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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03126058
Recruitment Status : Unknown
Verified April 2018 by Jian ZHAO, Jinling Hospital, China.
Recruitment status was:  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Locations
Show Show 23 study locations
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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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
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Responsible Party: Jian ZHAO, Vice director of Research Institute of General Surgery, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT03126058    
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

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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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases