Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial
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
- 否
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.
研究组 & 干预措施
conventional pathway group
The conventional pathway group received conventional care.
ERAS group
Patients were admitted 1-3 days prior to their respective dates of operation. A ERAS protocol was used in the ERAS group.
干预措施: ERAS (Procedure)
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)