NCT03042195已完成不适用
Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients - A Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative Infectious Complications
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with allergy to components in parenteral nutrition
- •Patients where it is impossible to give parenteral nutrition
研究组 & 干预措施
Intervention group
Active Comparator
Supplementary parenteral nutrition
干预措施: Parenteral Nutrition (Other)
Control group
No Intervention
The control group will receive standard nutritional care
结局指标
主要结局
Postoperative Infectious Complications
时间窗: At day 30
Local and systemic
Postoperative Thrombotic Complications
时间窗: At day 30
次要结局
- Fistula formation without infection defined by journal documentation(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.(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.(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)
研究者
Jens Rikardt Andersen
Associate Professor
University of Copenhagen
研究点 (1)
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