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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
Results First Received: November 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Operation Finding
Complications
Pathology
Quality of Life
Neoplasms Recurrence
Interventions: Procedure: laparoscopic complete mesocolic excision
Procedure: D3-laparoscopic colectomy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Laparoscopic Complete Mesocolic Excision

Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision

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.

D3 Laparoscopic Colectomy

Randomized group of patients receiving laparoscopic colectomy with D3-resection

D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.


Participant Flow:   Overall Study
    Laparoscopic Complete Mesocolic Excision     D3 Laparoscopic Colectomy  
STARTED     49     50  
COMPLETED     49     50  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Laparoscopic Complete Mesocolic Excision

Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision

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.

D3 Laparoscopic Colectomy

Randomized group of patients receiving laparoscopic colectomy with D3-resection

D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.

Total Total of all reporting groups

Baseline Measures
    Laparoscopic Complete Mesocolic Excision     D3 Laparoscopic Colectomy     Total  
Number of Participants  
[units: participants]
  49     50     99  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     22     42  
>=65 years     29     28     57  
Gender  
[units: participants]
     
Female     26     24     50  
Male     23     26     49  
Region of Enrollment  
[units: participants]
     
China     49     50     99  



  Outcome Measures

1.  Primary:   Histopathological Outcomes Obtained Through the Surgeries   [ Time Frame: 14 days after the surgery ]

2.  Secondary:   Survival Rate   [ Time Frame: 3 years after the surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Bo Feng
Organization: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
phone: 021-64458887
e-mail: fengbo2022@163.com



Responsible Party: Bo Feng, 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