A Single Center, Open, Randomized Clinical Trial：Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Hospitalization Days
研究概览
简要总结
At present, there are more and more reports about enhanced recovery after surgery（ERAS）in China, but there is no ERAS treatment standard for gastrointestinal cancer, and there are many factors limiting the development of ERAS. In recent years, due to the development of minimally invasive technology, the establishment of evidence-based medicine model and the development of MDT, it makes a good solid foundation for the clinical application of ERAS. The implementation of ERAS requires the cooperation of surgeons, anesthesia management, nursing, rehabilitation and other teams. As an individualized treatment mode, ERAS focuses on the optimization of treatment for different individuals in order to acquire the best benefit of patients. Therefore, the concept of ERAS is still in the process of continuous improvement and development in China, hoping to explore the Chinese ERAS clinical pathway for gastrointestinal cancer. The purpose of this study is to optimize the clinical pathway of ERAS in the perioperative period of gastrointestinal cancer, and to evaluate the effectiveness and safety of ERAS in gastrointestinal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent
- •Preoperative pathology confirmed gastric cancer or colorectal cancer
- •Age: 18-70 years, men or women
- •According to NCCN guidelines, it is not Stage IV tumor
- •Perform radical gastrectomy or radical colon cancer surgery (CME) or radical rectal cancer surgery (TME);
- •ASA I-III
- •Receive no radiotherapy or chemotherapy before operation
- •The subjects can describe the symptoms objectively and keep the follow-up plan
排除标准
- •Preoperative pathology confirmed no gastric cancer / no colorectal cancer (such as rectal neuroendocrine tumor, lymphoma, etc.)
- •Stage IV or Radical resection can't be performed
- •Emergency operation
- •Can't cooperate with clinical data collection
- •General condition is intolerable to operation
- •Serious diseases, including heart function ≥ level II, respiratory function insufficiency, liver and kidney function insufficiency, and blood system diseases
- •Patients participate in other clinical trials at the same time
- •Pregnant or perinatal women
- •Other malignant tumors
- •History of mental illness
- •Had a history of severe trauma within 4 weeks before admission
- •Less than 6 months after other level 4 operations
结局指标
主要结局
Hospitalization Days
时间窗: Postoperative up to 2 weeks
The time to first flatus
时间窗: Postoperative 7 days
Time of getting out of bed after operation
时间窗: Postoperative 7 days
次要结局
- Expenses on medical treatment, medicine and hospitalization(On discharge, Postoperative up to 2 weeks)
- Incidence of postoperative complications(Postoperative 3 months、6 months、1 year)