Laparoscopic Complete Mesocolic Excision on Colon Cancer (LCME)

This study is currently recruiting participants.
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

June 20, 2012
July 16, 2013
June 2012
June 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01628250 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Laparoscopic Complete Mesocolic Excision on Colon Cancer
Clinical Research on the Efficacy and Feasibility of Laparoscopic Complete Mesocolic Excision on Colon Cancer: A Randomized Controlled Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Operation Finding
  • Complications
  • Pathology
  • Quality of Life
  • Neoplasms Recurrence
  • 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)
  • 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
  • Active Comparator: laparoscopic complete mesocolic excision
    Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision
    Intervention: Procedure: laparoscopic complete mesocolic excision
  • Active Comparator: D3 laparoscopic colectomy
    Randomized group of patients receiving laparoscopic colectomy with D3-resection
    Intervention: Procedure: D3-laparoscopic colectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
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
China
 
NCT01628250
SH-MIS
Yes
Bo Feng, Ruijin Hospital
Bo Feng
Not Provided
Principal Investigator: Bo Feng, MD/PhD Shanghai Minimally Invasive Surgery Center
Ruijin Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP