Enhanced Recovery After Surgery Program for Colorectal Cancer: a Multi-center Study (ERASC1)

Jinling Hospital, China

Status: Unknown

Conditions: Colorectal Cancer

Treatments: Procedure: enhanced recovery after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03126058

BE2015687C

Details and patient eligibility

About

This study is aimed to evaluate the safety of applying enhanced recovery after surgery for colorectal cancer.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable
2. Patients with colorectal cancer scheduled for radical coloproctectomy 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 colorectal 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 colorectal 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

enhanced recovery after surgery

Experimental group

Description:

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 for right hemicolectomy, Miles rectectomy and Hartman rectectomy, simple cleansing enema for left hemicolectomy,sigmoidectomy and Dixon rectectomy; 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

Treatment:

Procedure: enhanced recovery after surgery