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Perioperative immunonutrition in patients undergoing cancer surgery: results of a randomized double-blind phase 3
M Braga1, L Gianotti, G Radaelli
1Department of Surgery, Scientific Institute San Raffaele Hospital, Milan, Italy. braga.marco@hsr.it
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 enteral formula (n = 104) or the same formula enriched with arginine, RNA, and omega3 fatty acids (n = 102) for 7 consecutive days before surgery. The 2 diets were isoenergetic and isonitrogenous. Jejunal infusion with the same formulas was started 6 hours after operation and continued until postoperative day 7.
Main Outcome Measures:
Rate of postoperative infectious complications and length of hospital stay.
Results:
Both groups were comparable for age, sex, weight loss, Karnofsky scale score, nutritional status, hemoglobin level, duration of surgery, blood loss, and rate of homologous transfusion. Intent-to-treat analysis showed a 14% (14/102) infectious complication rate in the supplemented group vs 30% (31/104) in the control group (P = .009). In the eligible population, the 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 postoperative 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 patients undergoing surgery for cancer.