The immunomodulating enteral nutrition in malnourished surgical patients - a prospective, randomized, double-blind clinical trial.

BACKGROUND & AIM: The immunomodulating nutrition was supposed to reduce the incidence of complications in surgical patients, but many authors have questioned its value recently. The aim of the study was to assess the impact of enteral immunonutrition in postoperative period.

METHODS

Between January 2003 and December 2009, 305 malnourished patients (123 F, 182 M, m. age 60.8) undergoing resection for pancreatic or gastric cancer, after preoperative 14 days of parenteral feeding, were randomized in double-blind manner to receive either postoperative immunomodulating enteral diet (IMEN) or standard oligopeptide diet (SEN). Outcome measures of the intend-to-treat analysis were: number and type of complications, length of hospitalization, mortality, and vital organ function.

RESULTS

Median postoperative hospital stay was 17.1 days in SEN and 13.1 days in IMEN group (p = 0.006). Infectious complications were observed in 60 patients (39.2%) in SEN and 43 (28.3%) in IMEN group (p = 0.04). Differences were also observed in overall morbidity (47.1 vs 33.5%, p = 0.01) and mortality (5.9 vs 1.3%, p = 0.03), but the ratio of surgical complications, organ function, and treatment tolerance did not differ.

CONCLUSIONS

The study proved that postoperative immunomodulating enteral nutrition should be the treatment of choice in malnourished surgical cancer patients. The Clinical Trials Database registry number: NCT00576940.