Enhanced Recovery After Surgery Program for Gastric Cancer: a Multi-center Study
- Conditions
- Gastric Cancer
- Interventions
- Procedure: enhanced recovery after surgery
- Registration Number
- NCT03121729
- Lead Sponsor
- Jinling Hospital, China
- Brief Summary
This study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description enhanced recovery after surgery enhanced recovery after surgery enhanced recovery after surgery includes: 1. Multimodal analgesia 2. Early oral intake A: Drink water after anesthetic awareness. B: Recover semi-liquid diet 3. Management of nasogastric tube and catheter A: Not indwell nasogastric tube conventionally B: Remove catheter early 4. Early activity 5. 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
- Primary Outcome Measures
Name Time Method occurrence rate of severe complications 1 month including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation
- Secondary Outcome Measures
Name Time Method Blood loss 1 day Data of operation
Actual postoperative length of hospital stay 1 month Actual postoperative length of hospital stay
Time to first flatus 2 week Bowel function recovery
Time to first defecation 2 week Bowel function recovery
Time of off-bed activity per day 1 week Postoperative activity
CD4+/CD8+ 1 week Immune indicators
Transferrin 1 week Nutritional indicators
HCT 1 week Nutritional indicators
Blood glucose 1 week Nutritional indicators
Time to first semi-liquid diet 2 week Bowel function recovery
Distance of off-bed activity per day 1 week Postoperative activity
Postoperative pain 1 week VAS classification
Management of catheters 1 month including nasogastric tube, catheter, intraperitoneal drain, infusion tube
Preoperative length of hospital stay 1 month Preoperative length of hospital stay
Hospital cost 1 month Hospital cost
CD3+ 1 week Immune indicators
CD4+ 1 week Immune indicators
Hb 1 week Nutritional indicators
WBC 1 week Nutritional indicators
Procalcitonin 1 week Infectious indicator
Occurrence rate of ordinary complications 1 month Except severe complications, Clavien-Dindo classification ≥Ⅱ complications need not reoperation
Intraoperative infusion 1 day Data of operation
Time to first off-bed activity 1 week Postoperative activity
Readmission rate within 30 days after discharge 1 month Readmission rate within 30 days after discharge
TNM classification 1 week Data of tumor
Number of dissected lymph node 1 week Data of tumor
Ideal postoperative length of hospital stay 1 month reach discharge criteria
Operative time 1 day Data of operation
IL-6 1 week Inflammatory indicators
CRP 1 week Inflammatory indicators
Albumin 1 week Nutritional indicators
Prealbumin 1 week Nutritional indicators
PLT 1 week Nutritional indicators
Trial Locations
- Locations (23)
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Changzhou Second People's Hospital Affiliated to Nanjing Medical University
🇨🇳Changzhou, Jiangsu, China
The First People's Hospital of Lianyungang City
🇨🇳Lianyungang, Jiangsu, China
The Second People's Hospital of Lianyungang City
🇨🇳Lianyungang, Jiangsu, China
Affiliated Hospital of Jiangnan University, The Forth People's Hospital of Wuxi City
🇨🇳Wuxi, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Zhongda Hospital, Southeast University
🇨🇳Nanjing, Jiangsu, China
Jinling Hospital, Medical School of Nanjing University
🇨🇳Nanjing, Jiangsu, China
the Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Suqian People's Hospital, Nanjing Drum Tower Hospital
🇨🇳Suqian, Jiangsu, China
the First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First People's Hospital of Taicang
🇨🇳Suzhou, Jiangsu, China
Zhangjiagang First People's Hospital
🇨🇳Suzhou, Jiangsu, China
the Taizhou People's Hospital
🇨🇳Taizhou, Jiangsu, China
The 101 Hospital of the Chinese People's Liberation Army
🇨🇳Wuxi, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Affiliated People's Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China