Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00512213
First received: August 6, 2007
Last updated: April 21, 2012
Last verified: April 2012
  Purpose

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 Intervention
Major Abdominal Surgery
Dietary Supplement: Immunonutrition for 5 days preoperative
Dietary Supplement: Standard enteral nutrition for 5 days preoperative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • complications after surgery [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hospital stay, patient compliance, Interleukin-6 and 10 plasma level [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 154
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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].

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 6, 2007
Last Updated: April 21, 2012
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on September 22, 2014