Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection

Fujian Medical University (FJMU)

Status: Active, not recruiting

Conditions: Postoperative Complications; COVID-19; Breast Cancer

Treatments: Other: Preoperative resolved COVID-19

Study type: Observational

Funder types: Other

Identifiers

NCT06319209

2024KY023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 392 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Distant metastasis
• Pregnancy-associated breast cancer
• Incomplete follow-up information

Trial design

392 participants in 2 patient groups

Preoperative resolved COVID-19

Description:

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.

Treatment:

Other: Preoperative resolved COVID-19

Preoperative COVID-19 negative

Description:

Patients undergoing limited surgery for breast cancer in our Breast Surgery Department between June and August 2022 had no history of SARS-CoV-2 infection prior to surgery. However, they were diagnosed with COVID-19 after the first tumor evaluation following surgery, which occurred at least 90 days after the surgery.