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

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ClinicalTrials.gov Identifier: NCT03126058
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Jian ZHAO, Jinling Hospital, China

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: enhanced recovery after surgery Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients will receive enhanced recovery after surgery programs.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhanced Recovery After Surgery Program for Colorectal Cancer: a Multi-center Study
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Procedure: enhanced recovery after surgery
Patients will undergo enhanced recovery after surgery programs.




Primary Outcome Measures :
  1. occurrence rate of severe complications [ Time Frame: 1 month ]
    including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation


Secondary Outcome Measures :
  1. Occurrence rate of ordinary complications [ Time Frame: 1 month ]
    Except severe complications, Clavien-Dindo classification ≥Ⅱ complications need not reoperation

  2. Readmission rate within 30 days after discharge [ Time Frame: 1 month ]
    Readmission rate within 30 days after discharge

  3. Ideal postoperative length of hospital stay [ Time Frame: 1 month ]
    reach discharge criteria

  4. Actual postoperative length of hospital stay [ Time Frame: 1 month ]
    Actual postoperative length of hospital stay

  5. Operative time [ Time Frame: 1 day ]
    duration of operation

  6. Blood loss [ Time Frame: 1 day ]
    Blood loss

  7. Intraoperative infusion [ Time Frame: 1 day ]
    Intraoperative infusion

  8. TNM classification [ Time Frame: 1 week ]
    classification of tumor

  9. Number of dissected lymph node [ Time Frame: 1 week ]
    Number of dissected lymph node

  10. Time to first flatus [ Time Frame: 2 week ]
    Bowel function recovery

  11. Time to first defecation [ Time Frame: 2 week ]
    Bowel function recovery

  12. Time to first semi-liquid diet [ Time Frame: 2 week ]
    Bowel function recovery

  13. Time to first off-bed activity [ Time Frame: 1 week ]
    Postoperative activity

  14. Time of off-bed activity per day [ Time Frame: 1 week ]
    Postoperative activity

  15. Distance of off-bed activity per day [ Time Frame: 1 week ]
    Postoperative activity

  16. Postoperative pain [ Time Frame: 1 week ]
    VAS classification

  17. Hospital cost [ Time Frame: 1 month ]
    Hospital cost

  18. Management of catheters [ Time Frame: 1 month ]
    including nasogastric tube, catheter, intraperitoneal drain, infusion tube

  19. Preoperative length of hospital stay [ Time Frame: 1 month ]
    Preoperative length of hospital stay

  20. CD3+ [ Time Frame: 1 week ]
    Immune indicators

  21. CD4+ [ Time Frame: 1 week ]
    Immune indicators

  22. CD4+/CD8+ [ Time Frame: 1 week ]
    Immune indicators

  23. IL-6 [ Time Frame: 1 week ]
    Inflammatory indicators

  24. CRP [ Time Frame: 1 week ]
    Inflammatory indicators

  25. Albumin [ Time Frame: 1 week ]
    Nutritional indicators

  26. Prealbumin [ Time Frame: 1 week ]
    Nutritional indicators

  27. Transferrin [ Time Frame: 1 week ]
    Nutritional indicators

  28. Hb [ Time Frame: 1 week ]
    Nutritional indicators

  29. WBC [ Time Frame: 1 week ]
    Nutritional indicators

  30. PLT [ Time Frame: 1 week ]
    Nutritional indicators

  31. HCT [ Time Frame: 1 week ]
    Nutritional indicators

  32. Blood glucose [ Time Frame: 1 week ]
    Nutritional indicators

  33. Procalcitonin [ Time Frame: 1 week ]
    Infectious indicator



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126058


Contacts
Contact: Zhi-Wei JIANG, Ph.D. 8602580860034 nzjiangzhiwei@163.com
Contact: Jian ZHAO, Ph.D. 8602580860034 zhaojiangogo@163.com

Locations
China, Jiangsu
The First People's Hospital of Changzhou Recruiting
Changzhou, Jiangsu, China, 213003
Contact: Qicheng LU, M.D.       changyiluqicheng@sina.com   
Principal Investigator: Qicheng LU, M.D.         
Changzhou Second People's Hospital Affiliated to Nanjing Medical University Recruiting
Changzhou, Jiangsu, China, 213164
Contact: Liming TANG, M.D.       drtanglm@gmail.com   
Principal Investigator: Liming TANG, M.D.         
The First People's Hospital of Lianyungang City Recruiting
Lianyungang, Jiangsu, China, 222002
Contact: Huiyu CHEN, M.D.         
Contact: Zengtao BAO, M.D.         
Principal Investigator: Huiyu CHEN, M.D.         
The Second People's Hospital of Lianyungang City Recruiting
Lianyungang, Jiangsu, China, 222006
Contact: Yongchang MIAO, M.D.       lygmiao@sina.com   
Contact: Gang WANG    M.D.      
Principal Investigator: Yongchang MIAO, M.D.         
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Hongyong CAO, M.D.       caohongy6167@163.com   
Principal Investigator: Hongyong CAO, M.D.         
Jinling Hospital, Medical School of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Zhi-Wei JIANG, Ph.D.    8602580860034    nzjiangzhiwei@163.com   
Contact: Jian ZHAO, Ph.D.    8602580860034    zhaojiangogo@163.com   
Principal Investigator: Zhi-Wei JIANG, Ph.D.         
Sub-Investigator: Gang WANG, Ph.D.         
Sub-Investigator: Jian ZHAO, Ph.D.         
Sub-Investigator: Jiang LIU, M.D.         
Zhongda Hospital, Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Jingmin WANG, M.D.       wjm730222@163.com   
Principal Investigator: Jingmin WANG, M.D.         
The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Jianping ZHANG, M.D.       zhang_jp64@aliyun.com   
Contact: Qinghong ZHAO, M.D.       njzhqh@sina.com   
Principal Investigator: Jianping ZHANG, M.D.         
Principal Investigator: Qinghong ZHAO, M.D.         
The First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Lizong SHEN, M.D.       shenlz@njmu.edu.cn   
Contact: Yongbin DING, M.D.         
Principal Investigator: Lizong SHEN, M.D.         
Suqian People's Hospital, Nanjing Drum Tower Hospital Recruiting
Suqian, Jiangsu, China, 223800
Contact: Jianqiang WU, M.D.       wjq-10@163.com   
Principal Investigator: Jianqiang WU, M.D.         
Suzhou Municipal Hospital Recruiting
Suzhou, Jiangsu, China, 215000
Contact: Xinhua GU, M.D.         
Contact: Renbin SHEN    M.D.      
Principal Investigator: Xinhua GU, M.D.         
The Second Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215004
Contact: Haorong WU, M.D.       wuhaorong666@126.com   
Contact: Yongyou WU, M.D.       13338706607@126.com   
Principal Investigator: Haorong WU, M.D.         
Principal Investigator: Yongyou WU, M.D.         
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Xinguo ZHU, M.D.       zxg45@hotmail.com   
Contact: Zhongqi MAO    M.D.    maozq31@hotmail.com   
Principal Investigator: Xinguo ZHU, M.D.         
Principal Investigator: Zhongqi MAO, M.D.         
The First People's Hospital of Taicang Recruiting
Suzhou, Jiangsu, China, 215400
Contact: Yi WANG, M.D.         
Contact: Bing WANG, M.D.         
Principal Investigator: Yi WANG, M.D.         
The Second People's Hospital of Changshu City Recruiting
Suzhou, Jiangsu, China, 215500
Contact: Guoqiang ZHOU, M.D.         
Principal Investigator: Guoqiang ZHOU, M.D.         
Zhangjiagang First People's Hospital Recruiting
Suzhou, Jiangsu, China, 215600
Contact: Shusheng WANG, M.D.       Wsszyy2005@163.com   
Principal Investigator: Shusheng WANG, M.D.         
Sub-Investigator: Liang ZHOU, M.D.         
The Taizhou People's Hospital Recruiting
Taizhou, Jiangsu, China, 225300
Contact: Qinghong LIU, M.D.         
Contact: Honggang WANG, M.D.         
Principal Investigator: Qinghong LIU, M.D.         
The 101 Hospital of the Chinese People's Liberation Army Recruiting
Wuxi, Jiangsu, China, 214000
Contact: Guozhong WU, M.D.       jfj101hwugz@sina.cn   
Principal Investigator: Guozhong WU, M.D.         
Affiliated Hospital of Jiangnan University, The Forth People's Hospital of Wuxi Recruiting
Wuxi, Jiangsu, China, 214062
Contact: Bojian FEI, M.D.       wx4yfbj@163.com   
Principal Investigator: Bojian FEI, M.D.         
Xuzhou Central Hospital Recruiting
Xuzhou, Jiangsu, China, 221009
Contact: Xiaopeng LV, M.D.       18952171977@126.com   
Principal Investigator: Xiaopeng LV, M.D.         
Northern Jiangsu People's Hospital Recruiting
Yangzhou, Jiangsu, China, 225001
Contact: Ping CHEN, M.D.       chen86ky@126.com   
Contact: Xinxin LIU, M.D.         
Principal Investigator: Ping CHEN, M.D.         
Principal Investigator: Daorong WANG, M.D.         
Sub-Investigator: Xinxin LIU, M.D.         
Affiliated Hospital of Jiangsu University Recruiting
Zhenjiang, Jiangsu, China, 212001
Contact: Jixiang CHEN, M.D.       cyok9@163.com   
Principal Investigator: Jixiang CHEN, M.D.         
Affiliated People's Hospital of Jiangsu University Recruiting
Zhenjiang, Jiangsu, China, 212002
Contact: Pengcheng JIANG, M.D.       jpc18906106623@126.com   
Contact: Shouliang ZHANG, M.D.         
Principal Investigator: Pengcheng JIANG, M.D.         
Sponsors and Collaborators
Jinling Hospital, China
Investigators
Principal Investigator: Zhi-Wei JIANG Jinling Hospital, Medical School of Nanjing University
Study Director: Jian ZHAO Jinling Hospital, Medical School of Nanjing University
Study Director: Gang WANG Jinling Hospital, Medical School of Nanjing University
Study Director: Jiang LIU Jinling Hospital, Medical School of Nanjing University

Responsible Party: Jian ZHAO, Vice director of Research Institute of General Surgery, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT03126058     History of Changes
Other Study ID Numbers: BE2015687C
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jian ZHAO, Jinling Hospital, China:
enhanced recovery after surgery
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases