Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy
Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial
研究概览
详细说明
Preoperative education about ERAS program is administered in the ward after admission by a specific team. Breathing training and atomizing during the time of preoperative preparation is performed during hospitalization (5-7 days). Patients are allowed to eat a normal diet and intake of 1000 ml 10% carbohydrate drink 10 hours before surgery and oral 500ml 10% carbohydrate drink 2 hours before the induction of anesthesia. Mechanical bowel preparation is not recommended as routine procedure.
The intravenous fluid therapy is restricted. Urinary catheters are routinely placed after anesthesia. In principle, drainage and nasogastric tube are not placed (except the concerns of surgical safety). Surgical site infiltration is implemented.All patients undergo laparoscopic distal gastrectomy.
Urinary catheters are routinely removed within 24 hours after operation. An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia. Adjunctive analgesia with acetaminophen is used after the resumption of oral intake until adequate pain relief. Patients were encouraged to move from POD 1. The patients are encouraged to a full fluid diet on POD 2. Adhere to the premise of eating little and often daily increase, then to semi-fluids to soft diet. A normal diet is often started on POD 4. Abdominal drains are routinely removed within 72 hours after operation.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510-515
- 招聘中
- Nanfang Hospital, Southern Medical University
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接触:
- Yu Zhu, M.D.
- 电话号码:+86-135-6022-0055
- 邮箱:283934099@qq.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
- Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
- no severe organ dysfunction
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) score class I or II
- Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of predicted values
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:ERAS
Preoperative education,breathing training and atomizing during the time of preoperative preparation.Shorten fasting time and carbohydrate load.The intravenous fluid therapy is restricted.Drainage and nasogastric tube are not placed (except the concerns of surgical safety).All patients undergo laparoscopic distal gastrectomy.An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia.Early oral take and move.
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Undergo an ERAS program
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Postoperative hospital stays
大体时间:1 month
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Days from surgery to discharge
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1 month
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Rehabilitative rate
大体时间:4 days
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Postoperative 4 days
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4 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Medical cost
大体时间:1 month
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From surgery to discharge
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1 month
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Postoperative pain score
大体时间:4 days
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Postoperative 4 days
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4 days
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Postoperative recovery index
大体时间:1 month
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1 month
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Postoperative inflammatory immune response
大体时间:4 days
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Postoperative 4 days
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4 days
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Morbidity rates
大体时间:30 days
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30 days
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Mortality rates
大体时间:30 days
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30 days
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合作者和调查者
调查人员
- 首席研究员:Guoxin Li, MD.,Ph.D、Southern Medical University, Guangzhou,China
- 首席研究员:Kexuan Liu, MD.,Ph.D、Southern Medical University, Guangzhou,China
- 研究主任:Hao Liu, MD.,Ph.D、Southern Medical University, Guangzhou,China
- 研究主任:Li Zhen, MD.,Ph.D、Southern Medical University, Guangzhou,China
- 研究主任:Xiaomin Hou, MD.,Ph.D、Southern Medical University, Guangzhou,China
- 研究主任:Jiang Yu, MD.,Ph.D、Southern Medical University, Guangzhou,China
- 研究主任:Yu Zhu, MD.、MD.,Ph.D
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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ERAS的临床试验
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Kocaeli Derince Education and Research HospitalKocaeli University未知