Iresjö 2008.
Methods | Randomised clinical trial, Sweden | |
Participants | 12 hospitalised adults undergoing surgery of the upper gastrointestinal tract, at nutritional risk due to major surgery Male:Female = 7:5 Mean age = 64 years Exclusion criteria: diabetes or steroid medications |
|
Interventions | Experimental group: Parenteral nutrition: TPN was supplied as an all‐in‐one bag (0.16 gN · kg−1 of body weight · day−1 (30 kcal · kg−1 of body weight · day−1); Kabiven® Perifer; Fresenius Kabi(n = 6) Control group: Placebo (saline)(n = 6) Infusions started between 16.00 and 17.00 hours on the day before the operation, and continued at a constant rate until muscle biopsies were taken from the rectus abdominis muscles directly after the induction of anaesthesia (15 – 16 hrs later) |
|
Outcomes | Levels of amino acids and substrates in peripheral blood, formation of 4E‐BPI‐eIF4E and eIF4G‐eIF4E complexes, 4E‐BPI phosphorylation, p70S6K phosphorylation | |
Study dates | Not stated | |
Notes | We contacted authors about risk of bias details on 6th September 2015 by email: kent.lundholm@surgery.gu.se. We received additional information on randomisation sequence, blinding and incomplete outcome data. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was done after the participant was recruited to the study by the responsible physician. Randomisation was done by a computer algorithm based on age, sex, cancer (type of cancer)/no cancer, height, weight, % weight loss (compared to pre‐disease weight). |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded as the control group received placebo. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding of outcome assessment was not performed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no dropouts and complete data for all 12 participants. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained and the trial did not report on all‐cause mortality or serious adverse events. |
For‐profit bias | Low risk | The study was, in part, supported by grants from the Swedish Cancer Society (2014), the Swedish Research Council (08712), Tore Nilson Foundation, Assar Gabrielsson Foundation (AB Volvo), Jubileumskliniken foundation, IngaBritt & Arne Lundberg Research Foundation, Swedish and Göteborg Medical Societies, the Medical Faculty, Göteborg University, VGR 19/00, 1019/00, Swedish Nutrition Foundation. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |