Fasth 1987.
Methods | Randomised clinical trial, Sweden | |
Participants | 92 hospitalised adults undergoing major colorectal surgery for carcinoma of the large bowel or inflammatory bowel disease Male:Female = unknown Mean age = unknown Exclusion criteria: none specified |
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Interventions | Experimental group: 48 participants were allocated to postoperative TPN for a minimum of 7 days or until an oral diet was tolerated. The TPN was given through a central venous catheter and included infusion of an amino acid solution to a mean nitrogen intake of 215+8 mg/ kg/ day, and 500 ml of a 20% fat emulsion plus 10% dextrose to 45 + 1.6 kcal/ kg/day. The TPN was given for 9.7 + 1.1 days. 20 mmol of phosphate was added daily to everyone in the TPN group. (n = 48)
Control group: No intervention (n = 44) Co‐interventions:10% dextrose solution containing electrolytes according to individual needs until an oral diet was tolerated, these participants were given an IV fusion with a mean of 16 + 0.8 kcal/kg/day for 6.2 + 0.7 days (mean + SD). |
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Outcomes | Overall mortality, serious adverse events (septic and non‐septic complications), morbidity | |
Study dates | Not described | |
Notes | We could obtain no contact information for the authors. | |
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 | Unclear risk | Not described |
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 described. |
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 | The trial was funded by Vitrum AB. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |