NCT01421680已完成不适用
A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Postoperative complication rate
研究概览
简要总结
The objective of this study is to evaluate the effect of a perioperative nutrition strategy using oral nutritional supplements (ONS) on postoperative complications and improvement in body weight in malnourished patients who underwent gastrectomy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 20 years
- •Patients who undergo distal, total, proximal, or pylorus-preserving gastrectomy
- •Patients who are assessed as moderate or severe malnourished according to PG-SGA or patients with BMI lower than 18.5 kg/m2
- •Patients who can take oral meals
- •Patients who agree on the informed consent
排除标准
- •Emergent operation
- •Patients who received preoperative chemotherapy or radiation therapy within 6 months
- •Pregnant patients
- •Patients who cannot consume the Ensure powder
- •Patients who enrolled another clinical trials
结局指标
主要结局
Postoperative complication rate
时间窗: 7weeks
次要结局
- Body weight(7weeks)
- Body composition indices(7weeks)
- Length of hospital stay(7weeks)
- Quality of life(7weeks)
- Postoperative 30-day mortality(7weeks)
- Biochemical assessment of nutritional status(7weeks)
- Readmission rate(7weeks)
- Patient compliance of oral nutritional supplements(7weeks)
研究者
Han-Kwang Yang
Professor
Seoul National University Hospital
研究点 (2)
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