Impact of the Coronavirus Disease 2019 Pandemic on Oncologic Outcomes in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14,951
- 试验地点
- 1
- 主要终点
- stage distribution in patients who underwent CRC surgery during the pre-COVID-19 period, compared with those who underwent the surgery during the COVID-19 period.
研究概览
简要总结
The goal of this observational study is to assess the impact of the COVID-19 pandemic on colorectal cancer (CRC) outcomes, particularly focusing on stage distribution and recurrence-free survival in patients undergoing surgery at eight tertiary care institutions in Korea from 2018 to 2020.
Main Question Does the COVID-19 pandemic lead to more advanced stages of colorectal cancer at diagnosis and higher complication rates during surgery? Is there a significant difference in recurrence-free survival between CRC patients treated before and during the pandemic?
This study found that more patients presented with advanced-stage CRC during the COVID-19 pandemic, with significantly higher rates of tumor-related complications (perforations, abscesses, and preoperative obstructions), as well as an increase in open surgeries and combined resections.
No significant difference in recurrence-free survival was observed between the pre-COVID-19 and COVID-19 periods, although postoperative complication rates were higher, especially among rectal cancer patients and those receiving preoperative chemoradiotherapy.
详细描述
This observational, population-based, cohort study was conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. It was approved by the regional ethics committee in the Republic of Korea and institutional review boards of the eight participating institutions. Due to the anonymity of the data, the requirement for informed consent was waived.
The study timeline was determined by the phased social distancing measures implemented in the Republic of Korea in response to the COVID-19 pandemic. The study focused on patients with CRC who underwent surgical treatment from 2018 to 2020. The pre-COVID-19 period extended from 2018 to February 2020, and the COVID-19 period began in March 2020 with the identification of the first COVID-19 case in the Republic of Korea and subsequent government measures to prevent the spread of the disease.
Eight institutions across the Republic of Korea participated in the study, including Asan Medical Center, Seoul St. Mary's Hospital, Korea University Anam Hospital, Samsung Medical Center, Pusan National University Yangsan Hospital, Gangnam Severance Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. These institutions are tertiary medical centers, varying in location and size.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with colorectal cancer who underwent surgery
- •in 8 institution including Asan Medical Center, Seoul St. Mary's Hospital, Korea University Anam Hospital, Samsung Medical Center, Pusan National University Yangsan Hospital, Gangnam Severance Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital
排除标准
- •Familial adenomatous polyposis (FAP)
- •Hereditary non-polyposis colon cancer (HNPCC)
- •Cancer associated with inflammatory bowel disease (IBD)
- •Colorectal cancer not proven on biopsy, and pathologies other than adenocarcinoma.
- •Emergency operation
结局指标
主要结局
stage distribution in patients who underwent CRC surgery during the pre-COVID-19 period, compared with those who underwent the surgery during the COVID-19 period.
时间窗: At the time the biopsy results were available for patients who underwent surgery between 2018 and 2020 (7 days after surgery).
We aimed to document the pathological stage for each patient based on the biopsy results after surgery and analyze how the stage distribution differed between the pre-COVID and COVID groups.
次要结局
- 2-year recurrence free survival (RFS) and surgical complication rate in patients who underwent CRC surgery during the pre-COVID-19 period, compared with those who underwent the surgery during the COVID-19 period.(Outcome measures will be assessed at 2 years post-surgery.)
研究者
In Ja Park
Professor
Asan Medical Center