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

We aim comparing different outcomes between high and low tie ligation of inferior mesenteric artery in left colorectal cancer operable and elective surgeries.

Study Overview

• Status: Recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: ligation of inferior mesenteric artery in colorectal cancer

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: Interventional
• Enrollment (Estimated): 50
• 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

• Egypt
  • 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: No

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)

Number of Arms

2

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	Procedure: ligation of inferior mesenteric artery in colorectal cancer; 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	Procedure: ligation of inferior mesenteric artery in colorectal cancer; 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	yes or no	2 weeks postoperative
hemorrhage	yes or no	2 weeks postoperative
rectal cancer-low anterior resection syndrome (LARS)	yes or no	2 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year overall survival	yes or no	one year

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Mohamed R Mohamed, MD, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: colon cancer; inferior mesenteric artery; high tie; low tie
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: Soh-Med-24-01-01MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No