Standard and Immunostimulating Enteral Nutrition in Surgical Patients
Condition: Gastric Cancer; Pancreatic Cancer
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was to assess the clinical effect of immunomodulating enteral nutrition
      in patients undergoing resection for gastrointestinal cancer. 196 subjects were randomly
      assigned into two study groups: standard and immunostimulating. The study failed to
      demonstrate any clear advantage of routine postoperative immunonutrition in patients
      undergoing elective upper gastrointestinal surgery
    

Detailed description: 
      Background&Aim: The administration of immunomodulating enteral diets during postoperative
      period in patients after major gastrointestinal surgery is intended to reduce the number of
      postoperative complications and to shorten the hospital stay. The aim of the study was to
      assess the clinical effect of enteral immunostimulatory nutrition in surgical patients.

      Material and Methods: 196 patients undergoing resection for pancreatic and gastric cancer
      were randomized in double-blind manner to receive early postoperative enteral nutrition with
      immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3
      fatty acids) or oligopeptic control (SEN group) between June 2004 and September 2007. Enteral
      nutrition was started 6 hours after surgery and continued for 7 days, up to target volume of
      100 ml/h. All malnourished patients requiring preoperative nutritional therapy were excluded
      for the study and treated preoperatively. Outcome measures were: number and type of
      complications, length of hospital stay, mortality, treatment tolerance, liver and kidney
      function.

      Results: One hundred eighty-three patients (91 in SEN, 92 in IMEN group, 69 F, 114 M, mean
      age 61.2) of 196 initially enrolled were analyzed. There were 2 deaths in both groups. Median
      postoperative hospital stay was 12.4 days (SD 5.9) in SEN group 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). 4 (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 concentration and treatment tolerance.

      Conclusion: Clinical and laboratory parameters show no benefit of immunomodulating enteral
      nutrition over standard enteral nutrition in patients after major gastrointestinal surgery as
      far as complications, hospital stay, mortality and treatment tolerance and safety are
      considered.
    

Intervention name(s): Reconvan; Peptisorb
Intervention type(s): Drug; Drug
Intervention description(s): isocaloric, immunomodulating entral diet; isocaloric, isopeptic standard diet
Other intervention name(s): oligopeptic immunostimulatory diet; standard enetral diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: enteral nutrition, immunomodulating nutrition