Enhanced Recovery After Surgery Program for Gastric Cancer: a Multi-center Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 23
- 主要终点
- occurrence rate of severe complications
研究概览
简要总结
This study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.
详细描述
In China, gastric cancer results in the second highest morbidity and mortality rates among all malignancies. It is very important for treatment of gastric cancer to enhance the quality of treatment, increase patients' survival rate and improve the life quality. Now, "Gastric Cancer, Version 3.2016, NCCN Clinical Practice Guidelines in Oncology" and "Japanese gastric cancer treatment guidelines 2014 (ver. 4)" recommended surgical resection for gastric cancer. As a result, increasing the quality of surgery and improving the perioperative measures have a great influence on patients received a gastrectomy. Before, patients discharged on 7-10 days after gastrectomy and recovered 4-8 weeks after surgery. So, it is significant for patients to recover from surgical trauma in order to receive other anti-cancer therapies after gastrectomy. Investigators spent over ten years studying enhanced recovery after surgery programs for gastric cancer and have got some successful experience. Investigators found enhanced recovery after surgery can accelerate patients' recovery without increasing complications.
This study is the first multi-center study of enhanced recovery after surgery for gastric cancer all over the world. During this period, the study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- •Patients with gastric cancer scheduled for radical gastrectomy and between the age of 18 and 75 years old without considering sex
- •ASA physical status I-III
- •Participants can follow the drug doses and visit plan
排除标准
- •Patients certified by a doctor that doesn't fit to participate in this study.
- •Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received CABG recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
- •Patients with gastric cancer with distant metastasis.
- •Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
- •Patients allergic to common drugs, such as opioids, non-steroidal drugs, cephalosporins, etc.
- •Patients with operations of gastrointestinal cancer and complicated abdominal operations.
- •Patients complicated by gastric cancer with complications such as hemorrhage, perforation, obstruction.
- •Patients with dyscrasia and severe malnutrition (albumin≤30g/L, weight loss in half a year>10%, SGA classification C, BMI<18, Hb<70g/L).
- •Patients with metabolic complications caused by diabetes.
- •Patients can't finish enhanced recovery after surgery programs and have contraindications of enhanced recovery after surgery.
- •Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
- •Patients participated other subjects 3 months before this subject.
- •Sponsors or researchers directly involved in the testing or their family members.
研究组 & 干预措施
enhanced recovery after surgery
enhanced recovery after surgery includes:
- Multimodal analgesia
- Early oral intake A: Drink water after anesthetic awareness. B: Recover semi-liquid diet
- Management of nasogastric tube and catheter A: Not indwell nasogastric tube conventionally B: Remove catheter early
- Early activity
- Perioperative controlled infusion A: Load carbohydrate preoperatively B: No preoperative bowel preparation C: Fast six hours before surgery, no drink two hours before surgery D: Intraoperative liquid management: 3-6ml/kg/h, determined by anesthetists E: Stop intravenous infusion upon 2000-2500ml water and semiliquid diet being taken
干预措施: enhanced recovery after surgery (Procedure)
结局指标
主要结局
occurrence rate of severe complications
时间窗: 1 month
including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation
次要结局
- Actual postoperative length of hospital stay(1 month)
- Blood loss(1 day)
- Time to first flatus(2 week)
- Time to first defecation(2 week)
- Time of off-bed activity per day(1 week)
- CD4+/CD8+(1 week)
- Time to first semi-liquid diet(2 week)
- Distance of off-bed activity per day(1 week)
- Postoperative pain(1 week)
- Management of catheters(1 month)
- Preoperative length of hospital stay(1 month)
- Transferrin(1 week)
- HCT(1 week)
- Blood glucose(1 week)
- Hospital cost(1 month)
- CD3+(1 week)
- CD4+(1 week)
- Hb(1 week)
- WBC(1 week)
- Procalcitonin(1 week)
- Occurrence rate of ordinary complications(1 month)
- Intraoperative infusion(1 day)
- Time to first off-bed activity(1 week)
- Number of dissected lymph node(1 week)
- Readmission rate within 30 days after discharge(1 month)
- TNM classification(1 week)
- Ideal postoperative length of hospital stay(1 month)
- Operative time(1 day)
- IL-6(1 week)
- CRP(1 week)
- Albumin(1 week)
- Prealbumin(1 week)
- PLT(1 week)
研究者
Jian ZHAO
Vice director of Research Institute of General Surgery
Jinling Hospital, China