Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 615
- 试验地点
- 12
- 主要终点
- Total calcification score associated with the occurrence of anastomotic leakage
研究概览
简要总结
Anastomotic leakage is the major postoperative complication in right colectomy. Evaluation of calcification on coeliac trunk and mesenteric arteries on the preoperative CT scan could allow the identification of patient at-risk of postoperative complications.
A monocentric retrospective study performed at CHD Vendée concluded than a calcification score over or equal to 3 was associated with a higher risk of developping an anastomotic leakage.
The aim of this prospective multicentric study is to validate a calcification score based on preoperative CT scan analysis and focussing at coeliac trunk and mesenteric arteries.This study will involve patients operated on with a scheduled right colectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Scheduled right colectomy with restoration of digestive continuity
- •Patient who has had or will have a preoperative abdominal-pelvic CT scan with or without contrast injection
- •Patient with the ability to understand the protocol and agree to participate in the study.
- •Affiliated with a social security system
排除标准
- •Patient requiring a right colectomy or ileocaecal resection for chronic inflammatory bowel disease or on long-term corticosteroid therapy
- •Patient with a history of colic resection
- •Patient under guardianship, curatorship, or deprived of liberty
- •Pregnant, postpartum or breastfeeding women
- •Minor patients
结局指标
主要结局
Total calcification score associated with the occurrence of anastomotic leakage
时间窗: 6 weeks after surgery
Sum of the calcification scores of the following 4 segments (≥3) associated with the occurrence of anastomotic leakage within 6 weeks postoperatively. 4 segments: * Ostium of celiac artery * Ostium of superior mesenteric artery * first segment of superior mesenteric artery * distal segment of superior mesenteric artery Each segment will be assigned a score between 0 and 2. Total score range : 0-8
次要结局
- Morbidities defined according to Clavien-Dindo classification(6 weeks after surgery)
- Calcification score of each segment associated with the occurrence of anastomotic leakage(6 weeks after surgery)