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Completed

NCT Number: NCT00512213

Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Visceral Surgery, University Hospital Center

Lausanne, 1011, Switzerland

About this study

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].

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Immunonutrition for 5 days preoperative

Dietary Supplement

Impact vs Meritene

Other names: Impact, Meritene

Standard enteral nutrition for 5 days preoperative

Dietary Supplement

Impact vs Meritene

Other names: Impact vs Meritene

Primary outcomes

  1. complications after surgery

    Time frame: 30 days

Secondary outcomes

  1. hospital stay, patient compliance, Interleukin-6 and 10 plasma level

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 7, 2007
Registry last updated
Apr 24, 2012

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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