Pupelis 2001.
Methods | Randomised clinical trial, Latvia | |
Participants | 60 hospitalised adults undergoing surgery for peritonitis and severe pancreatitis. None of the included participants received TPN before surgery. At nutritional risk due to major surgery Male:Female = 45:15 Mean age = 51.4 years Exclusion criteria: none specified |
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Interventions | Experimental group: Jejunal feeding was started during the 1st 12 hrs postoperatively in the ICU with full‐strength whole‐protein formula (1 kcal/mL) or oligopeptide‐based formula (1 kcal/mL), providing at least 300 mL each day.(n = 30) Control group: Standard intravenous fluids(n = 30) |
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Outcomes | Complications, SIRS, death caused by multiple organ dysfunction syndrome, mortality | |
Study dates | January 1997 to April 1999 | |
Notes | We contacted the authors on 23rd June 2015 by email: pupelis@gailes.lv. We received no reply. | |
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 | Only the experimental group received a tube. |
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) | Low risk | No protocol was found. Serious adverse events and all‐cause mortality were reported. |
For‐profit bias | High risk | The trial was funded by Amaija ltd. (Nutrition manufacturer). |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |