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Laparoscopic surgery has been widely accepted for its minimal invasion and safety. However, whether it has the same survival benefit as the traditional open surgery in Chinese population is still unknown. So we designed this study to evaluate the 3 year disease free survival rate in the laparoscopic group versus the open surgery group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | laparoscopic surgery plus postsurgery adjuvant chemotherapy of FOLFOX4 |
|
| B | Active Comparator | open surgery plus postsurgery adjuvant chemotherapy of FOLFOX4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic surgery | Procedure | surgery would be performed by laparoscope |
| |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival rate | 3 year | |
| tumor residual rate of LRM and CRM | 1 week | |
| operation mortality | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| survival rate | 3 year | |
| survival rate | 5 year | |
| local recurrence rate |
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Inclusion Criteria:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jin wang, doctor | Contact | 86-10-63138712 | zhangzht@medmail.com.cn | |
| xiaotian zhang, doctor | Contact | 86-10-88196561 | zhangxtxx@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| zhongtao zhang, doctor | beijing friendship hospital, department of general surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Department of General Surgery | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| D061887 | Conversion to Open Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| open surgery |
| Procedure |
surgery would be performed by traditional surgery. |
|
| 5 year |
| operation time | at the end of operation |
| blood lost | during operation |
| analgesic dosage | 1,2 and 3 days post surgery |
| evacuating time | post surgery |
| operation morbidity | 2 months |
| transfer to open surgery | during operation |
| fee | peri-operation |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |