Rectal Cancer SurgeryNCT07656974
Impact of IMA Occlusion on Anastomotic Leakage
An observational study of Rectal Cancer Surgery and Anastomotic Leak Rectum, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Rectal cancer is primarily treated with surgery, including low anterior resection or ultra-low anterior resection depending on tumor characteristics. Anastomotic leakage is one of the most serious postoperative complications and is associated with increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer Surgery, Anastomotic Leak Rectum, Inferior Mesenteric Artery
- How many people
- 123 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who have undergone low/ultra-low anterior resection due to rectal cancer.
Who may be able to join
- ICD C20 Patients diagnosed with malignant neoplasm of the rectum
- Patients who have undergone laparoscopic or open surgery with low anterior resection or ultra low anterior resection due to rectal cancer
Who cannot join
- Patients with a history of abdominal aorta surgery/grafting
- Patients diagnosed with vascular, autoimmune, or rheumatological diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam and Sakura City Hospital
Istanbul, 34480
About this study
Official title: The Effect of the Degree of Inferior Mesenteric Artery Occlusion on Anastomotic Leakage After Rectal Cancer Surgery
Rectal cancer is primarily treated with surgery, including low anterior resection or ultra-low anterior resection depending on tumor characteristics. Anastomotic leakage is one of the most serious postoperative complications and is associated with increased morbidity and mortality. Established risk factors include male sex, preoperative radiotherapy, low anastomosis, advanced age, comorbidities, and vascular disease.
Atherosclerosis may contribute to anastomotic leakage by reducing blood flow and impairing tissue perfusion at the anastomotic site. The inferior mesenteric artery (IMA), a major source of blood supply to the colorectal region, may be affected by atherosclerotic narrowing or occlusion, potentially increasing the risk of postoperative leakage.
The aim of this study is to assess the degree of IMA occlusion using routine preoperative contrast-enhanced computed tomography (CT) scans obtained for rectal cancer staging and to investigate its association with anastomotic leakage after rectal cancer surgery. Identification of patients with severe IMA occlusion may help guide the selective use of protective stomas to reduce the risk of this complication.
Read the detailed description
Rectal cancer can be diagnosed either after the onset of symptoms or through screening of asymptomatic individuals. Although surgery remains the cornerstone of curative treatment, rectal cancer may be managed with local excision or radical resection depending on the clinical stage, size, and location of the tumor. In terms of radical resection, patients may undergo low anterior resection or ultra-low anterior resection.
Anastomotic leakage is a serious complication following rectal surgery and is associated with increased morbidity and mortality. Elderly patients and those with comorbidities have a higher risk of death after the occurrence of an anastomotic leak. The main risk factors for anastomotic leakage include male sex, preoperative radiotherapy, low anastomosis (less than 10 cm from the anal verge), a high burden of comorbidities, advanced age, and a history of vascular disease.
Atherosclerosis increases the risk of anastomotic leakage by causing inadequate perfusion of the anastomosis due to tissue ischemia and impaired microcirculation. When atherosclerosis develops, the intima of the arteries thickens, the vessel lumen narrows, blood flow decreases, and the vasomotor function of blood vessels is impaired. In addition, collateral circulation is reduced, thereby increasing the risk of anastomotic leakage.
The superior mesenteric artery and inferior mesenteric artery are primarily responsible for the blood supply to the colorectal region. During colorectal surgery, the normal blood flow to the bowel is disrupted and reduced, which may result in local intestinal ischemia.
The primary aim of our study is to evaluate and grade the diameter of the inferior mesenteric artery using preoperative contrast-enhanced computed tomography, a simple, rapid, and readily available imaging modality routinely performed for staging purposes in patients with rectal cancer. By identifying patients with a high degree of inferior mesenteric artery narrowing or occlusion, we aim to determine whether the creation of a protective stoma should be recommended to reduce the risk of postoperative anastomotic leakage following rectal cancer surgery.
- Keywords
- Rectal cancer surgery, Anastomotic leakage, Inferior mesenteric artery occlusion
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients who underwent surgery for rectal cancer and have anastomotic leakage. | |
| Group 2 | Patients who underwent surgery for rectal cancer and did not have anastomotic leakage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diameter of the inferior mesenteric artery
The effect of the diameter of the inferior mesenteric artery on the leak rate was measured double-blindly by preoperative computed tomography.
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 May 2025
- Primary completion1 Feb 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
- Investigators
- Yiğit Düzköylü, Assoc. Prof., Study chair, Basaksehir Cam ve Sakura State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656974
- Sponsor's protocol ID
- 2025-98
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Degree of Inferior Mesenteric Artery Occlusion on Anastomotic Leakage After Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07656974
- Acronym / sponsor ID
- 2025-98
- Keywords
- Rectal cancer surgery, Anastomotic leakage, Inferior mesenteric artery occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rectal cancer is primarily treated with surgery, including low anterior resection or ultra-low anterior resection depending on tumor characteristics. Anastomotic leakage is one of the most serious postoperative complications and is associated with increased morbidity and mortality. Established risk factors include male sex, preoperative radiotherapy, low anastomosis, advanced age, comorbidities, and vascular disease.
Atherosclerosis may contribute to anastomotic leakage by reducing blood flow and impairing tissue perfusion at the anastomotic site. The inferior mesenteric artery (IMA), a major source of blood supply to the colorectal region, may be affected by atherosclerotic narrowing or occlusion, potentially increasing the risk of postoperative leakage.
The aim of this study is to assess the degree of IMA occlusion using routine preoperative contrast-enhanced computed tomography (CT) scans obtained for rectal cancer staging and to investigate its association with anastomotic leakage after rectal cancer surgery. Identification of patients with severe IMA occlusion may help guide the selective use of protective stomas to reduce the risk of this complication.
Detailed description
Rectal cancer can be diagnosed either after the onset of symptoms or through screening of asymptomatic individuals. Although surgery remains the cornerstone of curative treatment, rectal cancer may be managed with local excision or radical resection depending on the clinical stage, size, and location of the tumor. In terms of radical resection, patients may undergo low anterior resection or ultra-low anterior resection.
Anastomotic leakage is a serious complication following rectal surgery and is associated with increased morbidity and mortality. Elderly patients and those with comorbidities have a higher risk of death after the occurrence of an anastomotic leak. The main risk factors for anastomotic leakage include male sex, preoperative radiotherapy, low anastomosis (less than 10 cm from the anal verge), a high burden of comorbidities, advanced age, and a history of vascular disease.
Atherosclerosis increases the risk of anastomotic leakage by causing inadequate perfusion of the anastomosis due to tissue ischemia and impaired microcirculation. When atherosclerosis develops, the intima of the arteries thickens, the vessel lumen narrows, blood flow decreases, and the vasomotor function of blood vessels is impaired. In addition, collateral circulation is reduced, thereby increasing the risk of anastomotic leakage.
The superior mesenteric artery and inferior mesenteric artery are primarily responsible for the blood supply to the colorectal region. During colorectal surgery, the normal blood flow to the bowel is disrupted and reduced, which may result in local intestinal ischemia.
The primary aim of our study is to evaluate and grade the diameter of the inferior mesenteric artery using preoperative contrast-enhanced computed tomography, a simple, rapid, and readily available imaging modality routinely performed for staging purposes in patients with rectal cancer. By identifying patients with a high degree of inferior mesenteric artery narrowing or occlusion, we aim to determine whether the creation of a protective stoma should be recommended to reduce the risk of postoperative anastomotic leakage following rectal cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients who underwent surgery for rectal cancer and have anastomotic leakage. |
| Group 2 | – | –Patients who underwent surgery for rectal cancer and did not have anastomotic leakage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have undergone low/ultra-low anterior resection due to rectal cancer.
Key inclusion criteria (2 listed)
- ICD C20 Patients diagnosed with malignant neoplasm of the rectum
- Patients who have undergone laparoscopic or open surgery with low anterior resection or ultra low anterior resection due to rectal cancer
Key exclusion criteria (2 listed)
- Patients with a history of abdominal aorta surgery/grafting
- Patients diagnosed with vascular, autoimmune, or rheumatological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diameter of the inferior mesenteric artery
Time frame: Preoperative
The effect of the diameter of the inferior mesenteric artery on the leak rate was measured double-blindly by preoperative computed tomography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and institutional data protection policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiğit Düzköylü, Assoc. Prof. study chair
Basaksehir Cam ve Sakura State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer Surgery and Anastomotic Leak Rectum, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jun 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diameter of the inferior mesenteric artery (time frame: Preoperative). 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 18 Jun 2026.