NCT00730808已完成不适用
Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Immunoinflammatory parameters
研究概览
简要总结
The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (APR)
- •preoperative radiotherapy (5x5 Gy) or chemoradiation
- •loop ileostoma or colostoma;
排除标准
- •severe malnutrition
- •severe renal insufficiency
- •diabetes mellitus I or II
- •concomitant thyroid medication
- •corticosteroids
- •diuretic medication and antihypertensive medication
- •known or suspected allergy to any component of the investigational product(s)
结局指标
主要结局
Immunoinflammatory parameters
时间窗: on day -2, -1, 1, 2, 3, 5, and 7
Ischemia / reperfusion injury parameters
时间窗: on day -2, 1, 3, 5, and 7
Antioxidant / oxidant parameters
时间窗: on day -2, 1, 3, 5, and 7
次要结局
- hand grip strength(on day -2, 1, 2, 3, 5, and 7)
- Safety(on day -1, 0, 1, 2, 3, 5, and 7)
- GI tolerance(on day -1, 0, 1, 2, and 7)
- pre-and postoperative discomfort (well-being)(on day -1, and 0)
研究者
研究点 (1)
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