| Methods |
Method of randomisation: sealed envelopes
Assessor blinding: not blinded
Intention to treat: carried out
Lost to follow‐up: apparently none
Timing of intervention: patients were instructed to drink the supplements in addition to and not in place of their normal diet and continued up until the day before surgery, pre op minimum 10 days mean 15d (5‐59), post op minimum 7 days mean 8d (0‐20), post op supps as soon as oral fluids were permitted up until 4 weeks after discharge. 4 groups; preop supps, postop supps, both, neither |
| Participants |
Location: preoperative outpatient phase and postoperative inpatient phase, combined gastroenterology unit at Scarborough hospital
100 patients
Inclusion criteria: patients requiring major elective gastrointestinal surgery.
Exclusion criteria: dementia, major concurrent, metabolic problems, such as uncontrolled diabetes, advanced liver disease, or uraemia, those requiring emergency surgery. Patients were withdrawn if any member of the clinical or nutrition team considered that adjuvant parenteral or enteral support was indicated or whether it was deemed clinically appropriate to proceed with the surgery within 10 days.
Sex: 54 female, 46 male
Age: mean ages 63, 68, 66, 64y
Health Status: patients receiving gastrointestinal surgery, most patients well nourished |
| Interventions |
a: 2 x 200 mL cartons (Fortisip, Nutricia Ltd) in a variety of flavours providing 1.5 kcal, 0.05 g protein and 0.18 g carbohydrate per ml. A fruit flavoured supplement (fortijuice, Nutritia Ltd) was available as an alternative, providing 1.25 kcal, 0.025 g protein and 0.285 g carbohydrate per ml
b: usual diet
Allocated: 24/24/27/25
Assessed: 24/24/27/25 |
| Outcomes |
Main outcomes:
Mortality
Morbidity and complications ‐ complications (total, septic)
Length of stay ‐ post operative stay
Side effects of treatment ‐ nausea with supplements
Functional status ‐ hand grip, postoperative anxiety and depression
Additional outcomes:
Measures of nutritional status‐
Anthropometric indices ‐ perioperative weight loss, mid upper arm circumference Measures of dietary intake ‐ energy intake |
| Notes |
Analysed 75/25, request for information regarding how many measured for outcomes, why the supplements were stopped, the number of women in group 2 and when the patients died, sent 18/9/01. Reply received 1/10/01 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
