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Laparoscopic Complete Mesocolic Excision on Colon Cancer (LCME)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628250
First Posted: June 26, 2012
Last Update Posted: June 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bo Feng, Ruijin Hospital
June 20, 2012
June 26, 2012
November 7, 2015
June 29, 2016
June 29, 2016
June 2012
October 2015   (Final data collection date for primary outcome measure)
Histopathological Outcomes Obtained Through the Surgeries [ Time Frame: 14 days after the surgery ]
number of lymph nodes retrieved
Histopathological Outcomes Obtained Through the Surgeries [ Time Frame: 14 days after the surgery ]
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.
Complete list of historical versions of study NCT01628250 on ClinicalTrials.gov Archive Site
Survival Rate [ Time Frame: 3 years after the surgery ]
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: None (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.
 
Completed
99
October 2015
October 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
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01628250
SH-MIS
Yes
Not Provided
Not Provided
Bo Feng, Ruijin Hospital
Bo Feng
Not Provided
Principal Investigator: Bo Feng, MD/PhD Shanghai Minimally Invasive Surgery Center
Ruijin Hospital
May 2016

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