Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis: an International, Multicentre, Observational Cohort Study (CovidSurg-Cancer)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 30-day postoperative COVID-19 infection rate
研究概览
简要总结
CovidSurg-Cancer is an international, multicentre, observational cohort study designed to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.
Centres can elect to include one or more cancer types in the study, in any combination, depending on local expertise and capacity. During the pilot study, investigators should enrol patients with confirmed diagnoses of:
- Colorectal cancer
- Oesophagogastric cancer
As a rapid response study to the COVID-19 pandemic, included cancer types will evolve throughout the course of the CovidSurg-Cancer study period, for example, to include breast, liver, pancreatic, gynaecological, urological cancers, or sarcomas.
详细描述
The rapid emergence of the COVID-19 virus has led to a global impact on elective surgical care.
We have very little evidence to guide us. The magnitude and effects of these changes are uncertain. The safety of operating on patients electively with the risks of COVID-19 postoperative pneumonia is unknown.
High-quality data will allow policy planning at regional and hospital level for both this outbreak and future pandemics. CovidSurg-Cancer will run in parallel to CovidSurg (which is capturing outcomes of patients undergoing surgery for all indications with concurrent COVID-19).
The primary aim is to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.
Secondary aims include; comparison of the 30-day postoperative mortality rate in cancer surgery patients that develop COVID-19 infection versus those who do not; an exploration of the scale of resource constraints related to the COVID-19 pandemic, and their impact on outcomes of elective cancer surgery; to explore variation in the selection of patients for continuing elective cancer surgery during the COVID-19 pandemic; to evaluate the impact of the COVID-19 pandemic on treatment pathways for cancers with a decision for surgical resection with curative intent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Any centre performing elective cancer surgery
- •Inclusion Criteria (patient):
- •Adults (age ≥18 years) with a confirmed diagnosis of an included cancer type
- •Decision made for surgical management with a curative intent
排除标准
- •Surgery planned with non-curative intent
- •Planned neoadjuvant therapy without a firm date for surgery, or awaiting restaging
结局指标
主要结局
30-day postoperative COVID-19 infection rate
时间窗: 30 days
Frequency of COVID-19 infection within 30 days
次要结局
- 30-day postoperative mortality rate(30-days)
- Postoperative critical care utilisation rate in high-risk cancer surgery patients.(30-days)
- Proportion of patients with delay of greater than 4 weeks from decision for surgery to date of surgery(More than 4 weeks from decision date)
- Proportion of non-operated patients with progression to incurable disease by 3-months after decision for surgery(Up to 3-months)