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

Arch Surg. 1999 Apr;134(4):428-33. doi: 10.1001/archsurg.134.4.428.


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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Bacterial Infections / prevention & control*
  • Double-Blind Method
  • Enteral Nutrition*
  • Female
  • Food, Formulated*
  • Gastrointestinal Neoplasms / immunology
  • Gastrointestinal Neoplasms / surgery*
  • Humans
  • Male
  • Middle Aged
  • Postoperative Care*
  • Postoperative Complications / immunology
  • Postoperative Complications / prevention & control*
  • Preoperative Care*
  • Prospective Studies