SpPN-HNC: Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention group Supplementary parenteral nutrition |
Other: Parenteral Nutrition
Supplementary parenteral nutrition to achieve 100% coverage of estimated needs
|
| No Intervention: Control group The control group will receive standard nutritional care |
Outcome Measures
Primary Outcome Measures
- Postoperative Infectious Complications [At day 30]
Local and systemic
- Postoperative Thrombotic Complications [At day 30]
Secondary Outcome Measures
- 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 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.
- 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 Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinic for Ear, Nose and Throat Surgery, Rigshospital | Copenhagen | Denmark | 2100 Cph OE |
Sponsors and Collaborators
- University of Copenhagen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-16042979