Laparoscopic Complete Mesocolic Excision on Colon Cancer (LCME)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2013 by Ruijin Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Bo Feng, Ruijin Hospital Identifier:
First received: June 20, 2012
Last updated: July 16, 2013
Last verified: July 2013
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.

Condition Intervention
Operation Finding
Quality of Life
Neoplasms Recurrence
Procedure: laparoscopic complete mesocolic excision
Procedure: D3-laparoscopic colectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Research on the Efficacy and Feasibility of Laparoscopic Complete Mesocolic Excision on Colon Cancer: A Randomized Controlled Study

Resource links provided by NLM:

Further study details as provided by Ruijin Hospital:

Primary Outcome Measures:
  • Histopathological outcomes obtained through the surgeries [ Time Frame: 14 days after the surgery ] [ Designated as safety issue: No ]
    The contents of histopathological outcomes are obtained from the surgeries, including the tissue morphometry; number of lymph nodes retrieved; and the plane of the resected mesocolon etc.

Secondary Outcome Measures:
  • Survival rate [ Time Frame: 3 years after the surgery ] [ Designated as safety issue: No ]
    The follow up to the patients after the surgery to evaluate the oncological results of the technique

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: laparoscopic complete mesocolic excision
Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision
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.
Other Names:
  • laparoscopic CME
  • Complete Medial Approach (CMA)
  • Hybrid Medial Approach (HMA)
Active Comparator: D3 laparoscopic colectomy
Randomized group of patients receiving laparoscopic colectomy with D3-resection
Procedure: D3-laparoscopic colectomy
D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.
Other Name: D3 laparoscopic colectomy


Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01628250

Contact: Bo Feng, MD/PhD 86-21-64370045 ext 664566
Contact: Min Hua Zheng, MD 86-21-64370045 ext 664553

China, Shanghai
Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Bo Feng, MD/PhD    86-21-64370045 ext 664566   
Sponsors and Collaborators
Bo Feng
Principal Investigator: Bo Feng, MD/PhD Shanghai Minimally Invasive Surgery Center
  More Information

Responsible Party: Bo Feng, Research chair of MIS, Ruijin Hospital Identifier: NCT01628250     History of Changes
Other Study ID Numbers: SH-MIS 
Study First Received: June 20, 2012
Last Updated: July 16, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes processed this record on May 30, 2016