Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Rehabilitative rate
研究概览
简要总结
This study evaluates the safety and effectiveness of enhanced recovery after surgery(ERAS) on laparoscopic distal gastrectomy for gastric cancer.All of participants received an ERAS program.
详细描述
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
- •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
排除标准
- •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
结局指标
主要结局
Rehabilitative rate
时间窗: 4 days
Postoperative 4 days
Postoperative hospital stays
时间窗: 1 month
Days from surgery to discharge
次要结局
- Medical cost(1 month)
- Postoperative inflammatory immune response(4 days)
- Postoperative pain score(4 days)
- Postoperative recovery index(1 month)
- Mortality rates(30 days)
- Morbidity rates(30 days)
研究者
Guoxin Li
M.D.,Ph.D.
Nanfang Hospital, Southern Medical University