Impact of COVID-19 on Surgical Outcomes
1 other identifier
observational
7,696
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 5, 2024
CompletedFirst Posted
Study publicly available on registry
January 9, 2024
CompletedJanuary 18, 2024
January 1, 2024
2.6 years
January 5, 2024
January 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical complication rate
Post operative morbidity and mortality rate
05/05/2020-12/01/2022
Study Arms (3)
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.
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.
Control: COVID-19 Negative
Patients undergoing major surgery with documented COVID19 negative testing prior to procedure.
Interventions
EHR documented SAR-CoV-2 PCR nasopharyngeal swab results confirming Covid-19 status within one year of undergoing surgical procedure at Kern Medical Center.
Eligibility Criteria
Participants who presented to Kern Medical Center, a high-volume tertiary referral center and safety net hospital located in Bakersfield, California between May 2020 to December 2022, who underwent a surgical procedure requiring general anesthesia. Participants were required to have a EHR documented SAR-CoV-2 PCR nasopharyngeal swab within one preoperatively. Study excludes surgical procedures using only MAC or local anesthesia as well as percutaneous endoscopic gastrostomy tube placement. A total of 7,696 patients were included, 420 tested positive for COVID-19 (7.6% were symptomatic and 4.8% were asymptomatic) and 7,276 tested negative (10.9% qualified as control).
You may qualify if:
- Documented SAR-CoV-2 PCR nasopharyngeal swab within 1 year of major surgical intervention requiring general anesthesia
You may not qualify if:
- Surgical procedures using solely MAC and/or local anesthesia. Additionally, percutaneous endoscopic gastrostomy tube placements were omitted.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kern Medical Center
Bakersfield, California, 93306, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, DO, MPH
Study Record Dates
First Submitted
January 5, 2024
First Posted
January 9, 2024
Study Start
May 5, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
January 18, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share