NCT06528054尚未招募不适用
TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection: the TENTACLE - Colon Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 主要终点
- 90-day mortality
研究概览
简要总结
This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives:
- To identify predictive factors associated with 90-day mortality and 90-day Clavien-Dindo grade 4-5 complications amongst patients who developed AL following colon cancer resection and to develop and validate a prediction model for predicting 90-day mortality as well as the co-primary composite endpoint Clavien-Dindo grade 4-5 complications.
- To explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, considering patient, tumour, resection and leakage characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
90-day mortality
时间窗: 90 days after colon cancer resection
mortality correlated with anastomotic leakage
90-day Clavien-Dindo grade IV - V complications
时间窗: 90 days after colon cancer resection
This composite co-primary outcome consists of single-organ failure (i.e. grade IV) and mortality (i.e. grade V)
次要结局
- Length of hospital/intensive care unit stay(at least one year follow up)
- Mortality(30-day, 90-day and one-year after colon cancer resection)
- Time from colon cancer resection to diagnosis of anastomotic leakage(at least one year follow up)
- Stoma presence (and if so, type of stoma)(At least one year after colon cancer resection, preferably last date of follow up)
- Disease status(At least one year after colon cancer resection, preferably at last date of follow up)
- Time from colon cancer resection to primary treatment of anastomotic leakage(at least one year follow up)
- Number of radiologic and surgical reinterventions(One year after colon cancer resection)
研究者
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