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Results of a Randomized Double-blind Phase 3 Trial

Marco Braga, MD; Luca Gianotti, MD, ScD; Giovanni Radaelli, PhD; Andrea Vignali, MD; Gilberto Mari, MD; Oreste Gentilini, MD; Valerio Di Carlo, MD

Arch Surg. 1999;134:428-433.

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 3 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.

From the Department of Surgery, Scientific Institute San Raffaele Hospital (Drs Braga, Gianotti, Vignali, Mari, Gentilini, and Di Carlo), and Department of Informative Systems, University of Milan (Dr Radaelli), Milan, Italy.

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