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Completed

NCT Number: NCT06197282

Impact of COVID-19 on Surgical Outcomes

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Major surgery involving general anesthesia

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.

Other names: Diagnostic Test: SAR-CoV-2 PCR nasopharyngeal swab

Primary outcomes

  1. Surgical complication rate

    Time frame: 05/05/2020-12/01/2022

    Post operative morbidity and mortality rate

Sponsors and collaborators

Lead sponsor

Kern Medical Center

Other

Registry information

Official study title

Impact of COVID-19 on Surgical Outcomes in Acute Care Service in a Community Hospital

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 9, 2024
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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