Müller 1982b.
Methods | Randomised cclinical trial, Germany | |
Participants | 160 hospitalised adults with carcinoma of the oesophagus, stomach, colon, rectum or pancreas, at nutritional risk due to major surgery of gastrointestinal carcinoma Male:Female = 77:48 (gender not reported for 35 participants) Mean age = 59 years Exclusion criteria: Total obstructions of the gut |
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Interventions | Experimental group: Preoperativ parenteral nutrition: The experimental group received 10 days of preoperative parenteral nutrition group (1.5 g amino acids/kg body weight; 45 kcal/kg body weight with half derived from lipids; electrolytes, trace elements, and vitamins) by a central venous catheter(n =55) Control group: Treatment as usual. They received regular hospital diet of 2400 kcal/day. (n = 40) |
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Outcomes | ||
Study dates | ||
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random‐numbers table |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not possible due to the nature of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | 33 (13%) of participants were withdrawn from the trial and analysis and reasons for withdrawal were clearly stated. |
Selective reporting (reporting bias) | Low risk | No protocol could be obtained, but the trial reported mortality and serious adverse events. |
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. |