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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00512213 |
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Date of registration:
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06/08/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery
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Scientific title:
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Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery: A Single-center Double-blinded Controlled Randomized Superiority Trial |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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154 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00512213 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Nicolas Demartines, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Abdominal Surgery
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Intervention(s)
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Dietary Supplement: Standard enteral nutrition for 5 days preoperative
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Dietary Supplement: Immunonutrition for 5 days preoperative
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Primary Outcome(s)
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complications after surgery
[Time Frame: 30 days]
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Secondary Outcome(s)
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hospital stay, patient compliance, Interleukin-6 and 10 plasma level
[Time Frame: 30 days]
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Secondary ID(s)
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P00/07 CHV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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