- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Istanbul, Tyrkia (Türkiye), 34480
- Başakşehir Çam and Sakura City Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The diameter of the inferior mesenteric artery
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Yiğit Düzköylü, Assoc. Prof., Basaksehir Cam ve Sakura State Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-98
Plan for individuelle deltakerdata (IPD)
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