Back to resultsThe Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment
Primary Purpose
Cancer Colon
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total Mesocolic Excision with Central Vessel Ligation
conventional surgery of cancer colon
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Colon focused on measuring cancer colon
Eligibility Criteria
Inclusion Criteria:
• Adult male and female Age of or above 18 years.
- Tumor localization at the caecum, ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid on preoperative endoscopy and radiographic imaging [barium enema or computed tomography (CT)]
- No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease
- Written informed consent
Exclusion Criteria:
• Contraindications to major surgery and American Society of Anaesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment.
- Infectious disease requiring treatment.
- Pregnant women
- Use of systemic steroids.
- Severe pulmonary emphysema or pulmonary fibrosis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
patients for whom Complete mesocolic excision will be done
patients had conventional surgery before
Arm Description
Outcomes
Primary Outcome Measures
Lymph nodes harvest
Number of retrieved lymph nodes can be extracted by this technique
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04079946
Brief Title
The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment
Official Title
The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cancer Colon is one of the major public health problems worldwide. Complete eradication of the tumor with no recurrence or residual masses is a challenge which faces all the surgeons and medical staff all over the world. A lot of techniques were used to ensure 100 % eradication of the tumor and to cure the patients from cancer. Total Mesocolic Excision with Central Vessel Ligation is one of the recent techniques used for colon cancer surgeries. Here in the research the investigators answer the question of how this technique is superior and more beneficial in complete eradication of the tumor than the conventional surgery for colon cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Colon
Keywords
cancer colon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients for whom Complete mesocolic excision will be done
Arm Type
Active Comparator
Arm Title
patients had conventional surgery before
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Total Mesocolic Excision with Central Vessel Ligation
Intervention Description
sharp dissection of the anatomical layers and the dissection of the visceral plane from the parietal one . In addition a central division of the feeding arteries at their origins is performed at the level of superior mesenteric artery for tumors of the right colon and at the level of inferior mesenteric artery or the aorta for tumors of the left colon .this allows for removal of the maximum number of lymph nodes possible.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery of cancer colon
Intervention Description
removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon
Primary Outcome Measure Information:
Title
Lymph nodes harvest
Description
Number of retrieved lymph nodes can be extracted by this technique
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Adult male and female Age of or above 18 years.
Tumor localization at the caecum, ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid on preoperative endoscopy and radiographic imaging [barium enema or computed tomography (CT)]
No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease
Written informed consent
Exclusion Criteria:
• Contraindications to major surgery and American Society of Anaesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment.
Infectious disease requiring treatment.
Pregnant women
Use of systemic steroids.
Severe pulmonary emphysema or pulmonary fibrosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr E. Hassan, resident Doctor
Phone
01004664295
Email
amrelfayed@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa A. Hassanein, professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed B. Kotb, profeesor
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahmoud T. Ahmed, lecturer
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment
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