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This study is aimed to evaluate the safety of applying enhanced recovery after surgery for colorectal cancer.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enhanced recovery after surgery | Experimental | enhanced recovery after surgery includes:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enhanced recovery after surgery | Procedure | Patients will undergo enhanced recovery after surgery programs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| occurrence rate of severe complications | including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence rate of ordinary complications | Except severe complications, Clavien-Dindo classification ≥Ⅱ complications need not reoperation | 1 month |
| Readmission rate within 30 days after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi-Wei JIANG, Ph.D. | Contact | 8602580860034 | nzjiangzhiwei@163.com | |
| Jian ZHAO, Ph.D. | Contact | 8602580860034 | zhaojiangogo@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhi-Wei JIANG | Jinling Hospital, Medical School of Nanjing University | Principal Investigator |
| Jian ZHAO | Jinling Hospital, Medical School of Nanjing University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Changzhou | Recruiting | Changzhou | Jiangsu | 213003 | China |
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Patients will receive enhanced recovery after surgery programs.
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Readmission rate within 30 days after discharge
| 1 month |
| Ideal postoperative length of hospital stay | reach discharge criteria | 1 month |
| Actual postoperative length of hospital stay | Actual postoperative length of hospital stay | 1 month |
| Operative time | duration of operation | 1 day |
| Blood loss | Blood loss | 1 day |
| Intraoperative infusion | Intraoperative infusion | 1 day |
| TNM classification | classification of tumor | 1 week |
| Number of dissected lymph node | Number of dissected lymph node | 1 week |
| Time to first flatus | Bowel function recovery | 2 week |
| Time to first defecation | Bowel function recovery | 2 week |
| Time to first semi-liquid diet | Bowel function recovery | 2 week |
| Time to first off-bed activity | Postoperative activity | 1 week |
| Time of off-bed activity per day | Postoperative activity | 1 week |
| Distance of off-bed activity per day | Postoperative activity | 1 week |
| Postoperative pain | VAS classification | 1 week |
| Hospital cost | Hospital cost | 1 month |
| Management of catheters | including nasogastric tube, catheter, intraperitoneal drain, infusion tube | 1 month |
| Preoperative length of hospital stay | Preoperative length of hospital stay | 1 month |
| CD3+ | Immune indicators | 1 week |
| CD4+ | Immune indicators | 1 week |
| CD4+/CD8+ | Immune indicators | 1 week |
| IL-6 | Inflammatory indicators | 1 week |
| CRP | Inflammatory indicators | 1 week |
| Albumin | Nutritional indicators | 1 week |
| Prealbumin | Nutritional indicators | 1 week |
| Transferrin | Nutritional indicators | 1 week |
| Hb | Nutritional indicators | 1 week |
| WBC | Nutritional indicators | 1 week |
| PLT | Nutritional indicators | 1 week |
| HCT | Nutritional indicators | 1 week |
| Blood glucose | Nutritional indicators | 1 week |
| Procalcitonin | Infectious indicator | 1 week |
| Gang WANG |
| Jinling Hospital, Medical School of Nanjing University |
| Study Director |
| Jiang LIU | Jinling Hospital, Medical School of Nanjing University | Study Director |
| Changzhou Second People's Hospital Affiliated to Nanjing Medical University | Recruiting | Changzhou | Jiangsu | 213164 | China |
|
| The First People's Hospital of Lianyungang City | Recruiting | Lianyungang | Jiangsu | 222002 | China |
|
| The Second People's Hospital of Lianyungang City | Recruiting | Lianyungang | Jiangsu | 222006 | China |
|
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| Jinling Hospital, Medical School of Nanjing University | Recruiting | Nanjing | Jiangsu | 210002 | China |
|
| Zhongda Hospital, Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
|
| The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210011 | China |
|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
|
| Suqian People's Hospital, Nanjing Drum Tower Hospital | Recruiting | Suqian | Jiangsu | 223800 | China |
|
| Suzhou Municipal Hospital | Recruiting | Suzhou | Jiangsu | 215000 | China |
|
| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215004 | China |
|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
|
| The First People's Hospital of Taicang | Recruiting | Suzhou | Jiangsu | 215400 | China |
|
| The Second People's Hospital of Changshu City | Recruiting | Suzhou | Jiangsu | 215500 | China |
|
| Zhangjiagang First People's Hospital | Recruiting | Suzhou | Jiangsu | 215600 | China |
|
| The Taizhou People's Hospital | Recruiting | Taizhou | Jiangsu | 225300 | China |
|
| The 101 Hospital of the Chinese People's Liberation Army | Recruiting | Wuxi | Jiangsu | 214000 | China |
|
| Affiliated Hospital of Jiangnan University, The Forth People's Hospital of Wuxi | Recruiting | Wuxi | Jiangsu | 214062 | China |
|
| Xuzhou Central Hospital | Recruiting | Xuzhou | Jiangsu | 221009 | China |
|
| Northern Jiangsu People's Hospital | Recruiting | Yangzhou | Jiangsu | 225001 | China |
|
| Affiliated Hospital of Jiangsu University | Recruiting | Zhenjiang | Jiangsu | 212001 | China |
|
| Affiliated People's Hospital of Jiangsu University | Recruiting | Zhenjiang | Jiangsu | 212002 | China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
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