Back to resultsLaparoscopic Complete Mesocolic Excision on Colon Cancer (LCME)
Primary Purpose
Operation Finding, Complications, Pathology
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic complete mesocolic excision
D3-laparoscopic colectomy
Sponsored by
About this trial
This is an interventional treatment trial for Operation Finding
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
Sites / Locations
- Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
laparoscopic complete mesocolic excision
D3 laparoscopic colectomy
Arm Description
Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision
Randomized group of patients receiving laparoscopic colectomy with D3-resection
Outcomes
Primary Outcome Measures
Histopathological Outcomes Obtained Through the Surgeries
number of lymph nodes retrieved
Secondary Outcome Measures
Survival Rate
The follow up to the patients after the surgery to evaluate the oncological results of the technique
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01628250
Brief Title
Laparoscopic Complete Mesocolic Excision on Colon Cancer
Acronym
LCME
Official Title
Clinical Research on the Efficacy and Feasibility of Laparoscopic Complete Mesocolic Excision on Colon Cancer: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bo Feng
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Operation Finding, Complications, Pathology, Quality of Life, Neoplasms Recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic complete mesocolic excision
Arm Type
Active Comparator
Arm Description
Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision
Arm Title
D3 laparoscopic colectomy
Arm Type
Active Comparator
Arm Description
Randomized group of patients receiving laparoscopic colectomy with D3-resection
Intervention Type
Procedure
Intervention Name(s)
laparoscopic complete mesocolic excision
Other Intervention Name(s)
laparoscopic CME, Complete Medial Approach (CMA), Hybrid Medial Approach (HMA)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
D3-laparoscopic colectomy
Other Intervention Name(s)
D3 laparoscopic colectomy
Intervention Description
D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.
Primary Outcome Measure Information:
Title
Histopathological Outcomes Obtained Through the Surgeries
Description
number of lymph nodes retrieved
Time Frame
14 days after the surgery
Secondary Outcome Measure Information:
Title
Survival Rate
Description
The follow up to the patients after the surgery to evaluate the oncological results of the technique
Time Frame
3 years after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Feng, MD/PhD
Organizational Affiliation
Shanghai Minimally Invasive Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Learn more about this trial
Laparoscopic Complete Mesocolic Excision on Colon Cancer
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