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临床试验/NCT02031094
NCT02031094已完成不适用

The Effect of Liver Regeneration on Resting Energy Expenditure After Liver Resectional Surgery

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Change in Resting Energy Expenditure (Kcal) following liver resection

研究概览

简要总结

This observational study will measure resting energy expenditure in patients who have undergone liver resection and compare methods of measuring resting energy expenditure.

详细描述

Penetrating liver injury occurs commonly in victims of battlefield trauma. It is associated with a high mortality and morbidity rate. Management of liver injury is complex and challenging and can often involve debridement or anatomical resection of liver tissue.

Following liver resection, the liver regenerates to its original volume. Liver regeneration involves complex metabolic processes and maximal regeneration occurs over the first post operative week. This process is highly energy dependent and adds a further burden on post operative energy and therefore nutritional requirements.

Inadequate post-operative nutrition is associated with poorer outcomes and complication rates. Additionally, over feeding is also associated with adverse outcome. The actual additional energy expenditure involved in liver regeneration is not currently known and therefore accurate calorific balance remains a challenge.

The measurement of energy expenditure in these patients is therefore important. Traditionally energy expenditure has been measured by indirect calorimetry and doubly labelled water. These techniques require skilled operators and are often impractical for everyday clinical usage and impossible in the deployed setting.

A recent development is a lightweight armband that measures total and resting energy expenditure. It has been validated against the gold standard techniques in various settings including cancer cachexia, obesity and healthy volunteers and is deemed highly acceptable also. It has not been validated in the unique setting of liver regeneration.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing liver resection for benign or malignant hepatic neoplasm

排除标准

  • Inability to give written, informed consent.
  • Jaundice (Bilirubin > 100 μmol/L)
  • Liver resection combined with secondary surgical procedure.
  • Age < 18 years
  • Pregnant women
  • Unable to tolerate either measuring device

结局指标

主要结局

Change in Resting Energy Expenditure (Kcal) following liver resection

时间窗: 2 weeks pre-operatively and post-operative days 3,5 and 7

次要结局

  • Change in total energy expenditure (Kcal) following liver resection(2 weeks pre-operatively and post-operative days 3,5 and 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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