Tong 2006a.
Methods | Randomised clinical trial, China | |
Participants | 126 hospitalised adults with gastrointestinal tumour, at nutritional risk due to major surgery Male:Female = 62:46 Mean age = 68.2 years Exclusion criteria: Body weight over or less than 15% of the participants usual body weight, diabetes and decompensate hyperthyroidism or serious hepatorenal dysfunction (ALT > 60 U/L, TBiL > 25.7 μmol/L, BUN 10.7 mmol/L, Cre > 132.9 μmol/L) and haemorrhagic shock |
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Interventions | Experimental group 1: TPN after surgery (50 ml/kg/day, N/Q = 1 g:552 kJ) for intravenous drip (n = 45) Experimental group 2: Enteral nutrient fluids (50 ml/kg/day, N/Q = 1 g : 552 kJ) for infusion after gastrointestinal fistulation, 500 ml (40 ‐ 50 ml/hr) of the fluids after 1st 24 hrs, 1000 ml (80 ‐ 120 ml/hr) after 48 hrs, and 1500 ml (80 ‐ 120 ml/hr) after 72 hrs. Semi‐liquid diet after 6 ‐ 7 days of infusion. (n = 45) Control group: Conventional therapy of fluid infusion, transition diet after recovery of intestinal peristalsis (n = 36) |
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Outcomes | Complications, body weight (9 days after treatment) | |
Study dates | Not stated | |
Notes | Same as Tong 2006b, but with experimental group 1 vs. control group. We tried but failed to contact the authors on 23rd September 2015 by phone and email: surgerytong@yahoo.com.cn. | |
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 | 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 and the trial did not report on all‐cause mortality or serious adverse event. |
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. |