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NCT01628250 Clinical Trial

Laparoscopic Complete Mesocolic Excision on Colon Cancer

Quality of Life Clinical Trial

— LCME  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01628250
Other study ID # SH-MIS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2012
Est. completion date October 2015

Study information
Verified date October 2022
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• laparoscopic complete mesocolic excision
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.
• D3-laparoscopic colectomy
D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.

Locations
Country Name City State
China Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Bo Feng

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Histopathological Outcomes Obtained Through the Surgeries number of lymph nodes retrieved 14 days after the surgery
Secondary Survival Rate The follow up to the patients after the surgery to evaluate the oncological results of the technique 3 years after the surgery
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