NCT03043183Unknown不适用
The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,400
- 主要终点
- complication
研究概览
简要总结
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.The perioperation nutritional status will be assessed in gastric cancer patients within ERAS protocols.The ERAS patients were randomly divided into perioperational nutrition support group and conventional pathway group . Inter-group differences were evaluated for nutritional index,clinical recovery index, complications etc.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy;
- •age 18-75 years;
- •pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy;
- •normal hematological, renal, hepatic, and cardiac parameters,American Society of Anesthesiology (ASA) score < III without severe systemic disease;
- •no history of treatment with neoadjuvant chemotherapy and/or radiotherapy
- •PG-SGA score ≥2，<9
排除标准
- •patients requiring conversion to open gastrectomy
- •excessive bleeding (˃ 500 mL);and patients opting out of the study.
结局指标
主要结局
complication
时间窗: 30 days after operation
fever；wound infection；post-operation bleeding；ileus；stenosis；leakage
次要结局
未报告次要终点
研究者
Quan Wang
Director
The First Hospital of Jilin University
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