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
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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 |
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 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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Immunonutrition containing RNA, omega-3-FAs, arginine
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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
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Dietary Supplement: Standard enteral nutrition for 5 days preoperative
Impact vs Meritene
Other Name: Impact vs Meritene |
- complications after surgery [ Time Frame: 30 days ]
- hospital stay, patient compliance, Interleukin-6 and 10 plasma level [ Time Frame: 30 days ]

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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 |
Inclusion Criteria:
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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.

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
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 |
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 |