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Colon CancerNCT06253949

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

A study testing ligation of inferior mesenteric artery in colorectal cancer in people with Colon Cancer, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 15 to 75 years
Conditions the study is for
Colon Cancer
What is being tested?
ligation of inferior mesenteric artery in colorectal cancer
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Dec 2023to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Every elective patient diagnosed with left-side colon or rectal cancer will be included in our study.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Sohag University

    Sohag, 82511

    Mohamed R Mohamed, MD, 01128056501 ext. 002, mohamed-mourad1@med.sohag.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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
Being tested
ligation of inferior mesenteric artery in colorectal cancer
Keywords
colon cancer, high tie, low tie, inferior mesenteric artery
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ligation of inferior mesenteric artery in colorectal cancerProcedure or surgery

    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).

Study groups in NCT06253949
Study groupRoleWhat they receive
high tie ligation of inferior mesenteric arteryActive comparatorGroup A patients of elective operable colorectal cancer : high tie group
Receives: Procedure: ligation of inferior mesenteric artery in colorectal cancer
low tie ligation of inferior mesenteric arteryActive comparatorGroup B patients of elective operable colorectal cancer : low tie group
Receives: Procedure: ligation of inferior mesenteric artery in colorectal cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. anastomotic leakage

    yes or no

    Measured: 2 weeks postoperative

  2. hemorrhage

    yes or no

    Measured: 2 weeks postoperative

  3. rectal cancer-low anterior resection syndrome (LARS)

    yes or no

    Measured: 2 weeks postoperative

Secondary outcomes (1)
  1. 1-year overall survival

    yes or no

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start1 Dec 2023
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06253949
Sponsor's protocol ID
Soh-Med-24-01-01MD
Status last verified
Feb 2024
First submitted
4 Feb 2024
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: not yet decided

Questions about this trial

What is this clinical trial studying?

A study testing ligation of inferior mesenteric artery in colorectal cancer in people with Colon Cancer, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed R Mohamed, MD (01128056501 ext. 002, mohamed_mourad1@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

anastomotic leakage (time frame: 2 weeks postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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