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Clinical Trials/NCT00512213
NCT00512213
Completed
Not Applicable

Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery: A Single-center Double-blinded Controlled Randomized Superiority Trial

University of Lausanne Hospitals1 site in 1 country154 target enrollmentSeptember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Abdominal Surgery
Sponsor
University of Lausanne Hospitals
Enrollment
154
Locations
1
Primary Endpoint
complications after surgery
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The aim of this trial is to compare preoperative Imunnonutrition with standard enteral nutrition regarding morbidity after major abdominal surgery in patients with NRS greater 3.

The primary end point is the complication rate until 30 days after surgery.

Detailed Description

Malnutrition affects about 20-50% of all patients in hospital \[1, 2\]. Major surgery further increases postoperative malnutrition and immunity reduction. Therefore, postoperative complication and infection rates after major surgery exceed 30% \[3-6\]. The nutritional risk score (NRS) \[1\] is based on the ESPEN (European society of parenteral and enteral nutrition) screening guidelines and identifies patients who are likely to benefit from nutritional support. Patients with a NRS ≥ 3 are considered severely undernourished, or to have a certain degree of severity of disease in combination with certain degree of malnutrition \[7\]. In a prospective cohort study patients with a NRS ³ 3 had significant more infectious and overall complications after major abdominal surgery \[4, 7, 8\]. Several studies showed a benefit by nutritional support on complications \[3, 5, 6\]. International guidelines suggest therefore preoperative oral nutritional support for malnourished patients undergoing major surgery \[9\]. However, it remains controversial whether standard enteral nutrition (SEN) or immunonutrition (IN) is preferable \[9\]. IN, containing arginine, ribonucleic acid and omega-3 polyunsaturated fatty acids aims to improve the nutritional status, immunological function and clinical outcome \[5, 10\].

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
December 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Lausanne Hospitals
Responsible Party
Principal Investigator
Principal Investigator

Nicolas DEMARTINES

professor of surgery

University of Lausanne Hospitals

Eligibility Criteria

Inclusion Criteria

  • All patients admitted for elective major abdominal surgery:
  • Open and laparoscopic esophageal, gastric, hepatic, pancreatic, intestinal and colorectal surgery and with a NRS ≥ 3.

Exclusion Criteria

  • Age \< 18 years
  • No informed consent
  • Emergency situation
  • Patients not speaking french or german.

Outcomes

Primary Outcomes

complications after surgery

Time Frame: 30 days

Secondary Outcomes

  • hospital stay, patient compliance, Interleukin-6 and 10 plasma level(30 days)

Study Sites (1)

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