Laparoscopic Complete Mesocolic Excision on Colon Cancer (LCME)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Ruijin Hospital
Sponsor:
Information provided by (Responsible Party):
Bo Feng, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01628250
First received: June 20, 2012
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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
Complications
Pathology
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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01628250

Contacts
Contact: Bo Feng, MD/PhD 86-21-64370045 ext 664566 fengbo2022@163.com
Contact: Min Hua Zheng, MD 86-21-64370045 ext 664553 fb11427@rjh.com.cn

Locations
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    fengbo2022@163.com   
Sponsors and Collaborators
Bo Feng
Investigators
Principal Investigator: Bo Feng, MD/PhD Shanghai Minimally Invasive Surgery Center
  More Information

No publications provided

Responsible Party: Bo Feng, Research chair of MIS, Ruijin Hospital
ClinicalTrials.gov 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:
Recurrence
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014