Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection
- Conditions
- Breast CancerCOVID-19Postoperative Complications
- Interventions
- Other: Preoperative resolved COVID-19
- Registration Number
- NCT06319209
- Lead Sponsor
- Fujian Medical University Union Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 392
- 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
- Distant metastasis
- Pregnancy-associated breast cancer
- Incomplete follow-up information
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Preoperative resolved COVID-19 Preoperative resolved COVID-19 Patients who had a history of SARS-CoV-2 infection prior to surgery underwent limited breast cancer operations in the Breast Surgery Department of our hospital after recovering from SARS-CoV-2 infection between January 2023 and March 2023.
- Primary Outcome Measures
Name Time Method 30-day postoperative outcomes 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
- Secondary Outcome Measures
Name Time Method 12-month postoperative outcomes Within 12 months after surgery Composite indicators (including death, pneumonia, thrombosis, cardiac complications, and unplanned hospitalization) of COVID-19-related adverse outcomes at 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) Composite indicators (including death, pneumonia, thrombosis, cardiac complications, and unplanned hospitalization) of COVID-19-related adverse outcomes at the time of the initial tumor assessment after surgery
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China