.com. We received an initial reply but no further information was supplied. | |
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 | Low risk | The control group received a solution with an indistinguishable appearance. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no dropouts. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained and the trial did not report all‐cause mortality or serious adverse events. |
For‐profit bias | High risk | Financial support from Numico Research. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |