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Trial record 21 of 1000 for:    colon cancer AND resection

Laparoscopic Complete Mesocolic Excision on Colon Cancer (LCME)

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.
 
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):
Bo Feng, Ruijin Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 99
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Laparoscopic Complete Mesocolic Excision D3 Laparoscopic Colectomy
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 49 50
Completed 49 50
Not Completed 0 0
Arm/Group Title Laparoscopic Complete Mesocolic Excision D3 Laparoscopic Colectomy Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 49 50 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 99 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  40.8%
22
  44.0%
42
  42.4%
>=65 years
29
  59.2%
28
  56.0%
57
  57.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 99 participants
Female
26
  53.1%
24
  48.0%
50
  50.5%
Male
23
  46.9%
26
  52.0%
49
  49.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 49 participants 50 participants 99 participants
49 50 99
1.Primary Outcome
Title Histopathological Outcomes Obtained Through the Surgeries
Hide Description number of lymph nodes retrieved
Time Frame 14 days after the surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laparoscopic Complete Mesocolic Excision D3 Laparoscopic Colectomy
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 49 50
Mean (Standard Deviation)
Unit of Measure: nodes
20.3  (5.8) 19.2  (6.7)
2.Secondary Outcome
Title Survival Rate
Hide Description The follow up to the patients after the surgery to evaluate the oncological results of the technique
Time Frame 3 years after the surgery
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Laparoscopic Complete Mesocolic Excision D3 Laparoscopic Colectomy
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Laparoscopic Complete Mesocolic Excision D3 Laparoscopic Colectomy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Laparoscopic Complete Mesocolic Excision D3 Laparoscopic Colectomy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/49 (24.49%)      19/50 (38.00%)    
Surgical and medical procedures     
vessel-related complication  12/49 (24.49%)  12 19/50 (38.00%)  19
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Laparoscopic Complete Mesocolic Excision D3 Laparoscopic Colectomy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      0/50 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bo Feng
Organization: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Phone: 021-64458887
EMail: fengbo2022@163.com
Layout table for additonal information
Responsible Party: Bo Feng, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01628250     History of Changes
Other Study ID Numbers: SH-MIS
First Submitted: June 20, 2012
First Posted: June 26, 2012
Results First Submitted: November 7, 2015
Results First Posted: June 29, 2016
Last Update Posted: June 29, 2016