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| Sponsors and Collaborators: |
University of Lausanne Hospitals Novartis |
|---|---|
| Information provided by: | University of Lausanne Hospitals |
| ClinicalTrials.gov Identifier: | NCT00512213 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery: A Single-Center Double-Blinded Controlled Randomized Superiority Trial |
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2008 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Immunonutrition
|
Dietary Supplement: Immunonutrition for 5 days preoperative |
|
2: Active Comparator
Standard enteral nutrition
|
Dietary Supplement: Standard enteral nutrition for 5 days preoperative |
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 |
Inclusion Criteria:
All patients admitted for elective major abdominal surgery:
Exclusion Criteria:
Contacts and Locations| Contact: Martin Hubner, MD | +41 21 314 2418 | martin.hubner@chuv.ch |
| Contact: Sven Muller, MD | +41 21 314 2325 | sven.muller@chuv.ch |
| Switzerland | |
| Department of Visceral Surgery, University Hospital Center | |
| Lausanne, Switzerland, 1011 | |
| Study Chair: | Nicolas Demartines, MD | Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland |
More Information
| Study ID Numbers: | P00/07 CHV |
| Study First Received: | August 6, 2007 |
| Last Updated: | August 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00512213 |
| Health Authority: | Switzerland: Ethikkommission |
|
preoperative Immunonutrition, major abdominal surgery, complication |
