Immunomodulating versus high-protein oral preoperative supplement in surgical patients - A two-center, prospective, randomized clinical trial.

ABSTRACT

OBJECTIVES: For many years, immunonutrition was believed to reduce postoperative complications in patients undergoing major abdominal surgery. However, recent studies questioned that belief. Moreover, the perioperative intake of proteins has gained more and more attention and has shown clinical value. Therefore, the aim of this study was to compare the clinical effect of immunomodulating (IM) plus high-protein (HP) and pure HP supplements during the preoperative period. METHODS: Between January 2011 and December 2020, 299 well-nourished patients (130 female and 169 male; mean age 60.8 y) undergoing major abdominal surgery at two surgical centers were randomized to receive either preoperative IM or HP oral supplements for 7 d after surgery. In all patients, an enhanced recovery after surgery protocol was applied. Outcome measures of the intend-to-treat analysis were number and type of complications, length of hospitalization, and mortality. RESULTS: Both groups were comparable in terms of age, sex, and type of surgery. The median length of postoperative hospital stay was 8 d (range, 6-12 d) in the IM group and 7 d (range, 6-10 d) in the HP group (P = 0.153). Postoperative complications were observed in 29 patients (21.3%) in the IM group and 28 (17.8%) in the HP group (P = 0.442) The risk of readmission was comparable (5.1% vs 4.9%; P = 0.924) for IM and HP supplements, respectively. Postoperative nausea and vomiting occurred in 21 patients in the IM group (15.4%) and 17 patients in the HP group (10.4%; P = 0.195). No difference in gastrointestinal function evaluated with time to first flatus was observed (P = 0.272) CONCLUSIONS: The study demonstrated no difference between preoperative IM + HP and HP supplements in surgical patients. Therefore, the routine preoperative use of IM supplements in all surgical patients cannot be recommended.