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Completed

NCT Number: NCT00732849

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

1st Department of SUegy

Krakow, _30978, 307981, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reconvan, Dipeptiven, Omegaven

Drug

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

Primary outcomes

  1. Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients

    Time frame: Immunonutrition

Secondary outcomes

  1. To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay

    Time frame: morbidity

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2002
Study completion
2007
First posted
Aug 12, 2008
Registry last updated
Aug 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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