CSP #221 is a randomized multiinstitutional clinical trial to assess the efficacy of 10 d of perioperative total parenteral nutrition (TPN) in reducing morbidity and mortality in malnourished patients undergoing intraperitoneal and/or intrathoracic operations. In this paper a detailed protocol for the clinical efficacy trial is presented primarily as a reference document for use in interpretation of the results of the clinical trial. It is also anticipated, however, that review of this protocol may be useful to other investigators planning future clinical nutrition intervention trials.
Most clinicians subjectively feel that malnutrition in surgical patients is associated with poor clinical outcome. This overview provides a chronologic review of studies relating poor nutritional status to increased surgical morbidity. Techniques for identifying surgical patients with clinically important nutritional deficits are discussed. Retrospective and/or non-randomized clinical studies evaluating the efficacy of perioperative forced feeding are reviewed. These data suggest a possible role for preoperative nutritional support of selected malnourished surgical candidates and provide the rationale for a large-scale nutrition-intervention clinical trial.
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