Early postoperative enteral immunonutrition: clinical outcome and cost-comparison analysis in surgical patients.

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.

[Cost savings by disinfection for prevention of surgical wound dehiscence after gastrectomy]. / Kostensenkung durch Dekontamination zur Prävention der Nahtinsuffizienz nach Gastrektomie.

The aim of this study was to examine the effect of decontamination as compared to placebo medication on post-gastrectomy treatment costs. The results of a prospective double-blind placebo-controlled multicenter trial indicate that perioperative i.v. prophylaxis with cefotaxim and topical decontamination with polymyxin B, tobramycin, vancomycin and amphotericin B from the day before surgery until the 7th postoperative day is most effective in the prevention of esophagojejunal anastomotic leakage following total gastrectomy. For the cost analysis, only patients who had been decontaminated according to the study protocol (n = 90) were compared to the non-decontaminated patients (n = 103). The esophagojejunal leakage rate was 10.6% in placebo patients (n = 103) and could be reduced significantly to 1.1% in decontaminated patients (n = 90, P = 0.0061; two-tailed Fisher's exact test). There was only one asymptomatic leakage detected on Gastrografin swallow. The pulmonary infection (P = 0.0173) and overall complication rates (p = 0.0238) were significantly reduced in the decontamination group as well. During the observation period, 9 (8.7%) patients in the placebo group and 3 (3.3%) in the decontaminated group died (P = n.s.). Patients were followed up for the initial 42 postoperative days and treatment costs were calculated for this time period only. The parameters compiled in the study pertaining to use of medical resources formed the basis for the determination of the postoperative treatment costs. These were the costs for decontaminating drugs, intravenous antibiotics, reoperations and non-surgical reinterventions as well as daily treatment costs of the general ward, the intensive care unit (ICU) and rehabilitation. The average costs per patient in the placebo group amounted to DM 20,000 while the costs for decontaminated patients were only DM 16,200, which was due to a significantly lower number of patients requiring treatment in the ICU (P = 0.0082), significantly fewer patients requiring i.v. antibiotics (P = 0.0232) and fewer patients with reoperations (P = 0.0909). The prophylaxis employing decontaminating drugs in the amount of DM 400 lowered post-gastrectomy treatment costs by DM 3800 or 19%. The prophylaxis can be recommended, because it lowers morbidity, mortality and the costs of total gastrectomy.