Head and Neck Neoplasm
Conditions
Keywords
Supplementary Parenteral Nutrition, Postoperative Nutrition, Postoperative complications
Brief summary
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.
Interventions
OTHERParenteral Nutrition
Supplementary parenteral nutrition to achieve 100% coverage of estimated needs
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who completed head and neck cancer surgery and got a feeding tube perioperatively * Patients of legal age * Patients who can understand and read Scandinavian languages
Exclusion criteria
* Patients with allergy to components in parenteral nutrition * Patients where it is impossible to give parenteral nutrition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Infectious Complications | At day 30 | Local and systemic |
| Postoperative Thrombotic Complications | At day 30 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 2,3,4 | Data are collected from the patient's record. |
| Fistula formation without infection defined by journal documentation | Day 1,2,3,4,7,14, 23 and 30 | The measurement that will be used is documented fistula formation in the patients´ journal without increased infection parameters (c-reactive protein and leukocytes) |
| 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. | Day 2,3,4 | Data will be collected from the patient's record. |
| 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 | — |
Other
| Measure | Time frame |
|---|---|
| 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 |
| Presence of nausea under treatment measured by a VAS-scale (visual analogue scale). | Day 2,3,4 |
| 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. | Baseline and Day 2,3,4 |
Countries
Denmark
Outcome results
None listed