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临床试验/NCT03046303
NCT03046303Unknown不适用

Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial

The First Hospital of Jilin University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年2月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
clinical parameters

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.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.

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
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

入选标准

  • (1) 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; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score < III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy.

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

clinical parameters

时间窗: One week after operation

length of post-operative stay

次要结局

  • Postoperative complications(30 days after operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Radical Gastrectomy Within Enhanced Recovery... | 临床试验