Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection: a Matched, Longitudinal, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- 30-day postoperative outcomes
研究概览
简要总结
Perioperative SARS-CoV-2 infection significantly increases the risk of postoperative complications and mortality, while also exerting long-lasting impacts on multiple organs and systems. Due to the curtailment or cessation of non-emergency surgeries during the initial phase of the pandemic, there is a lack of evidence regarding the optimal timing and medium- to long-term postoperative outcomes of surgical intervention in breast cancer patients with prior SARS-CoV-2 infection, particularly after vaccination. We aim to investigate whether prior SARS-CoV-2 infection increases the risk of postoperative adverse outcomes in breast cancer patients and determine the optimal timing for surgical intervention during the pandemic, as well as to longitudinally assess the evolution of postoperative adverse outcomes within one year after COVID-19 and identify associated risk factors.
详细描述
This study employs a prospective cohort design with longitudinal and matched characteristics, focusing on breast cancer patients who underwent surgery after recovering from SARS-CoV-2 infection. Patients were stratified by the time of surgery relative to COVID-19 diagnosis. The Inverse Probability of Treatment Weighting (IPTW) method was used to match a control group (COVID-19 negative) based on patient, tumor, and surgical factors in order to compare composite indicators (including death, pneumonia, thrombosis, cardiac complications, and unplanned hospitalization) for evaluating the optimal timing of surgery. We investigated the longitudinal evolution of postoperative adverse outcomes and identified the relevant risk factors through logistic regression analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients who underwent surgery after recovering from SARS-CoV-2 infection
- •Breast cancer patients who had never been infected with SARS-CoV-2 before surgery
排除标准
- •Distant metastasis
- •Pregnancy-associated breast cancer
- •Incomplete follow-up information
结局指标
主要结局
30-day postoperative outcomes
时间窗: Within 30 days after surgery
Composite indicators (including death, pneumonia, thrombosis, cardiac complications, and unplanned hospitalization) of COVID-19-related adverse outcomes within 30 days after surgery
次要结局
- 12-month postoperative outcomes(Within 12 months after surgery)
- Postoperative outcomes at the time of the initial tumor assessment after surgery(The time of the initial tumor assessment after surgery (about 90 days after surgery))
研究者
Chuan Wang
Head of Department of Breast Surgery
Fujian Medical University Union Hospital