Am. Keele et al., 2 PHASE RANDOMIZED CONTROLLED CLINICAL-TRIAL OF POSTOPERATIVE ORAL DIETARY-SUPPLEMENTS IN SURGICAL PATIENTS, Gut, 40(3), 1997, pp. 393-399
Background-Previous work has shown that the administration of oral die
tary supplements to patients who have undergone gastrointestinal surge
ry results in clinically significant short term benefits. Aims-This st
udy aimed firstly to re-evaluate these short term effects, and secondl
y to establish whether there are any long term benefits. Subjects-One
hundred patients admitted for elective moderate or major gastrointesti
nal surgery. Methods-In the inpatient phase, patients were randomised
to receive a normal ward diet postoperatively, or the same diet supple
mented with an oral dietary supplement. In the outpatient phase, patie
nts were further randomised to receive their home diet, or their home
diet suppplemented with the oral dietary supplement for four months. R
esults-During the inpatient phase, patients treated with oral suppleme
nts had a significantly improved nutritional intake and lost less weig
ht (2 . 2, 95% confidence interval (95% CI) 0 . 9 kg) compared with co
ntrol patients (4 . 2 (0 . 78) kg, p<0 . 001). Supplemented patients m
aintained their hand grip strength whereas control patients showed a s
ignificant reduction in grip strength (p<0 . 01). Subjective levels of
fatigue increased significantly above pre-operative levels in control
patients (p<0 . 01) but not in the supplemented group. Twelve patient
s in the control group developed complications compared with four in t
he supplemented group (p<0 . 05). In the outpatient phase, supplemente
d patients had improved nutrient intakes but there were no significant
differences in indices of nutritional status or wellbeing between the
groups. Conclusions-The prescription of oral dietary supplements to p
atients who have undergone gastrointestinal surgery results in clinica
lly significant benefits. These benefits, however, are restricted to t
he inpatient phase.