Wu 2007a.
Methods | Randomised clinical trial, China | |
Participants | 646 hospitalised adults with gastrointestinal cancer, at nutritional risk due to gastro‐colorectal surgery Male:Female = 366:280 Mean age = 62 years Exclusion criteria: severe liver function damage (Child.Pugh class > B), severe impairment of renal function (serum creatinine > 265.2 mol/L or needed haemodialysis), severe respiratory dysfunction (arterial PaO2 < 70 mmHg), severe impairment of cardiac function (NYHA class > 3), already infected, (temperature > 37.6 °, WBC > 11.0 x 109/L or bacteraemia), immune deficiency or damage (after radiotherapy or chemotherapy or WBC < 2.0 × 109/L) |
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Interventions | Experimental group: Group 1: enteral nutrition of 125.5 kJ (30 cal)/(kg/day), 0.25 g/(kg/day) nitrogen. The course of the treatment was 7 days. (n = 215) Group 2: parenteral nutrition of 125.5 kJ (30 cal)/(kg/day), 0.25 g/(kg/day) nitrogen, electrolyte, microelements and vitamins. The course of the treatment was 7 days. (n = 215) Control group: Conventional fluid infusion (5% and 10% glucose and electrolytes) until they resumed normal eating ( 43.9 ˜ 13.4) kJ (10.5 ˜ 3.2) kcal/(kg/day). The course of the treatment was unclear. (n = 216) |
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Outcomes | Triceps folds, forearm midpoint circumference, body weight, albumin, transferrin, blood biochemistry, liver function and the calculation of nitrogen balance. Postoperative complications, mortality, serious adverse events, morbidity, postoperative length of hospital stay and weight change | |
Study dates | Not stated | |
Notes | Same as Wu 2007b, but with group 1 vs control. We found no contact information for the authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The sequence generation was achieved using computer random‐number generator. |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The number of participants with incomplete data was not reported. |
Selective reporting (reporting bias) | Unclear risk | 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. |