Association Between Post-covid Infection Status and Perioperative Morbidity: A Ambispective Cohort Study

Completed

• Conditions: COVID-19; Complication of Anesthesia; Sars-CoV-2 Infection; Complication of Surgical Procedure; Complication,Postoperative
• Interventions: Procedure: Receiving inpatient surgical intervention

• Registration Number: NCT05689840
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

With the knowledge of currently transmitted omicron variant being less virulent, over 90 percent of the Chinese population is fully vaccinated, and the Chinese health workers have sufficient experience treating the illness. China 's epidemic prevention and control has entered a new stage to restore the normal functioning of society and basic medical services, On Dec, 7, China released a circular on further optimizing its COVID-19 response, announcing 10 new prevention and control measures.This has marked the watershed for sharply increased number of elective surgical patients diagnosed with COVID-19 during preoperativley, fully recovered or during recovery.

Beijing faced a wave of omicron infection starting that would result in of a wide range of population infections. At which time there is limited evidence regarding the optimal timing of surgery following SARS-CoV-2 infection especially for omiron among Chinsese patients .This study intends to explore the relationship between the incidence of postoperative complications after elective surgery and COVID-19 infection in Peking Union Medical College Hospital, and provide data support for the policy formulation of elective surgical timing for patients after COVID-19 infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-19
• Primary Completion: 2023-03-31
• Status Verified: 2023-05
• Study Completion: 2024-01-09
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

1. All patients having pre-operative SARS-CoV-2 infection diagnosis Dec 1st 2022 to Feb 28th 2023.

[The COVID-19 diagnosis is based on either (a) a positive RT-PCR nasopharyngeal swab, (b) positive antigen rest before surgery, or (c) clinical diagnosis made before surgery].

Exclusion Criteria

1. Patients diagnosed with SARS-CoV-2 infection on the day of surgery or during postoperative days.
2. Day surgery or outpatient surgery.
3. Patients unwilling to participate or provide COVID-19-related information.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1-2 weeks group	Receiving inpatient surgical intervention	Patients who have been infected with Covid-19 with 1-2 weeks post-COVID interval before surgery.
4-5 weeks group	Receiving inpatient surgical intervention	Patients who have been infected with Covid-19 with 4-5 weeks post-COVID interval before surgery.
0-1 week group	Receiving inpatient surgical intervention	Patients who have been infected with Covid-19 with 0-1 week post-COVID interval before surgery.
3-4 weeks group	Receiving inpatient surgical intervention	Patients who have been infected with Covid-19 with 3-4 weeks post-COVID interval before surgery.
2-3 weeks group	Receiving inpatient surgical intervention	Patients who have been infected with Covid-19 with 2-3 weeks post-COVID interval before surgery.
5-6 weeks group	Receiving inpatient surgical intervention	Patients who have been infected with Covid-19 with 5-6 weeks post-COVID interval before surgery.
over 6 weeks group	Receiving inpatient surgical intervention	Patients who have been infected with Covid-19 with over 6 weeks post-COVID interval before surgery.

Primary Outcome Measures

Name	Time	Method
Perioperative complications	During the procedure	The composite primary outcome included pulmonary complications (pneumonia, acute respiratory distress syndrome, or acute respiratory failure, reintubation, unplanned use or prolongation of postoperative mechanical ventilation), cardiovascular complications (deep vein thrombosis, pulmonary embolism, myocardial infarction, newly onset arrhythmia, ischemic stroke, and acute kidney injury), and infectious complications other than pulmonary infection (urinary tract infection, surgical site infection, and sepsis).

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China