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Laparoscopic Complete Mesocolic Excision on Colon Cancer (LCME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bo Feng, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01628250
First received: June 20, 2012
Last updated: May 21, 2016
Last verified: May 2016
  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 ]
    number of lymph nodes retrieved


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


Enrollment: 99
Study Start Date: June 2012
Study Completion Date: October 2015
Primary Completion Date: October 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   (Adult, Senior)
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

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 
Study First Received: June 20, 2012
Results First Received: November 7, 2015
Last Updated: May 21, 2016
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on September 26, 2016