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Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery

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ClinicalTrials.gov Identifier: NCT00512213
Recruitment Status : Completed
First Posted : August 7, 2007
Last Update Posted : April 24, 2012
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals

Study Description
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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.


Condition or disease Intervention/treatment Phase
Major Abdominal Surgery Dietary Supplement: Immunonutrition for 5 days preoperative Dietary Supplement: Standard enteral nutrition for 5 days preoperative Not Applicable

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].


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery: A Single-center Double-blinded Controlled Randomized Superiority Trial
Study Start Date : September 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Immunonutrition containing RNA, omega-3-FAs, arginine
 Dietary Supplement: Immunonutrition for 5 days preoperative
Impact vs Meritene
Other Name: Impact, Meritene
Active Comparator: 2
Standard enteral nutrition: isocaloric and isonitrogeneous but w/o active ingredients
 Dietary Supplement: Standard enteral nutrition for 5 days preoperative
Impact vs Meritene
Other Name: Impact vs Meritene


Outcome Measures
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Primary Outcome Measures :
  1. complications after surgery [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. hospital stay, patient compliance, Interleukin-6 and 10 plasma level [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512213


Locations
Switzerland
Department of Visceral Surgery, University Hospital Center
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Novartis
Investigators
Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
More Information
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Responsible Party: Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00512213     History of Changes
Other Study ID Numbers: P00/07 CHV
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by Nicolas DEMARTINES, University of Lausanne Hospitals:
preoperative Immunonutrition
major abdominal surgery
complication