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The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Oral nutritional supplement: assignment according to consecutive random numbers. |
|
| Control | Placebo Comparator | Assignment according to consecutive random numbers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PreOP Booster (food for special medical purposes) | Dietary Supplement | 3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia; |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoinflammatory parameters | on day -2, -1, 1, 2, 3, 5, and 7 | |
| Antioxidant / oxidant parameters | on day -2, 1, 3, 5, and 7 | |
| Ischemia / reperfusion injury parameters | on day -2, 1, 3, 5, and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| pre-and postoperative discomfort (well-being) | on day -1, and 0 | |
| hand grip strength | on day -2, 1, 2, 3, 5, and 7 | |
| GI tolerance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A.M. van Leeuwen, Prof. | University Hospital Amsterdam; The Netherlands | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Alkmaar | Alkmaar | Netherlands |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| on day -1, 0, 1, 2, and 7 |
| Safety | on day -1, 0, 1, 2, 3, 5, and 7 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |