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A Prospective Randomized Study

Metin Senkal, MD; Volker Zumtobel, MD; Karl-Heinz Bauer, MD; Barbara Marpe, MD; Günther Wolfram, MD; Andreas Frei, MPH; Ulrich Eickhoff, MD; Matthias Kemen, MD

Arch Surg. 1999;134:1309-1316.

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 3 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 75 172 vs DM 204 273). 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.

From the Department of Surgery, Ruhr-University Bochum, St Josef Hospital, Bochum, Germany (Drs Senkal, Zumtobel, Bauer, and Marpe); the Department of Nutritional Sciences, Technical University Munich, Freising/ Weihenstephan, Germany (Dr Wolfram); HealthEcon AG, Basel, Switzerland (Mr Frei); and the Department of Surgery, Evangelisches Krankenhaus Herne, Herne, Germany (Drs Eickhoff and Kemen).

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