A Pilot Study Investigating the Effect of Post-operative Home Jejunostomy Feeding on Quality of Life and Nutritional Parameters in Patients With Oesophago-gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Participant recruitment and retention rates
研究概览
简要总结
After surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely fed by means of a small feeding tube into the intestine (jejunostomy, JEJ) while they are in hospital. Current practice is to stop feeding once the patient leaves hospital, although the tube is left in place for the first 6 weeks. Most patients lose weight after surgery and have to learn to adjust to new eating habits and behaviours. A few patients have the JEJ feed restarted because of nutritional problems and this requires a further inpatient stay.
It is unknown whether every patient would benefit from this type of feeding at home. Previous studies have only assessed the value of JEJ feeding while patients are still in hospital. There is little known about the benefit of continuing JEJ feeding after discharge from hospital, although home feeding is not uncommon in other patient groups (eg. after a stroke).
The proposed study will provide initial information on patients' well being by measuring quality of life and factors such as change in body weight and dietary intake following a period of home JEJ feeding after surgery. Subjects recruited into the study will be placed, randomly, into a control group who receive current nutritional care (based on dietary advice and oral nutritional supplement drinks) or an intervention group who will receive home JEJ feeding for 6 weeks after hospital discharge, in addition to current treatment.
If subjects in the control group are experiencing problems eating at home, home feeding through the JEJ tube will be started as needed.
The study will also examine how surgery and JEJ feeding at home impact on the patient and carer(s) by means of questionnaires and interviews conducted in the patients' home.
Information obtained will assist in the design of a multicentre study. This intervention is considered important because it has the potential to benefit thousands of patients each year at a modest cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •planned esophagectomy or total gastrectomy for adenocarcinoma or squamous carcinoma
- •suitable for home enteral nutrition
排除标准
- •inability to provide written informed consent
结局指标
主要结局
Participant recruitment and retention rates
时间窗: 7 months
This pilot study will inform the design and planning of a larger multi-centre study
次要结局
- Qualitative analysis(8 weeks)
- Quality of life(Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery)
- Readmission rates(7 months)
- Health economics(7 months)
- Food intake(Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery)
- Nutritional parameters(Recruitment, 3 wks, 6 wks, 3 months, 6 months after surgery)
