Gastric Cancer
Conditions
Keywords
enhanced recovery after surgery, gastric cancer
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.
Interventions
PROCEDUREenhanced recovery after surgery
Undergo an enhanced recovery after surgery program
Sponsors
Jinling Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will receive enhanced recovery after surgery programs.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable 2. Patients with gastric cancer scheduled for radical gastrectomy and between the age of 18 and 75 years old without considering sex 3. ASA physical status I-III 4. Participants can follow the drug doses and visit plan
Exclusion criteria
1. Patients certified by a doctor that doesn't fit to participate in this study. 2. 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). 3. Patients with gastric cancer with distant metastasis. 4. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance \< 25 ml/min). 5. Patients allergic to common drugs, such as opioids, non-steroidal drugs, cephalosporins, etc. 6. Patients with operations of gastrointestinal cancer and complicated abdominal operations. 7. Patients complicated by gastric cancer with complications such as hemorrhage, perforation, obstruction. 8. Patients with dyscrasia and severe malnutrition (albumin≤30g/L, weight loss in half a year\>10%, SGA classification C, BMI\<18, Hb\<70g/L). 9. Patients with metabolic complications caused by diabetes. 10. Patients can't finish enhanced recovery after surgery programs and have contraindications of enhanced recovery after surgery. 11. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants). 12. Patients participated other subjects 3 months before this subject. 13. Sponsors or researchers directly involved in the testing or their family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence rate of severe complications | 1 month | including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmission rate within 30 days after discharge | 1 month | Readmission rate within 30 days after discharge |
| Ideal postoperative length of hospital stay | 1 month | reach discharge criteria |
| Actual postoperative length of hospital stay | 1 month | Actual postoperative length of hospital stay |
| Operative time | 1 day | Data of operation |
| Blood loss | 1 day | Data of operation |
| Intraoperative infusion | 1 day | Data of operation |
| TNM classification | 1 week | Data of tumor |
| Number of dissected lymph node | 1 week | Data of tumor |
| Time to first flatus | 2 week | Bowel function recovery |
| Time to first defecation | 2 week | Bowel function recovery |
| Time to first semi-liquid diet | 2 week | Bowel function recovery |
| Time to first off-bed activity | 1 week | Postoperative activity |
| Time of off-bed activity per day | 1 week | Postoperative activity |
| Distance of off-bed activity per day | 1 week | Postoperative activity |
| Postoperative pain | 1 week | VAS classification |
| Hospital cost | 1 month | Hospital cost |
| Occurrence rate of ordinary complications | 1 month | Except severe complications, Clavien-Dindo classification ≥Ⅱ complications need not reoperation |
| Preoperative length of hospital stay | 1 month | Preoperative length of hospital stay |
| CD3+ | 1 week | Immune indicators |
| CD4+ | 1 week | Immune indicators |
| CD4+/CD8+ | 1 week | Immune indicators |
| IL-6 | 1 week | Inflammatory indicators |
| CRP | 1 week | Inflammatory indicators |
| Albumin | 1 week | Nutritional indicators |
| Prealbumin | 1 week | Nutritional indicators |
| Transferrin | 1 week | Nutritional indicators |
| Hb | 1 week | Nutritional indicators |
| WBC | 1 week | Nutritional indicators |
| PLT | 1 week | Nutritional indicators |
| HCT | 1 week | Nutritional indicators |
| Blood glucose | 1 week | Nutritional indicators |
| Procalcitonin | 1 week | Infectious indicator |
| Management of catheters | 1 month | including nasogastric tube, catheter, intraperitoneal drain, infusion tube |
Countries
China
Contacts
Primary ContactZhi-Wei JIANG, Ph.D.
Backup ContactJian ZHAO, Ph.D.
Outcome results
None listed