Dag 2011.
Methods | Randomised controlled trial Study conducted August 2007 to September 2009 |
|
Participants | 199 participants: intervention (n = 99), control (n = 100) Elective open colorectal surgery Route of feeding: oral Mean age (range): 62 years (35‐85) (intervention group), 61 years (17‐89) (control group) Sex (M:F) 52:47 (intervention group), 61:39 (control group) |
|
Interventions | Intervention group: oral feeding commenced approximately 12 hours after operation with a fluid diet; this was gradually increased to a solid diet as tolerated by the patient. Control group: fasted until passage of flatus or stool. |
|
Outcomes | Wound infection, anastomotic leakage, pneumonia, mortality, LoS. | |
Notes | Country of study: Turkey | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed according to a computer generated list immediately after surgery by an independent computer consultant. |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants (performance bias) All outcomes | High risk | No reports of attempts to blind participants. Participants are unlikely to be adequately blinded with an intervention of this nature. |
Blinding of personnel (performance bias) All outcomes | High risk | No reports of attempts to blind personnel. Personnel are unlikely to be adequately blinded with an intervention of this nature. |
Blinding of outcome assessor (detection bias) ‐ wound infections | High risk | Blinding of outcome assessor not discussed. Outcome assessor unlikely to be adequately blinded with an intervention of this nature. |
Blinding of outcome assessor (detection bias) ‐ intraabdominal abscesses | Unclear risk | NA‐ not assessed |
Blinding of outcome assessor (detection bias) ‐ postoperative complications e.g. acute myocardial infarction, thrombosis or pneumonia | High risk | (Pneumonia, toxic hepatitis, sepsis, evisceration, cerebral infarct) Blinding of outcome assessor not discussed. Outcome assessor unlikely to be adequately blinded with an intervention of this nature. |
Blinding of outcome assessor (detection bias) ‐ anastomotic leakage/dehiscence | High risk | Blinding of outcome assessor not discussed. Outcome assessor unlikely to be adequately blinded with an intervention of this nature. |
Blinding of outcome assessor (detection bias) ‐ mortality | Low risk | Blinding of outcome assessor not discussed. Outcome assessor unlikely to affect this outcome. |
Blinding of outcome assessor (detection bias) ‐ adverse events (e.g. nausea, vomiting, abdominal distention, aspiration, tube blockage and any other adverse events | Unclear risk | NA‐ not assessed |
Blinding of outcome assessor (detection bias) ‐ length of hospital stay | High risk | Blinding of outcome assessor not discussed. Outcome assessor unlikely to be adequately blinded with an intervention of this nature. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts after randomisation not reported. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. All outcomes listed in methods were reported in the results. |