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The purpose of the study is to examine whether postoperative nutrition with endeavours of 100% coverage of the patient's estimated energy and protein needs, can reduce the incidence of postoperative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Supplementary parenteral nutrition |
|
| Control group | No Intervention | The control group will receive standard nutritional care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral Nutrition | Other | Supplementary parenteral nutrition to achieve 100% coverage of estimated needs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Infectious Complications | Local and systemic | At day 30 |
| Postoperative Thrombotic Complications | At day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Fistula formation without infection defined by journal documentation | The measurement that will be used is documented fistula formation in the patients´ journal without increased infection parameters (c-reactive protein and leukocytes) | Day 1,2,3,4,7,14, 23 and 30 |
| Number of participants who develop Refeeding Syndrome defined as a decrease in p-phosphate and clinical symptoms of refeeding syndrome; edema, dyspnea, hypertension, arrhythmia, confusion and/ or cases of spasm. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Changes in Liver Parameters; p-alanine aminotransferase, p-bilirubin, alkaline phosphatase and INR (international normalized ratio). | Baseline and Day 2,3,4 | |
| Number of patients who develop coagulopathy defined as increase in INR (international normalized ratio) above the reference level. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Ear, Nose and Throat Surgery, Rigshospital | Copenhagen | 2100 Cph OE | Denmark |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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Data are collected from the patient's record. |
| Day 2,3,4 |
| Number of participants who develop Refeeding Phenomena defined as a decrease in p-phosphate without clinical symptoms of refeeding syndrome; edema, dyspnea, hypertension, arrhythmia, confusion and/ or cases of spasm. | Data will be collected from the patient's record. | Day 2,3,4 |
| Length of stay at the hospital | Up to 30 days |
| Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration. | Day 1,2,3,4 |
| Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration. | Day 1,2,3, 4 |
| Hand Grip Strength measured by a hand grip strength dynamometer in kilograms. | Baseline and Day 2,3,4 |
| Baseline and Day 2,3,4 |
| Presence of nausea under treatment measured by a VAS-scale (visual analogue scale). | Day 2,3,4 |
| Presence of oedema measured by weight in kg. | Day 2,3,4 |
| Causes of insufficient dietary intake, measured by a questionnaire filled out by the patient. | Day 2,3,4 |
| Presence of vomiting under treatment registered by patient reported cases. | Day 2,3,4 |