Enhanced Recovery After Surgery Program for Gastric Cancer: a Multi-center Study

Study Overview
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Brief Summary
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This study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.

Detailed Description
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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.

Official Title
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Enhanced Recovery After Surgery Program for Gastric Cancer: a Multi-center Study

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: enhanced recovery after surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will receive enhanced recovery after surgery programs.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enhanced recovery after surgery<br>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 | Procedure: enhanced recovery after surgery<br>* Undergo an enhanced recovery after surgery program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence rate of severe complications | including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence rate of ordinary complications | Except severe complications, Clavien-Dindo classification ≥Ⅱ complications need not reoperation | 1 month | 
| Readmission rate within 30 days after discharge | Readmission rate within 30 days after discharge | 1 month | 
| Ideal postoperative length of hospital stay | reach discharge criteria | 1 month | 
| Actual postoperative length of hospital stay | Actual postoperative length of hospital stay | 1 month | 
| Operative time | Data of operation | 1 day | 
| Blood loss | Data of operation | 1 day | 
| Intraoperative infusion | Data of operation | 1 day | 
| TNM classification | Data of tumor | 1 week | 
| Number of dissected lymph node | Data of tumor | 1 week | 
| Time to first flatus | Bowel function recovery | 2 week | 
| Time to first defecation | Bowel function recovery | 2 week | 
| Time to first semi-liquid diet | Bowel function recovery | 2 week | 
| Time to first off-bed activity | Postoperative activity | 1 week | 
| Time of off-bed activity per day | Postoperative activity | 1 week | 
| Distance of off-bed activity per day | Postoperative activity | 1 week | 
| Postoperative pain | VAS classification | 1 week | 
| Hospital cost | Hospital cost | 1 month | 
| Management of catheters | including nasogastric tube, catheter, intraperitoneal drain, infusion tube | 1 month | 
| Preoperative length of hospital stay | Preoperative length of hospital stay | 1 month | 
| CD3+ | Immune indicators | 1 week | 
| CD4+ | Immune indicators | 1 week | 
| CD4+/CD8+ | Immune indicators | 1 week | 
| IL-6 | Inflammatory indicators | 1 week | 
| CRP | Inflammatory indicators | 1 week | 
| Albumin | Nutritional indicators | 1 week | 
| Prealbumin | Nutritional indicators | 1 week | 
| Transferrin | Nutritional indicators | 1 week | 
| Hb | Nutritional indicators | 1 week | 
| WBC | Nutritional indicators | 1 week | 
| PLT | Nutritional indicators | 1 week | 
| HCT | Nutritional indicators | 1 week | 
| Blood glucose | Nutritional indicators | 1 week | 
| Procalcitonin | Infectious indicator | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enhanced recovery after surgery, gastric cancer