Beier‐Holgersen 1996.
Methods | Randomised double‐blind controlled trial No information provided about duration of study |
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Participants | 60 participants (30 in each group); mainly colorectal surgery (87%) Bowel resection Route of feeding: nasoduodenal Median age: 66.5 years (range 27‐93) (intervention group), 61.5 years (range 27‐80) (control group) Male:Female 18:12 (intervention group), 20:10 (control group) |
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Interventions | Intervention group: received a nutrition supplement of Nutridrink (orange flavour) within four hours postoperatively. Nutridrink contained 150 kcal/100 mL and 5 g protein/100 mL. Nutritional supplement given until fourth day. Control group: received placebo (water with orange flavour, no energy, vitamins or trace elements) during same period. |
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Outcomes | Wound infection, intraabdominal abscess, anastomotic leakage, mortality, postoperative complications (pneumonia, dehiscence, pulmonary failure), LoS, adverse events (nausea, vomiting). | |
Notes | Country of study: Denmark | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants (performance bias) All outcomes | Low risk | Reported as double‐blinded. Use of an identical placebo flavoured orange. Groups received different volume of drink (4000 mL vs. 4700 mL). Unlikely to unblind. |
Blinding of personnel (performance bias) All outcomes | Low risk | Reported as double‐blinded. Nutridrink or placebo in identical containers was administered by the nursing staff. |
Blinding of outcome assessor (detection bias) ‐ wound infections | Low risk | The principal investigator saw the patients every day during their stay in the ward, and all complications were recorded by the same investigator. The randomisation code was not broken until all results were available and all patients had been followed up for 30 days after surgery and all complications classified. |
Blinding of outcome assessor (detection bias) ‐ intraabdominal abscesses | Low risk | The principal investigator saw the patients every day during their stay in the ward, and all complications were recorded by the same investigator. The randomisation code was not broken until all results were available and all patients had been followed up for 30 days after surgery and all complications classified. |
Blinding of outcome assessor (detection bias) ‐ postoperative complications e.g. acute myocardial infarction, thrombosis or pneumonia | Low risk | The principal investigator saw the patients every day during their stay in the ward, and all complications (pneumonia, dehiscence, pulmonary failure, myocardial infarction) were recorded by the same investigator. The randomisation code was not broken until all results were available and all patients had been followed up for 30 days after surgery and all complications classified. |
Blinding of outcome assessor (detection bias) ‐ anastomotic leakage/dehiscence | Low risk | The principal investigator saw the patients every day during their stay in the ward, and all complications were recorded by the same investigator. The randomisation code was not broken until all results were available and all patients had been followed up for 30 days after surgery and all complications classified. |
Blinding of outcome assessor (detection bias) ‐ mortality | Low risk | The principal investigator saw the patients every day during their stay in the ward, and all complications were recorded by the same investigator. The randomisation code was not broken until all results were available and all patients had been followed up for 30 days after surgery and all complications classified. |
Blinding of outcome assessor (detection bias) ‐ adverse events (e.g. nausea, vomiting, abdominal distention, aspiration, tube blockage and any other adverse events | Low risk | (Nausea, vomiting) The principal investigator saw the patients every day during their stay in the ward, and all complications were recorded by the same investigator. The randomisation code was not broken until all results were available and all patients had been followed up for 30 days after surgery and all complications classified. |
Blinding of outcome assessor (detection bias) ‐ length of hospital stay | Low risk | The principal investigator saw the patients every day during their stay in the ward, and all complications were recorded by the same investigator. The randomisation code was not broken until all results were available and all patients had been followed up for 30 days after surgery and all complications classified. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 10% missing data. |
Selective reporting (reporting bias) | High risk | No protocol available. The outcome LoS was reported in results but not explicitly stated as an outcome of interest in methods (just PO course). |