Colorectal Cancer
Conditions
Brief summary
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.
Interventions
PROCEDURElaparoscopic surgery
surgery would be performed by laparoscope
PROCEDUREopen surgery
surgery would be performed by traditional surgery.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * Pathologically confirmed adenocarcinoma * Pre-surgery image staging as (CT/MRI):T2-3,N0-2,M0,(TNM stage，AJCC，version of 2003) * Single tumor locating at cecum, ascending colon, descending colon, sigmoid colon, rectosigmoid junction, rectum(distance from anal verge more than 7cm) * Tumor diameter less than 6cm * Age 18-75 year * ECOG 0-2 * Predicted survival longer than 6 months * Normal liver, renal, bone marrow function: (GPT less than 2 ULN，total bilirubin less than 1.5mg/dl，Cr less than 1.5 ULN，WBC more than 4×109/L，PLT more than 100×109/L) * No previous history of gastrointestinal surgery * No previous history of chemotherapy or radiotherapy
Exclusion criteria
* Severe and uncontrolled medical disease including unstable angina pectoris, cardiac infarction and cerebral attack in 6 months * Could not tolerant general anesthesia or surgery for other organ dis-function * Allergy to chemotherapeutical agents in the protocol * History of other malignant tumor within 5 years * Severe mental disorder * Continued systematic steroid therapy * Woman during pregnancy or lactation * Under study of other clinical trial * No compliance of the protocol * Discovery of distant metastasis during surgery * Postsurgery stage of I or IV tumors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival rate | 3 year |
| tumor residual rate of LRM and CRM | 1 week |
| operation mortality | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| blood lost | during operation |
| analgesic dosage | 1,2 and 3 days post surgery |
| evacuating time | post surgery |
| survival rate | 3 year |
| transfer to open surgery | during operation |
| fee | peri-operation |
| operation morbidity | 2 months |
| local recurrence rate | 5 year |
| operation time | at the end of operation |
Countries
China
Contacts
Primary Contactjin wang, doctor
Backup Contactxiaotian zhang, doctor
Outcome results
None listed