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interim review of the data indicated that the hypothesis put forth on the efficacy of a 3 day regimen was not met.
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Major surgery is still associated with a high rate of postoperative morbidity despite improved techniques in surgical management. Surgery-induced alterations of the immune system are well described and may play a role in the genesis of postoperative complications. It has been shown by several large scale clinical trials, that the use of immunonutrition in postoperative cancer surgery, trauma and critically ill patients resulted in an improved immunocompetence and/or reduced postoperatively infectious morbidity and/or length of hospital stay.The pre-operative regimen was between 5 to 7 days of treatment. The aim of this trial is to evaluate if a shorter administration of 3 days pre-operatively would be beneficial as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional product | Active Comparator | Oral nutritional supplement containing immuno nutrients |
|
| Isocaloric control | Placebo Comparator | Isocaloric and isonitrogenous control without immuno nutrients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunonutrition | Dietary Supplement | Oral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of post-operative complications | On the day of discharge from hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of non-infectious complications | On the day of discharge from hospital | |
| Length of hospital stay | On the day of discharge from hospital | |
| Nutritional status evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Aarau | 5001 | Switzerland | |||
| Kantonsspital Baden |
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| On the day of discharge from hospital |
| Rate of post-operative infectious complications | On the day of discharge from hospital |
| Baden |
| 5404 |
| Switzerland |
| Lindenhof-Spital | Bern | 3012 | Switzerland |
| Kantonsspital Liestal | Liestal | 4410 | Switzerland |
| Kantonsspital St.Gallen | Sankt Gallen | 9000 | Switzerland |
| Kantonsspital Schaffausen | Schaffhausen | 8208 | Switzerland |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000093702 | Immunonutrition Diet |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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