Enhanced Recovery After Surgery Programs for Patients Received Neoadjuvant Chemotherapy With Locally Advanced Gastric Cancer: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Postoperative length of stay
研究概览
简要总结
Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.
详细描述
Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing postoperative complications. However, in most trials, patients who received neoadjuvant chemotherapy were excluded. The investigators designed this trial for patients received neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled into the ERAS programs for locally advanced gastric cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients received neoadjuvant chemotherapy with locally advanced gastric cancer.
- •Age older than 18 and younger than 75 years.
- •American Society of Anesthesiologists (ASA) class: I-III.
- •Participants can describe the symptom objectively and cooperate actively.
- •Written informed consent.
排除标准
- •Patients allergic to oxaliplatin, tegafur gimerac etc.
- •Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA)
- •Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
- •Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min).
- •Patients who require simultaneous surgery for other diseases.
- •Patients who received upper abdominal surgery previously.
- •Pregnant or breast-feeding women.
研究组 & 干预措施
ERAS group
Patients will undergo the ERAS programs.
干预措施: ERAS group (Procedure)
SC group
Patients will undergo the SC group.
干预措施: SC group (Procedure)
结局指标
主要结局
Postoperative length of stay
时间窗: 1 month
Postoperative length of stay
次要结局
- Postoperative complications(2 months)
- The time to first flatus(1 week)
- Time to semi-liquid diet(2 week)
研究者
JIANG Zhi-Wei
Vice director of Research Institute of General Surgery
Jinling Hospital, China