Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Infectious complications
研究概览
简要总结
Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.
详细描述
Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •resectable GI cancer
- •written consent
排除标准
- •inoperable GI cancer
- •known allergy to the drug
研究组 & 干预措施
High Protein
Provision of 400 ml per day of high protein oral nutritional supplements
干预措施: resource protein (Drug)
Immuno ONS
Provision of 400 ml per day of immunostimulating oral nutritional supplements
干预措施: IMPACT (Drug)
结局指标
主要结局
Infectious complications
时间窗: 6 months
Number and type of infectious complications
次要结局
- Surgical complications(6 months)
- Length of stay(14 days)
研究者
Stanislaw Klek
Head of the Unit
Stanley Dudrick's Memorial Hospital