Enhanced Recovery After Surgery Program for Colorectal Cancer: a Multi-center Study (ERASC1)
ERASC1
1 other identifier
interventional
1,000
1 country
23
Brief Summary
This study is aimed to evaluate the safety of applying enhanced recovery after surgery for colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Jun 2017
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedStudy Start
First participant enrolled
June 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedApril 30, 2018
April 1, 2018
1.2 years
April 20, 2017
April 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
occurrence rate of severe complications
including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation
1 month
Secondary Outcomes (33)
Occurrence rate of ordinary complications
1 month
Readmission rate within 30 days after discharge
1 month
Ideal postoperative length of hospital stay
1 month
Actual postoperative length of hospital stay
1 month
Operative time
1 day
- +28 more secondary outcomes
Study Arms (1)
enhanced recovery after surgery
EXPERIMENTALenhanced 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
Interventions
Patients will undergo enhanced recovery after surgery programs.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 pressure≥180mmHg or diastolic pressure≥110mmHg).
- 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 (albumin≤30g/L, weight loss in half a year\>10%, SGA classification C, BMI\<18, Hb\<70g/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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Changzhou Second People's Hospital Affiliated to Nanjing Medical University
Changzhou, Jiangsu, 213164, China
The First People's Hospital of Lianyungang City
Lianyungang, Jiangsu, 222002, China
The Second People's Hospital of Lianyungang City
Lianyungang, Jiangsu, 222006, China
Nanjing First Hospital
Nanjing, Jiangsu, 210000, China
Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210002, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Suqian People's Hospital, Nanjing Drum Tower Hospital
Suqian, Jiangsu, 223800, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The First People's Hospital of Taicang
Suzhou, Jiangsu, 215400, China
The Second People's Hospital of Changshu City
Suzhou, Jiangsu, 215500, China
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, 215600, China
The Taizhou People's Hospital
Taizhou, Jiangsu, 225300, China
The 101 Hospital of the Chinese People's Liberation Army
Wuxi, Jiangsu, 214000, China
Affiliated Hospital of Jiangnan University, The Forth People's Hospital of Wuxi
Wuxi, Jiangsu, 214062, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
Affiliated People's Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice director of Research Institute of General Surgery
Study Record Dates
First Submitted
April 20, 2017
First Posted
April 24, 2017
Study Start
June 21, 2017
Primary Completion
August 31, 2018
Study Completion
December 31, 2018
Last Updated
April 30, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share