Standard and immunomodulating enteral nutrition in patients after extended gastrointestinal surgery--a prospective, randomized, controlled clinical trial.

Background & Aim: The immunomodulating enteral diets are intended to reduce the incidence of postoperative complications in surgical patients. The aim of the study was to assess the clinical effect of such nutrition.
Materials and Methods: Between June 2004 and September 2007 196 well-nourished patients undergoing resection for pancreatic and gastric cancer were randomized in double-blind manner to receive postoperative enteral nutrition with immunostimulating diet (IMEN group) or standard oligopeptic diet (SEN group). Outcome measures were: number and type of complications, length of hospital stay, mortality, treatment tolerance, liver and kidney function.
Results: One hundred and ninety six patients were initially enrolled, finally 183 patients (91 SEN, 92 IMEN group; 69 F, 114 M, median age 61.2) were analyzed. Median postoperative hospital stay was 12.4 days (SD 5.9) in SEN and 12.9 days (SD 8.0) in IMEN group (p=0.42). Complications were observed in 21 patients (23.1%) in SEN and 23 (25.2%) in IMEN group (p>0.05). Four (4.4%) patients in SEN group and 4 (4.4%) in IMEN had surgical complications (p>0.05). There were no differences in liver and kidney function, visceral protein turnover and treatment tolerance.
Conclusion: Results of our study showed no benefit of immunomodulating enteral nutrition over standard enteral nutrition in patients after major gastrointestinal surgery. The Trial was registered in Clinical Trials Database--number: NCT00576940.