NCT01645852已完成不适用
A Randomized Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 6
- 主要终点
- The effect of a low calorie diet on intra-operative blood loss, technical ease of hepatic transection, complication rates (including infectious complications), length of stay and mortality in patients undergoing liver surgery.
研究概览
简要总结
The purpose of this study is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.
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
- Single (Investigator)
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
- •Age 18 or greater
- •Clinical indication for a therapeutic liver resection
- •BMI of 25 kg/m2 or greater
- •Informed Consent
排除标准
- •Inability to comply with the pre-op diet
- •Patients who have lost 5% or more of their usual body weight over the preceding one month
- •Female patients of childbearing age who have a positive pregnancy test
结局指标
主要结局
The effect of a low calorie diet on intra-operative blood loss, technical ease of hepatic transection, complication rates (including infectious complications), length of stay and mortality in patients undergoing liver surgery.
时间窗: 30 days post-operatively
Intra-operative blood loss will be strictly quantified. Units of autologous or donor blood transfused will be recorded. The surgeon will assess the ease of liver mobilization and parenchymal transection using a 1-5 scale where 1 is easy and 5 is hard. Post-operative complications, length of stay and mortality will be recorded.
次要结局
- The effect of a low calorie diet on steatosis and steatohepatitis.(30 days post-operatively)
- The mechanism of decreased steatosis in patients undergoing a low-calorie pre-op diet by measuring levels of expression of molecules involved in the de novo synthesis, hepatic uptake and degradation of lipids.(30 days post-operatively)
研究者
研究点 (6)
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