Objective: To determine if early postoperative feeding of patients with upper gastrointestinal malignancy, using an enteral diet supplemented with arginine, dietary nucleotides, and omega-3 fatty acids (IMPACT, Sandoz Nutrition, Bern, Switzerland) results in an improved clinical outcome, i.e., reduced infectious and wound complications and decreased treatment costs when compared with an isocaloric, isonitrogenous control diet.
Design: A prospective, randomized, placebo-controlled, double-blind, multicenter trial of the clinical outcome and a retrospective cost-comparison analysis.
Setting: Surgical intensive care units in three different German university hospitals.
Patients: Of 164 patients enrolled in the study, 154 patients were eligible for analysis. They were admitted to the intensive care unit after upper gastrointestinal surgery for cancer and they received an enteral diet via needle catheter jejunostomy. Infectious complications were defined as sepsis or systemic inflammatory response syndrome, pneumonia, urinary tract infection, central venous catheter sepsis, wound infection, and anastomotic leakage. The complication events were prospectively divided into two groups: early (postoperative days 1 to 5) and late (after the fifth postoperative day) postoperative complications. The treatment costs of each complication were analyzed and compared in both groups.
Interventions: Patients were randomized to receive either the immunonutritional diet (n = 77) or an isocaloric and isonitrogenous placebo diet (n = 77). Enteral feeding was initiated 12 to 24 hrs after surgery, starting with 20 mL/hr and advanced to a target volume of 80 mL/hr by postoperative day 5.
Measurements and main results: Clinical examination and adverse gastrointestinal symptoms were recorded on a daily basis. Both groups tolerated early enteral feeding well, and the rate of tube feeding-related complications was low. Postoperative complications occurred in 17 patients in the immunonutrition group vs. 24 patients in the control group (NS). Further, in the early phase (postoperative day 1 to 5), complications occurred to a similar extent in both groups (12 patients in the immunonutritional group vs. 11 patients in the control group). However, in the late phase (after postoperative day 5), considerably fewer patients in the experimental diet group experienced complications compared with the control group (5 vs. 13, p < .05). In addition, the frequency rate of complicating events were recorded in each group. In the experimental diet group, a total of 22 complicating events were recorded vs. a total of 32 events in the placebo diet group (NS). However, the occurrence of late complicating events, i.e., complicating events after the fifth postoperative day, was significantly reduced in the immunonutrition group when compared with the control group (8 vs. 17 events, p < .05). The total costs for the treatment of the complications were 83,563 German marks in the experimental diet group vs. 122,430 German marks in the control group, resulting in a cost-reduction of 38,867 German marks. (At the end of December 1995, the conversion rate from German marks to U.S. dollars was 1.4365 German marks to $1.00.)
Conclusions: Early enteral feeding with an arginine, dietary nucleotides, and omega-3 fatty acids supplemented diet, as well as an isonitrogenous, isocaloric control diet (placebo) were well tolerated in patients who underwent upper gastrointestinal surgery. In patients who received the supplemented diet, a significant reduction in the frequency rate of late postoperative infectious and wound complications was observed. Thereby, the treatment costs were substantially reduced in the immunonutrition group as compared with the control group.