- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07656974
Impact of IMA Occlusion on Anastomotic Leakage
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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye), 34480
- Başakşehir Çam and Sakura City Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with a history of abdominal aorta surgery/grafting
- Patients diagnosed with vascular, autoimmune, or rheumatological diseases.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Group 1
Patients who underwent surgery for rectal cancer and have anastomotic leakage.
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Group 2
Patients who underwent surgery for rectal cancer and did not have anastomotic leakage.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The diameter of the inferior mesenteric artery
Periodo de tiempo: Preoperative
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The effect of the diameter of the inferior mesenteric artery on the leak rate was measured double-blindly by preoperative computed tomography.
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Preoperative
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Yiğit Düzköylü, Assoc. Prof., Basaksehir Cam ve Sakura State Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-98
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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