NCT00503334已完成不适用
Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery
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
- 36
- 试验地点
- 1
- 主要终点
- laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;
研究概览
简要总结
The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective pancreaticoduodenectomy
排除标准
- •Concomitant chemotherapy
- •Severe malnutrition (SGA score C)
- •Conditions affecting gastric emptying
研究组 & 干预措施
preOP booster
Experimental
干预措施: preOP booster (oral nutritional supplement, food for special medical purposes) (Dietary Supplement)
preOP booster placebo
Placebo Comparator
干预措施: preOP booster (oral nutritional supplement, food for special medical purposes) (Dietary Supplement)
结局指标
主要结局
laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;
时间窗: up to 30 days after surgery
次要结局
- postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance(up to 30 days after surgery)
研究者
研究点 (1)
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