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

The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00732849
Enrollment
600
Registered
2008-08-12
Start date
2002-06-30
Completion date
2007-11-30
Last updated
2008-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Surgery

Keywords

immunonutrition, surgical patients, postoperative period

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.

Interventions

DRUGReconvan, Dipeptiven, Omegaven

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

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patientsImmunonutrition

Secondary

MeasureTime frame
To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital staymorbidity

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026