Zareba 2013b.
Methods | Randomised clinical trial, Poland | |
Participants | 75 hospitalised adults undergoing elective gastric and large intestine cancer surgery, at nutritional risk due to major surgery Male:Female = 38:37 Mean age = 66 years Exclusion: frank diabetes; preoperatively‐diagnosed resistance to insulin; stomach emptying disorders, undernourishment (according to SGA and NRS 2002) |
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Interventions | Experimental group: Group III: 25 participants who received standard hospital diet and TPN (with the same ingredients and energy value as in group II), as well as prior to the surgery; oral preoperative preparation. The evening before the surgery, the participants were given 800 ml of the preparation and 400 ml again on the actual day of the surgery (but no later than 2 hours prior to the start of surgery) (n = 25) Control group: Received no preparations influencing the perioperative insulin resistance level (n = 25) Co‐intervention: They had standard hospital meals for 4 days prior to the surgery. |
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Outcomes | Insulin resistance level | |
Study dates | "Between 2008‐2009" | |
Notes | Same trial as Zareba 2013a but with group I vs III. We contacted the authors on 25th September 2015 by email: nikt00@gazeta.pl. 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 | Trial was not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Trial was not blinded. |
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 all‐cause mortality or 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. |