Impact of Preoperative Oral Diets on Postoperative Fluid Collection After Axillary Lymphadenectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Fluid collection
研究概览
简要总结
Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.
详细描述
Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections, which requires either prolonged drainage or multiple punctuations. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The physician is unaware of the type of the intervention. The type of intervention is given by the independent person to dietitian instructing the patient how to use the product.
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
- •confirmed breast cancer or melanoma
- •scheduled surgery with axillary lymph nodes resection
- •informed consent
- •eligible for surgery
排除标准
- •benign disease
- •no consent
研究组 & 干预措施
Immunonutrition
Oral immunonutrition containing arginine, omega-PUFAs and antioxidants
干预措施: Immunonutrition (Dietary Supplement)
High-protein diet
Oral nutrition with high-protein content
干预措施: High-protein nutrition (Dietary Supplement)
Standard nutrition
Oral nutrition with standard ingredients
干预措施: Standard nutrition (Dietary Supplement)
No intervention
No intervention
结局指标
主要结局
Fluid collection
时间窗: 6 months
The volume of fluid collection after lymph nodes resection expressed in mililiters
次要结局
未报告次要终点
研究者
Stanislaw Klek
Head of the Unit
Stanley Dudrick's Memorial Hospital