Compare Outcomes After High and Low Ligation of Inferior Mesenteric Artery in Colorectal Cancer
Evaluation of Clinical and Oncological Outcomes After High and Low Ligation of Inferior Mesenteric Artery in Elective Left-sided Colon and Rectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Colon cancer represents a significant clinical surgical burden, accounting for approximately 10% of all cancer cases. It is assumed that it is the second leading cause of cancer-related deaths worldwide. Surgery and chemotherapy are considered the main lines of treatment.
Left colonic and rectal cancers represent approximately two-thirds of all colorectal malignancies. The mainstay of treatment is surgical resection, including tumor removal with adequate safety margins with adequate lymphadenectomy.
Several lifestyle factors contribute to the development of colorectal cancer, such as a high intake of processed meats and low intake of fruits and vegetables, a sedentary lifestyle, obesity, smoking, and excessive alcohol consumption.
In colon and rectal cancer surgery, the approach toward the inferior mesenteric artery (IMA) has always been debated among surgeons regarding the "high tie" and "low tie" techniques.
According to the consensus statement of definitions of anorectal Physiology and Rectal Cancer of the American Society of Colon and Rectal Surgeons (ASCRS), a low tie of the IMA is meant as a ligation after the origin of the left colic artery. In contrast, the high tie a ligation of the IMA at its aortic root.
High ligation of the IMA for rectal and left colonic cancers may improve lymph node yield rate, thus facilitating more accurate tumor staging and better oncological outcomes. Several studies have shown the importance of lymph node dissection up to the root of the IMA in terms of better survival and precise staging. The high ligation also enables tension-free colonic anastomosis during low anterior resection. However, high ligation of the IMA has been known to decrease blood flow to the anastomosis, increasing the risk of anastomotic leak.
In contrast, the low-ligation technique allows for adequate blood supply to the colon proximal to the anastomotic stoma during low anterior resection that might prevent vascular inefficiency of the anastomotic marginal colic arteries and decrease the risk of anastomotic leak, especially in elderly patients.
On the other hand, low ligation limits the opportunity for lymph node clearance at the origin of the IMA. This incomplete lymphatic clearance may decrease survival while increasing the possibility of metastasis and cancer recurrence.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed R Mohamed, MD
- Phone Number: 002 01128056501
- Email: mohamed_mourad1@med.sohag.edu.eg
Study Contact Backup
- Name: Emad A Ahmed, MD
- Phone Number: 002 01128056501
- Email: mohamed_mourad1@med.sohag.edu.eg
Study Locations
-
-
-
Sohag, Egypt, 82511
- Recruiting
- Sohag University
-
Contact:
- Mohamed R Mohamed, MD
- Phone Number: 002 01128056501
- Email: mohamed-mourad1@med.sohag.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Every elective patient diagnosed with left-side colon or rectal cancer will be included in our study.
Exclusion Criteria:
- Unfit patients with uncontrolled medical disease will be excluded. Patients with acute intestinal obstruction (emergency cases) and patients with extremes of age above 75 or pediatric ages will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: high tie ligation of inferior mesenteric artery
Group A patients of elective operable colorectal cancer : high tie group
|
This study will include two groups of patients: group (A) and (B).
In group (A), the inferior mesenteric artery will be ligated at its origin (high-tie), While in group (B), it will be ligated after the origin of the left colic artery (low-tie).
|
|
Active Comparator: low tie ligation of inferior mesenteric artery
Group B patients of elective operable colorectal cancer : low tie group
|
This study will include two groups of patients: group (A) and (B).
In group (A), the inferior mesenteric artery will be ligated at its origin (high-tie), While in group (B), it will be ligated after the origin of the left colic artery (low-tie).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anastomotic leakage
Time Frame: 2 weeks postoperative
|
yes or no
|
2 weeks postoperative
|
|
hemorrhage
Time Frame: 2 weeks postoperative
|
yes or no
|
2 weeks postoperative
|
|
rectal cancer-low anterior resection syndrome (LARS)
Time Frame: 2 weeks postoperative
|
yes or no
|
2 weeks postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1-year overall survival
Time Frame: one year
|
yes or no
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed R Mohamed, MD, Sohag University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-24-01-01MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.