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

NCT ID: NCT00732849

Last Updated: 2008-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Surgery

Keywords

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immunonutrition surgical patients postoperative period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard Enteral Nutrition - Peptisorb, Nutricia Ltd.

Group Type NO_INTERVENTION

Reconvan, Dipeptiven, Omegaven

Intervention Type DRUG

Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.

2

Standard Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes

Group Type NO_INTERVENTION

Reconvan, Dipeptiven, Omegaven

Intervention Type DRUG

Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.

3

Immunomodulating Enteral Nutrition: Reconvan, Fresenius Kabi Poland

Group Type EXPERIMENTAL

Reconvan, Dipeptiven, Omegaven

Intervention Type DRUG

Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.

4

Immunomodulating Parenteral Nutrition: Aminomel, Lipofundin, Glucose, Cernevit, Tracutil, electrolytes + Omegaven (Fresenius Kabi), Dipepitven (Fresenius Kabi)

Group Type EXPERIMENTAL

Reconvan, Dipeptiven, Omegaven

Intervention Type DRUG

Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.

Interventions

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Reconvan, Dipeptiven, Omegaven

Reconvan (1ml=1 kcal), 30 kcal/kg b.w. Omegaven 1 ml/ kg b.w. Dipeptiven 1 ml/ kg b.w.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Jagiellonian University

Principal Investigators

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Stanislaw Klek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

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1st Department of SUegy

Krakow, _30978, Poland

Site Status

Countries

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Poland

Other Identifiers

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surg nutr

Identifier Type: -

Identifier Source: org_study_id