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Laparoscopic Complete Mesocolic Excision on Colon Cancer (LCME)

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ClinicalTrials.gov Identifier: NCT01628250
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : June 29, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Operation Finding Complications Pathology Quality of Life Neoplasms Recurrence Procedure: laparoscopic complete mesocolic excision Procedure: D3-laparoscopic colectomy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2012
Primary Completion Date : October 2015
Study Completion Date : October 2015
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Histopathological Outcomes Obtained Through the Surgeries [ Time Frame: 14 days after the surgery ]
    number of lymph nodes retrieved


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628250


Locations
China, Shanghai
Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Bo Feng
Investigators
Principal Investigator: Bo Feng, MD/PhD Shanghai Minimally Invasive Surgery Center
More Information

Responsible Party: Bo Feng, Research chair of MIS, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01628250     History of Changes
Other Study ID Numbers: SH-MIS
First Posted: June 26, 2012    Key Record Dates
Results First Posted: June 29, 2016
Last Update Posted: June 29, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Colonic Neoplasms
Recurrence
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes