Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer

Study Overview
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Brief Summary
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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

Official Title
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Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Colorectal cancer resection via minilaparotomy
* Procedure: Laparoscopic colorectal cancer resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minilaparotomy Group<br>Participants in this arm undergo colorectal cancer resection via minilaparotomy. | Procedure: Colorectal cancer resection via minilaparotomy<br>* 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.<br>* Other names: Minilaparotomy;|
| Active Comparator: Laparoscopy Group<br>Participants in this arm undergo laparoscopic colorectal cancer resection. | Procedure: Laparoscopic colorectal cancer resection<br>* This is one of the routine procedures used for colorectal cancer resection.<br>* Other names: Laparoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival, 3y OS | 3y OS | 3 years after the follow up of the last patient enrolled. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival, 5y OS | 5y OS | 5 years after the follow up of the last patient enrolled. | 
| 3-year disease free survival, 3y DFS | 3y DFS | 3 years after the follow up of the last patient enrolled. | 
| 5-year disease free survival, 3y DFS | 5y DFS | 5 years after the follow up of the last patient enrolled. | 
| Local recurrence rate, LRR | LRR | 3 years after the follow up of the last patient enrolled. | 
| Postoperative complications Incidence at 30 days | PCI30 | 30 days after the operation of the last patient enrolled. | 
| Postoperative mortality at 30 days | PM30 | 30 days after the operation of the last patient enrolled. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Minilaparotomy, Survival