Colorectal Cancer in Crohn's Disease: Long Term Outcomes of Different Surgical Procedures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset.
Data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible.
The study will focus on a comparison between patients treated with total proctocolectomy (TPC) and patients treated with subtotal colectomy (STC) or segmental resection (SR).
Primary endpoints will be oncologic outcomes, postoperative morbidity and mortality. Secondary endpoints include quality of life (QoL).
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
- •All patients with a diagnosis of Crohn's disease and concomitant primary colorectal cancer who underwent surgery in an expert centre between 01/01/2010 and 01/01/2020
排除标准
- •Patients who underwent non-oncologic segmental resection will be excluded from outcome analysis.
- •Patients with known genetic colorectal cancer syndromes (eg. Familial Adenomatous Polyposis, Hereditary Non-Polyposis ColoRectal Cancer Syndrome)
结局指标
主要结局
Overall Survival
时间窗: 5 years
percentage of patients alive
disease free survival
时间窗: 5 years
percentage of patients disease free
次要结局
未报告次要终点
研究者
Giuseppe Sigismondo Sica
Associate Professor, Head of Department
University of Rome Tor Vergata