Carr 1996.
Methods | Randomised controlled trial No information provided about duration of study |
|
Participants | 30 participants. 2 participants did not proceed to resection, and their data were not included. 28 participants (14 in each group). Elective gastrointestinal resection Route of feeding: nasojejunal tube Mean (SD) age: 60.1 years (7.5) (intervention group), 51.1 years (8.2) (control group) Male:Female 9:5 (intervention group), 8:6 (control group) |
|
Interventions | Intervention group: feeding started on return from operating theatre by using standard isocaloric feed (Fresubin, Fresenius, Cheshire). Energy and water requirements were calculated from the weight of the patient, and a mixture of Fresubin and water provided the full basic fluid requirements. Initially feeding was at 25 mL an hour and was increased by 25 mL four‐hourly until the target volume was reached, at which point intravenous fluids were stopped. Control group: received intravenous fluids with NBM until passage of flatus. Oral fluids started on passage of flatus and increased to normal diet over 48 hours. Intravenous fluids and enteral feeding were stopped with introduction of diet. |
|
Outcomes | Mortality, LoS, nausea and vomiting | |
Notes | Country of study: UK | |
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 | Patients were randomly allocated by closed envelope. Not reported if sequentially numbered or opaque. |
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 | (Bleeding duodenal ulcer, infection) 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 | Unclear risk | NA – not assessed |
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 | High risk | (Nausea and vomiting, distension, diarrhoea) 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) ‐ 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 | Low risk | Less than 10% missing data |
Selective reporting (reporting bias) | High risk | No protocol available. Some outcomes were reported in methods but not in results (sepsis) and there was a very general statement of clinical outcomes in the methods section (but more detail of complications, adverse events, LoS given in results) |