Randomised Trial of Enteral Feeding in Patients Discharged From Hospital Following Surgical Resection of an Upper Gastrointestinal Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Fatigue
研究概览
简要总结
Patients due to undergo surgery for oesophageal and gastric malignancy are often malnourished. Up to 10% of patients preoperative weight may also be lost during the early postoperative period. Following discharge from hospital the mechanics of the surgery leads to a loss of gastric reservoir function, lack of appetite, altered intestinal motility and gastro-oesophageal reflux which usually results in reduced dietary intake and further weight loss. In patients who have undergone upper gastrointestinal resections there are no studies examining the benefit of nutritional supplementation following hospital discharge, however, studies in other groups of surgical patients have failed to show benefit. Despite patients who have undergone upper gastrointestinal surgery being 'at risk' nutritionally, there is no evidence demonstrating the value or not of nutritional supplementation following hospital discharge.
Hypothesis: The postoperative under nutrition seen after upper gastrointestinal surgery will exacerbate the reduced quality of life and fatigue patients' already experience. The investigators hypothesise that improving patient's nutritional intake following hospital discharge will improve their quality of life and fatigue levels.
详细描述
For patients undergoing upper gastrointestinal (GI) surgery for cancer:
- Because of the nature of upper gastrointestinal surgery these patients have been shown to suffer undernutrition and weight loss after hospital discharge (up to 3 months) and to a greater extent than other groups of surgical patients. Quality of life and fatigue is a major issue after upper GI surgery.
- Nutritional supplementation via a jejunostomy after hospital discharge is only done routinely for all patients in 10%, and for selected patients in 20% of United Kingdom (UK) hospitals.
- Derriford hospital is very unusual in that 85% of patients are given home jejunal feeding.
- In Devon and Cornwall home enteral nutrition is delivered under contract by Fresenius Kabil (a global health care company).
- There are no studies of home nutritional supplementation in upper GI surgical patients.
- Studies of home nutritional supplementation in surgical patients having undergone colorectal surgery have not shown clinical or Quality of Life (QoL) benefit despite weight gain.
- The process of enteral nutrition may be associated with a reduction in quality of life.
- There is a need for a clinical trial to establish the benefit of home enteral nutritional supplementation. The results of any such trial may influence the highly variable nutritional present practice and may influence the surgeons desire to place a feeding jejunostomy (or not) at surgery which is associated with clinical complications.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients able to give written informed consent,
- •Have had a feeding jejunostomy placed at surgery,
- •Competent (or their carer) to set up and use the jejunostomy feeding apparatus themselves.
排除标准
- •Participating in another interventional trial,
- •Age <18,
- •Pre-operative BMI > 35,
- •Pre-operative BMI <18,
- •Oral intake at hospital discharge of > 90% of requirements,
- •It is felt that they or their carers would not to cope with home tube feeding Patients unable to give written informed consent.
结局指标
主要结局
Fatigue
时间窗: 18 weeks
The primary outcome will therefore be fatigue as measured by the multidimensional fatigue inventory (MFI-20) score. The MFI-20 is divided into five scales: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue.
次要结局
- Quality of life(18 weeks)
- Health economic analysis(18 weeks)