Impact of COVID-19 on Surgical Outcomes

NCT ID: NCT06197282

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7696 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-05
• Study Completion Date: 2022-12-01

Brief Summary

Following the introduction of the COVID-19 vaccination, elective surgeries have resumed, allowing for greater insight into the postoperative period and outcomes aims on-going COVID-19 infections. This study aimed to evaluate risk factors of postoperative morbidity and mortality in patients who had surgery within one year of testing positive for COVID-19.

Detailed Description

SARS-CoV-2 (COVID-19) has infected over 100,000,000 million people in the United States (US). During the "first wave" in the US, medical facilities were advised to limit operative exposure, stratify operative cases by both risk and urgency and cancel elective procedures.

With over 60% of the US population considered fully vaccinated as of May of 2020, elective surgeries resumed amid periodic outbreaks allowing for continued insight into the impact of COVID-19 on the postoperative recovery process. However, relative to the volume of data on active infections, there is far less concerning the sequelae of previous infections. Therefore, the purpose of this study is to analyze a safety net hospital's experience regarding postoperative complications in patients that underwent surgical procedures requiring general anesthesia within a year of testing positive for COVID-19.

This is a retrospective study from a high-volume tertiary referral center and safety net hospital in Bakersfield, California. After approval by the Institutional Review Board, the electronic health record (EHR) was queried for all positive COVID-19 patients that underwent a surgical procedure of any kind requiring general anesthesia from 5 May 2020 to 31 December 2022. A total of 7,696 patients met inclusion criteria. 420 tested positive for COVID-19. Participants were subdivided into three study groups defined as symptomatic COVID-19 infection, asymptomatic COVID-19 infection, and COVID-19 negative control group.

Individual chart review allowed for subclassification based on symptomatology, admission status, length of admission, American Society of Anesthesiologist Physical Status Classification System (ASA), qSOFA and GCS rating along with COVID-19 and surgical complications Patients were required to have a COVID-19 diagnosis within one year of surgery. Categorical variables assessed in participants included age, sex, BMI, race, ICU or DOU stay. Post-operative complications assessed for included hospital length of stay, 30-day mortality, 30-day readmission, cardiac arrest, septic shock, acute kidney injury, acute respiratory distress syndrome, deep vein, thrombosis, pulmonary embolism, respiratory failure and pneumonia.

Statistical analysis was completed by the institution's statistician. Using Fisher extract, ANOVA, univariate and multivariate logistic regression analyses, odds ratios and p-values were obtained to evaluate for statistically significant correlations between categorical variables.

Conditions

COVID-19; Surgical Outcomes; Postoperative Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

COVID-19 Positive, Symptomatic

Patients undergoing major surgery with a documented positive COVID19 test with in 1 year of surgery and were symptomatic for COVID19 at the time of testing.

Major surgery involving general anesthesia

Intervention Type: PROCEDURE

EHR documented SAR-CoV-2 PCR nasopharyngeal swab results confirming Covid-19 status within one year of undergoing surgical procedure at Kern Medical Center.

COVID-19 Positive, Asymptomatic

Patients undergoing major surgery with a documented positive COVID19 test with in 1 year of surgery and were asymptomatic for COVID19 at the time of testing as well as at the time of surgery.

Major surgery involving general anesthesia

Intervention Type: PROCEDURE

EHR documented SAR-CoV-2 PCR nasopharyngeal swab results confirming Covid-19 status within one year of undergoing surgical procedure at Kern Medical Center.

Control: COVID-19 Negative

Patients undergoing major surgery with documented COVID19 negative testing prior to procedure.

Major surgery involving general anesthesia

Intervention Type: PROCEDURE

EHR documented SAR-CoV-2 PCR nasopharyngeal swab results confirming Covid-19 status within one year of undergoing surgical procedure at Kern Medical Center.

Interventions

Major surgery involving general anesthesia

EHR documented SAR-CoV-2 PCR nasopharyngeal swab results confirming Covid-19 status within one year of undergoing surgical procedure at Kern Medical Center.

Intervention Type: PROCEDURE

Other Intervention Names

Diagnostic Test: SAR-CoV-2 PCR nasopharyngeal swab

Eligibility Criteria

Inclusion Criteria

• Documented SAR-CoV-2 PCR nasopharyngeal swab within 1 year of major surgical intervention requiring general anesthesia

Exclusion Criteria

• Surgical procedures using solely MAC and/or local anesthesia. Additionally, percutaneous endoscopic gastrostomy tube placements were omitted.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amber Jones

Principal Investigator, DO, MPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kern Medical Center

Bakersfield, California, United States

Countries

United States

Other Identifiers

22152

Identifier Type: -

Identifier Source: org_study_id