Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319209
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-13
Brief Title:
Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection
Sponsor:
Fujian Medical University Union Hospital
Organization:
Fujian Medical University Union Hospital
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None