The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery

Phase 4

Completed

• Conditions: Gastrointestinal Surgery
• Interventions: Drug: Reconvan, Dipeptiven, Omegaven

• Registration Number: NCT00732849
• Lead Sponsor: Jagiellonian University

Brief Summary

The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients following elective upper GI surgery

Detailed Description

All patients qualified between June 2002 and December 2007 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. Malnutrition was defined by the Nutritional Risk Index (NRI), calculated according to the formula used in the Veterans Administration Cooperative Group trial.{, 1991 #70} Additional eligibility criteria included: age between 18 and 80 years, Karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. Patients without features of malnutrition, as well as those with disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients following elective upper GI surgery. Therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay.

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2002-09
• Study Completion: 2007-11
• Status Verified: 2008-07
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-08
• Last Update Submitted: 2008-08-08
• Study First Posted: 2008-08-12
• Last Update Posted: 2008-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• age between 18 and 80 years,
• Karnofsky performance status score of 80 or more,
• adequate organ function measured by routine blood tests

Exclusion Criteria

• patients <18 or > 80
• Karnofsky performance < 50

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Reconvan, Dipeptiven, Omegaven	Standard Enteral Nutrition - Peptisorb, Nutricia Ltd.
2	Reconvan, Dipeptiven, Omegaven	Standard Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes
3	Reconvan, Dipeptiven, Omegaven	Immunomodulating Enteral Nutrition: Reconvan, Fresenius Kabi Poland
4	Reconvan, Dipeptiven, Omegaven	Immunomodulating Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes + Omegaven (Fresenius Kabi), Dipepitven (Fresenius Kabi)

Primary Outcome Measures

Name	Time	Method
Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients	Immunonutrition

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay	morbidity

Trial Locations

Locations (1)

1st Department of SUegy; 🇵🇱 Krakow, _30978, Poland