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The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preOP booster | Experimental |
| |
| preOP booster placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preOP booster (oral nutritional supplement, food for special medical purposes) | Dietary Supplement | 3x1 dosage pre-operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP; | up to 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance | up to 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Braga, Prof MD | Università Salute-Vita San Raffaele, Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Salute-Vita San Raffaele, | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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