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

Gastrointestinal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732849
• Other study ID #: surg nutr
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2008
• Last updated: August 8, 2008
• Start date: June 2002
• Est. completion date: November 2007

Study information

• Verified date: July 2008
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 2007
• Est. primary completion date: September 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Surgery

Intervention

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

Locations

Country	Name	City	State
Poland	1st Department of SUegy	Krakow	_30978

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients		Immunonutrition	Yes
Secondary	To evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay		morbidity	Yes