- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Istanbul, 터키 (Türkiye), 34480
- Basaksehir Cam and Sakura City Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The diameter of the inferior mesenteric artery
기간: 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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공동 작업자 및 조사자
수사관
- 연구 의자: Yiğit Düzköylü, Assoc. Prof., Basaksehir Cam ve Sakura State Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-98
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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-
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