Laparoscopic Complete Mesocolic Excision on Colon Cancer

Study Overview
=================
Brief Summary
-----------------
Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery technique to perform a resection for colon cancer. Besides, the segment of the colon containing the tumor, the resection area should include an intact mesocolon as an envelope to encase the possible route for metastasis. The routes include blood vessels, lymphatic drain and etc. Such hypothesis predicts better histopathological and higher oncological results which turns into better survival rate and better quality of life.

Official Title
-----------------
Clinical Research on the Efficacy and Feasibility of Laparoscopic Complete Mesocolic Excision on Colon Cancer: A Randomized Controlled Study

Conditions
-----------------
Operation Finding, Complications, Pathology, Quality of Life, Neoplasms Recurrence

Intervention / Treatment
-----------------
* Procedure: laparoscopic complete mesocolic excision
* Procedure: D3-laparoscopic colectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pathologically confirmed colon cancer Signed consent Exclusion Criteria: History of malignancy Intestinal obstruction or perforation Evidence of metastasis by preoperative examinations Deformity of spine Emergency case BMI > 29

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic complete mesocolic excision<br>Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision | Procedure: laparoscopic complete mesocolic excision<br>* laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized.<br>* Other names: Hybrid Medial Approach (HMA);|
| Active Comparator: D3 laparoscopic colectomy<br>Randomized group of patients receiving laparoscopic colectomy with D3-resection | Procedure: D3-laparoscopic colectomy<br>* D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.<br>* Other names: D3 laparoscopic colectomy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathological Outcomes Obtained Through the Surgeries | number of lymph nodes retrieved | 14 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate | The follow up to the patients after the surgery to evaluate the oncological results of the technique | 3 years after the surgery |