Perioperative immunonutrition in patients undergoing cancer surgery - Results of a randomized double-blind phase 3 trial

Hypothesis: Perioperative administration of a supplemented enteral formula may reduce the rate of postoperative infections. Design: Prospective, randomized, double-blind clinical trial. Setting: Department of surgery at a university hospital. Patients: Two hundred six patients with neoplasm of colorectum, stomach, or pancreas. Intervention: Patients were randomized to drink 1 L/d of either a control e nteral formula (n = 104) or the same formula enriched with arginine, RNA, a nd omega 3 fatty acids (n = 102) for 7 consecutive days before surgery. The 2 diets were isoenergetic and isonitrogenous. Jejunal infusion with the sa me formulas was started 6 hours after operation and continued until postope rative day 7. Main Outcome Measures: Rate of postoperative infectious complications and l ength of hospital stay. Results: Both groups were comparable for age, sex, weight loss, Karnofsky s cale score, nutritional status, hemoglobin level, duration of surgery, bloo d loss, and rate of homologous transfusion. Intent-to-treat analysis showed a 14% (14/102) infectious complication rate in the supplemented group vs 3 0% (31/104) in the control group (P = .009). In the eligible population, th e postoperative infection rate was 11% (9/85) in the supplemented group vs 24% (21/86) in the control group (P = .02). The mean SD length of postopera tive stay was 11.1 +/- 4.4 days in the supplemented group and 12.9 +/- 4.6 in the control group (P = .01). Conclusion: Perioperative administration of a supplemented enteral formula significantly reduced postoperative infections and length of stay in patien ts undergoing surgery for cancer.