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

  • STATUS
    Recruiting
  • participants needed
    1000
  • sponsor
    Jinling Hospital, China
Updated on 8 November 2020
Investigator
Ping CHEN, M.D.
Primary Contact
Northern Jiangsu People's Hospital (2.0 mi away) Contact
+14 other location

Summary

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

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.

Details
Treatment enhanced recovery after surgery
Clinical Study IdentifierNCT03126058
SponsorJinling Hospital, China
Last Modified on8 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Colorectal Cancer?
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

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 pressure180mmHg or diastolic pressure110mmHg)
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 (albumin30g/L, weight loss in half a year10%, SGA classification C, BMI18, Hb70g/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
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