Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
Not Applicable
Not yet recruiting
- Conditions
- Colorectal Cancer
- Interventions
- Procedure: Laparoscopic colorectal cancer resectionProcedure: Colorectal cancer resection via minilaparotomy
- Registration Number
- NCT03843398
- Lead Sponsor
- Changhai Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 992
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopy Group Laparoscopic colorectal cancer resection Participants in this arm undergo laparoscopic colorectal cancer resection. Minilaparotomy Group Colorectal cancer resection via minilaparotomy Participants in this arm undergo colorectal cancer resection via minilaparotomy.
- Primary Outcome Measures
Name Time Method 3-year overall survival, 3y OS 3 years after the follow up of the last patient enrolled. 3y OS
- Secondary Outcome Measures
Name Time Method Postoperative complications Incidence at 30 days 30 days after the operation of the last patient enrolled. PCI30
3-year disease free survival, 3y DFS 3 years after the follow up of the last patient enrolled. 3y DFS
Postoperative mortality at 30 days 30 days after the operation of the last patient enrolled. PM30
5-year overall survival, 5y OS 5 years after the follow up of the last patient enrolled. 5y OS
Local recurrence rate, LRR 3 years after the follow up of the last patient enrolled. LRR
5-year disease free survival, 3y DFS 5 years after the follow up of the last patient enrolled. 5y DFS