Enhanced Recovery After Surgery Program for Colorectal Cancer: a Multi-center Study (ERASC1)
NCT ID: NCT03126058
Last Updated: 2018-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2017-06-21
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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enhanced recovery after surgery
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
enhanced recovery after surgery
Patients will undergo enhanced recovery after surgery programs.
Interventions
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enhanced recovery after surgery
Patients will undergo enhanced recovery after surgery programs.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Jinling Hospital, China
OTHER
Responsible Party
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Jian ZHAO
Vice director of Research Institute of General Surgery
Principal Investigators
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Zhi-Wei JIANG
Role: PRINCIPAL_INVESTIGATOR
Jinling Hospital, Medical School of Nanjing University
Jian ZHAO
Role: STUDY_DIRECTOR
Jinling Hospital, Medical School of Nanjing University
Gang WANG
Role: STUDY_DIRECTOR
Jinling Hospital, Medical School of Nanjing University
Jiang LIU
Role: STUDY_DIRECTOR
Jinling Hospital, Medical School of Nanjing University
Locations
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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
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First People's Hospital of Taicang
Suzhou, Jiangsu, China
The Second People's Hospital of Changshu City
Suzhou, Jiangsu, China
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, China
The Taizhou People's Hospital
Taizhou, Jiangsu, China
The 101 Hospital of the Chinese People's Liberation Army
Wuxi, Jiangsu, China
Affiliated Hospital of Jiangnan University, The Forth People's Hospital of Wuxi
Wuxi, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Affiliated People's Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Qicheng LU, M.D.
Role: primary
Liming TANG, M.D.
Role: primary
Huiyu CHEN, M.D.
Role: primary
Zengtao BAO, M.D.
Role: backup
Yongchang MIAO, M.D.
Role: primary
Gang WANG
Role: backup
Hongyong CAO, M.D.
Role: primary
Zhi-Wei JIANG, Ph.D.
Role: primary
Jian ZHAO, Ph.D.
Role: backup
Jingmin WANG, M.D.
Role: primary
Jianping ZHANG, M.D.
Role: primary
Qinghong ZHAO, M.D.
Role: backup
Lizong SHEN, M.D.
Role: primary
Yongbin DING, M.D.
Role: backup
Jianqiang WU, M.D.
Role: primary
Xinhua GU, M.D.
Role: primary
Renbin SHEN
Role: backup
Haorong WU, M.D.
Role: primary
Yongyou WU, M.D.
Role: backup
Xinguo ZHU, M.D.
Role: primary
Zhongqi MAO
Role: backup
Yi WANG, M.D.
Role: primary
Bing WANG, M.D.
Role: backup
Guoqiang ZHOU, M.D.
Role: primary
Shusheng WANG, M.D.
Role: primary
Qinghong LIU, M.D.
Role: primary
Honggang WANG, M.D.
Role: backup
Guozhong WU, M.D.
Role: primary
Bojian FEI, M.D.
Role: primary
Xiaopeng LV, M.D.
Role: primary
Ping CHEN, M.D.
Role: primary
Xinxin LIU, M.D.
Role: backup
Jixiang CHEN, M.D.
Role: primary
Pengcheng JIANG, M.D.
Role: primary
Shouliang ZHANG, M.D.
Role: backup
Other Identifiers
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BE2015687C
Identifier Type: -
Identifier Source: org_study_id