Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, Minilaparotomy, Survival
Brief summary
The primary aim of this study is \- to determine the difference of survival outcome (3-year overall survival, 3y OS) between after minilaparotomy and after laparoscopy.. Other aims include to determine the data below when minilaparotomy and laparoscopy are compared with each other. * 3-year disease free survival, 3y DFS * 5-year overall survival, 5y OS * 5-year disease free survival, 5y DFS * Local recurrence rate, LRR * Postoperative complications Incidence and mortality at 30 days
Interventions
PROCEDUREColorectal cancer resection via minilaparotomy
According to the cancer location, a 7 cm incision is made in specific area of the patient's abdomen. The whole procedure of operation will be finished within this incision. If the incision must be lengthen due to the surgical demand, the failure of the minilaparotomy is determined.
This is one of the routine procedures used for colorectal cancer resection.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Colorectal cancer with pathological results. * Colorectal cancer preliminary diagnosed during colonoscopy. * No confirmed metastasis. * No comorbidity of other malignancy. * The primary tumor is less than 10 cm. * No organ dysfunction. * The patient and his families totally agree with the whole investigative procedure, and sign the written informed consent form.
Exclusion criteria
* Diagnosed with any other malignancy within 5 years. * Comorbidity of emergent conditions like perforation. * Former colorectal surgery history which may affects digestive tract reconstruction. * Need combined organ resection. * ASA grade IV or V. * Pregnant or lactating Women. * Severe mental diseases. * Severe cardiopulmonary diseases which reduce operation tolerance. * Systematic steroid therapy lasting for more than 1 month. * Intolerant of laparoscopy. * No written informed consent form signed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival, 3y OS | 3 years after the follow up of the last patient enrolled. | 3y OS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival, 3y DFS | 3 years after the follow up of the last patient enrolled. | 3y DFS |
| 5-year disease free survival, 3y DFS | 5 years after the follow up of the last patient enrolled. | 5y DFS |
| 5-year overall survival, 5y OS | 5 years after the follow up of the last patient enrolled. | 5y OS |
| Postoperative complications Incidence at 30 days | 30 days after the operation of the last patient enrolled. | PCI30 |
| Postoperative mortality at 30 days | 30 days after the operation of the last patient enrolled. | PM30 |
| Local recurrence rate, LRR | 3 years after the follow up of the last patient enrolled. | LRR |
Contacts
Primary ContactZi-Ye ZHAO, MD
Outcome results
None listed