Enhanced Recovery After Surgery Program for Colorectal Cancer: a Multi-center Study (ERASC1)
- Conditions
- Colorectal Cancer
- Registration Number
- NCT03126058
- Lead Sponsor
- Jinling Hospital, China
- Brief Summary
This study is aimed to evaluate the safety of applying enhanced recovery after surgery for colorectal cancer.
- Detailed Description
In China, Europe and America, colorectal cancer is one of common malignant tumors. It is very important for treatment of colorectal cancer to enhance the quality of treatment, increase patients' survival rate and improve the life quality. So far, surgical resection is optimal treatment for patients with colorectal cancer. As a result, increasing the quality of surgery and improving the perioperative managements have a great influence on patients received a coloproctectomy. Investigators have spent over ten years studying enhanced recovery after surgery programs for colorectal 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 colorectal cancer in China. During this period, the study is aimed to evaluate the safety of applying enhanced recovery after surgery for colorectal 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 colorectal cancer scheduled for radical coloproctectomy 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 colorectal 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 colorectal 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
- 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 Operative time 1 day duration of operation
Occurrence rate of ordinary complications 1 month Except severe complications, Clavien-Dindo classification ≥Ⅱ complications need not reoperation
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
TNM classification 1 week classification of tumor
Time to first flatus 2 week Bowel function recovery
Time to first defecation 2 week Bowel function recovery
Number of dissected lymph node 1 week Number of dissected lymph node
Distance of off-bed activity per day 1 week Postoperative activity
Time to first semi-liquid diet 2 week Bowel function recovery
Time to first off-bed activity 1 week Postoperative activity
Postoperative pain 1 week VAS classification
Time of off-bed activity per day 1 week Postoperative activity
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
CD3+ 1 week Immune indicators
IL-6 1 week Inflammatory 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
Procalcitonin 1 week Infectious indicator
CD4+ 1 week Immune indicators
CRP 1 week Inflammatory indicators
Albumin 1 week Nutritional indicators
HCT 1 week Nutritional indicators
Blood loss 1 day Blood loss
Intraoperative infusion 1 day Intraoperative infusion
Hospital cost 1 month Hospital cost
CD4+/CD8+ 1 week Immune indicators
Blood glucose 1 week Nutritional indicators
Trial Locations
- Locations (23)
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
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Jinling Hospital, Medical School of Nanjing University
🇨🇳Nanjing, Jiangsu, China
Zhongda Hospital, Southeast University
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Suqian People's Hospital, Nanjing Drum Tower Hospital
🇨🇳Suqian, Jiangsu, China
Scroll for more (13 remaining)The First People's Hospital of Changzhou🇨🇳Changzhou, Jiangsu, ChinaQicheng LU, M.D.Principal Investigator