NCT07656974

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

June 16, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

Rectal cancer surgeryAnastomotic leakageInferior mesenteric artery occlusion

Outcome Measures

Primary Outcomes (1)

  • 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.

    Preoperative

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who have undergone low/ultra-low anterior resection due to rectal cancer.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with a history of abdominal aorta surgery/grafting
  • Patients diagnosed with vascular, autoimmune, or rheumatological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yiğit Düzköylü, Assoc. Prof.

    Basaksehir Cam ve Sakura State Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 18, 2026

Study Start

May 1, 2025

Primary Completion

February 1, 2026

Study Completion

May 1, 2026

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to patient confidentiality and institutional data protection policies.

Locations