Outcome and cost-effectiveness of perioperative enteral immunonutrition in patients undergoing elective upper gastrointestinal tract surgery: a prospective randomized study.

HYPOTHESIS: Perioperatively administered enteral immunonutrition will improve early postoperative morbidity and cost-effectiveness after gastrointestinal tract surgery. DESIGN: A prospective, randomized, double-blind, multicenter clinical trial. SETTING: Surgical departments in German university and teaching hospitals. PATIENTS: One hundred fifty-four patients with upper gastrointestinal tract malignant neoplasms who were eligible for analysis. INTERVENTION: Preoperatively, patients received 5 days of oral immunonutrition (an arginine-, RNA-, and omega3 fatty acid-supplemented diet) or an isoenergetic control diet (1 L/d). Early postoperative enteral feeding with immunonutrition or an isoenergetic, isonitrogenous control diet using a catheter jejunostomy was performed for 10 days. MAIN OUTCOME MEASURES: Postoperative infectious complications, their treatment costs, and cost-effectiveness of immunonutrition were analyzed. Plasma levels of the fatty acids eicosapentaenoic acid and docosahexaenoic acid were measured. RESULTS: In the immunonutrition group, significantly fewer infectious complication events occurred (14 vs 27; P = .05). The number of patients with complications was significantly lower in the supplemented diet group after postoperative day 3 (7 vs 16; P = .04). The treatment costs of complications in the supplemented diet group were suggestively lower than in the control diet group (DM 75172 vs DM 204273). Cost-effectiveness was DM 1503 in the experimental group vs DM 3587 in the control group, where DM denotes deutsche mark (German currency). CONCLUSION: The perioperative administration of an enteral immunonutrition significantly (P = .05) decreased the early occurrence of postoperative infections and reduced substantially the treatment costs of the complications after major upper gastrointestinal tract surgery.

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.

[A new model for economic studies of therapies exemplified by postoperative parenteral nutrition]. / Ein neues Modell zur Wirtschaftlichkeitsuntersuchung von Therapien am Beispiel der postoperativen parenteralen Ernährung.

In this economic evaluation we compared the costs of a new therapeutic system (two-chamber bag) in total parenteral nutrition (TPN) with the comparative standard therapeutic systems (multiple-bottle system in intensive care patients followed by a combination solution (glass bottles) on the ward). In the model, standard treatment algorithms of a 10-day course TPN for patients after major gastric surgery were specified for both application systems, the two-chamber bag and the comparative system. Based on the standard treatment pattern, the resource utilisation (manpower services, medical needs, material) was assessed. In a base case analysis the types and amounts of resources were valued using salaries, prices and tariffs to assess the costs. The costs per day and per case of the therapeutic systems were compared. Sensitivity analyses were carried out to validate the cost-estimates. The total costs per patient of the two-chamber bag amounted to DM 2324.41, which was substantially less than the DM 2728.99 cost of the comparative system. The average daily costs for the two-chamber bag system were 12% to 23% lower than for the comparative system. The results were shown to be valid for the whole range of tested parameters. This model makes it possible to obtain an economic evaluation of various therapeutic modalities without undertaking a prospective randomized study with the attendant high time and cost requirements.

[Optimal and computer-assisted hospital cost control by the surgeon]. / Optimiertes und computergestütztes Erlöscontrolling durch den Chirurgen.

Considering the legal conditions there is no question that with the health reform law (GSG) changes in hospital infrastructure have to be made by the surgeon and the administration cojointly. From our experience an efficient budget control needs a complete and correct data recording--employing an efficient software--as well as strict medical control of profits along with continuous communication between the surgeons themselves and with the administration.

[Postoperative complications in abdominal surgery--what do they cost?]. / Postoperative Komplikationen in der Abdominalchirurgie--was kosten sie?

In this study of 154 patients with major abdominal cancer surgery, 41 postoperative complications occurred and caused additional total costs of DM 205.993,-, DM 5.024,- per case, respectively, where the special personnel costs were not accounted for. There was a significant difference between single and multiple complications as well as for early and late complication costs. Economic analyses are necessary to determine budgets of medical departments with extended and cost-intensive treatment, such as cancer surgery, to maintain optimal care for the patients.

[Sonographic versus radiological assessment of chronic outer ligament instability of the upper ankle joint]. / Sonographische versus radiologische Beurteilung der chronischen Aussenbandinstabilität am oberen Sprunggelenk.

Chronic instability of the lateral upper ankle joint ligament is usually diagnosed by clinical and radiological examination. For the evaluation of an ultrasound method of testing lateral instability of the ankle joint we carried out a prospective study. We examined 23 adults who were actively engaged in some form of sport (21 male, 2 female, mean age 32 years) and had a preexisting lateral instability of the ankle. The instability was measured in the standard planes using Scheuba's stress apparatus with simultaneous ultrasound monitoring. The ultrasound examination was performed by positioning the 5-MHz applicator on the lateral side of the Achilles tendon, thus defining a plane from which the instability could be measured in both examination planes by observing the deviation between dorsal inferior edge of the tibia and the dorsal border of the talar roll. For the two examination planes, Spearman's rank-correlation coefficient between the radiological and ultrasound methods was 0.83 and 0.92. The sensitivity of the ultrasound method was 0.90, and the specificity was 0.85. Our study showed a good correlation between the two methods. A pathological talar tilt according to radiological criteria was also revealed by ultrasonography. Thus, all the advantages of ultrasound are now available for the evaluation of chronic lateral instability of the ankle joint.