Sharma 2013.
Methods | Randomised clinical trial, UK | |
Participants | 55 hospitalised adults undergoing colorectal surgery, at nutritional risk due to major gastro‐intestinal surgery Male:Female = 35:20 Mean age = 66 Exclusion criteria: Dementia, lactose intolerance, pregnancy, diabetes mellitus, age under 16, musculoskeletal conditions preventing accurate use of the hand‐grip dynamometer and unable to feed orally preoperatively. Postoperative exclusion criteria were postoperative admission to ICU or administration of TPN. |
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Interventions | Experimental group: Received standard diet + 6 x 60 ml/day of Pro‐Cal (3.33 kcal/ml and 0.06 mg/ml of protein) for the duration of the hospital stay(n = 32) Control group: Received standard diet for the duration of the hospital stay (n = 30) | |
Outcomes | Primary outcome: Muscle strength at discharge Secondary outcome: Daily calorie intake, nausea, days to first flatus, days to first bowel movement and postoperative length of hospital stay |
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Study dates | Between June 2007 and November 2010 | |
Notes | We contacted the authors in September 2015 by email: dr_miteshsharma@yahoo.co.uk. We received no reply. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Unclear risk | The envelopes were described as sealed but not opaque. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | 7 randomised participants were later excluded resulting in above 5% dropouts. The trial did not account for the missing 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 resources of our department were utilized to conduct the study". |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |