Compare Outcomes After High and Low Ligation of Inferior Mesenteric Artery in Colorectal Cancer

NCT ID: NCT06253949

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-12-01

Brief 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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

high tie ligation of inferior mesenteric artery

Group A patients of elective operable colorectal cancer : high tie group

Group Type: ACTIVE_COMPARATOR

ligation of inferior mesenteric artery in colorectal cancer

Intervention Type: PROCEDURE

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).

low tie ligation of inferior mesenteric artery

Group B patients of elective operable colorectal cancer : low tie group

Group Type: ACTIVE_COMPARATOR

ligation of inferior mesenteric artery in colorectal cancer

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ramadan Mohamed

Assistant Lecturer of General Surgery Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed R Mohamed, MD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

Sohag University

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed R Mohamed, MD

Role: CONTACT

mohamed_mourad1@med.sohag.edu.eg

01128056501 ext. 002

Emad A Ahmed, MD

Role: CONTACT

mohamed_mourad1@med.sohag.edu.eg

01128056501 ext. 002

Facility Contacts

Mohamed R Mohamed, MD

Role: primary

mohamed-mourad1@med.sohag.edu.eg

01128056501 ext. 002

Other Identifiers

Soh-Med-24-01-01MD

Identifier Type: -

Identifier Source: org_study_id