NCT01361750终止不适用
The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy: A Randomized Control Trial and Physiological Study
Peking University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- change of nutritional status and quality of life before and after operation
研究概览
简要总结
This study is to investigate the effects of narrowed gastric tube on postoperative nutritional status and the quality of life in esophageal cancer patients treated with Ivor-Lewis esopagectomy in a 12-month follow-up period.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •esophageal cancer (squamous and adenocarcinoma subtypes)
- •eligble for Ivor-Lowis esophagectomy
- •expected survival time longer than 12 months
排除标准
- •palliative resection(non-R0)
- •anastomosis leak
- •jejunum or colon transversum interponate
研究组 & 干预措施
gastirc tube group
Experimental
conduit will be perfomed by narrowed gastric tube
干预措施: gastric tube (Procedure)
control group
No Intervention
conduit will be traditional subtotal stomach without any surgical modification
结局指标
主要结局
change of nutritional status and quality of life before and after operation
时间窗: before operation (baseline), 1 month, 6 month and 12 month after operation
次要结局
- change of serum markers and tissue inflammatory status before and after operation(before operation (baseline), 1 month, 6 month and 12 month after operation)
研究者
Yang Yue
Thoracic Surgery II
Peking University
研究点 (1)
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