Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients

University of Copenhagen40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasm

Interventions

Parenteral NutritionOTHER

Supplementary parenteral nutrition to achieve 100% coverage of estimated needs

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinic for Ear, Nose and Throat Surgery, Rigshospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

Postoperative Infectious Complications

Local and systemic

Time frame: At day 30

Postoperative Thrombotic Complications

Time frame: At day 30

Secondary Outcomes

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)

Time frame: 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.

Data are collected from the patient's record.

Time frame: 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.

Time frame: Day 2,3,4

Length of stay at the hospital

Time frame: Up to 30 days

Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.

Time frame: Day 1,2,3,4

Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.

Data from ClinicalTrials.gov

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