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The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | oral nutritional supplement (assignment: according to consecutive random numbers) |
|
| Control | Placebo Comparator | placebo (assignment: according to consecutive random numbers) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PreOP Booster (oral nutritional supplement, food for special medical purposes) | Dietary Supplement | 3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters reflecting pathophysiological functions of the liver | day -1, 0, 1, and 7 | |
| Gastrointestinal tolerance | day 0 before and 6-8h after surgery | |
| Metabolic parameters in serum, liver and muscle tissue | on day -1, 0, 1, and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical parameters (infectious and non-infectious complications) | until day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dileep N. Lobo, MS, DM, FRCS | Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals; | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals; | Nottingham | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22444237 | Derived | Awad S, Stephens F, Shannon C, Lobo DN. Perioperative perturbations in carnitine metabolism are attenuated by preoperative carbohydrate treatment: Another mechanism by which preoperative feeding may attenuate development of postoperative insulin resistance. Clin Nutr. 2012 Oct;31(5):717-20. doi: 10.1016/j.clnu.2012.02.015. Epub 2012 Mar 22. | |
| 20622656 |
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| Awad S, Constantin-Teodosiu D, Constantin D, Rowlands BJ, Fearon KC, Macdonald IA, Lobo DN. Cellular mechanisms underlying the protective effects of preoperative feeding: a randomized study investigating muscle and liver glycogen content, mitochondrial function, gene and protein expression. Ann Surg. 2010 Aug;252(2):247-53. doi: 10.1097/SLA.0b013e3181e8fbe6. |
| 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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