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NCT Number: NCT05689840

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

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.

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Key information

Conditions

COVID-19 Complication of Anesthesia Complication of Surgical Procedure Complication,Postoperative Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Postoperative Complications RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

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

Treatment and study plan

Receiving inpatient surgical intervention

Procedure

Receiving inpatient surgical intervention in Peking Union Medical College Hospital

Primary outcomes

  1. Perioperative complications

    Time frame: 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).

Other outcomes

  1. Length of hospital stay

    Time frame: Immediately after discharge

    Calculate the number of days the patient stays in the hospital.

  2. Readmission rate during 30 days after surgery

    Time frame: 30 days after operation

    Readmission due to surgery complications during 30 days after operation

  3. Postoperative mechanical ventilation time

    Time frame: During the procedure

    Length of mechanical ventilation time after surgery

  4. Mortality after operation

    Time frame: 1 month, 3 months, 6 months, 12 months after operation

    Mortality after operation in 1 month, 3 months, 6 months, 12 months

  5. Intraoperative respiratory complication

    Time frame: During the surgery

    Intraoperative respiratory complication: a composite of intraoperative bronchospasm, poor oxygenation, and reintubation.

  6. the WHODisability Assessment Schedule (WHODAS 2.0)

    Time frame: 6 months after operation

    • Step 1-Summing of recoded item scores within each domain.
    • Step 2-Summing of all six domain scores.
    • Step 3-Converting the summary score into a metric ranging from 0 to 100 (where 0=no disability; 100=full disability).

  7. Brief Pain Inventory (BPI)

    Time frame: 6 months after operation

    Brief Pain Inventory used to assess the intensity of pain

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 19, 2023
Registry last updated
Jan 12, 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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