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Trial Title:
Compare Outcomes After High and Low Ligation of Inferior Mesenteric Artery in Colorectal Cancer
NCT ID:
NCT06253949
Condition:
Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
colon cancer
high tie
low tie
inferior mesenteric artery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
ligation of inferior mesenteric artery in colorectal cancer
Description:
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).
Arm group label:
high tie ligation of inferior mesenteric artery
Arm group label:
low tie ligation of inferior mesenteric artery
Summary:
We aim comparing different outcomes between high and low tie ligation of inferior
mesenteric artery in left colorectal cancer operable and elective surgeries.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
15 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sohag University
Address:
City:
Sohag
Zip:
82511
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Mohamed R Mohamed, MD
Phone:
01128056501
Phone ext:
002
Email:
mohamed-mourad1@med.sohag.edu.eg
Start date:
December 1, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06253949