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

NCT05689840 | Completed DMC

• 1 other identifier: K23C0257
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Complication of Anesthesia; Complication of Surgical Procedure; Complication,Postoperative; Sars-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• Perioperative complications

  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).

  During the procedure

Other Outcomes (7)

• Length of hospital stay

  Immediately after discharge

• Readmission rate during 30 days after surgery

  30 days after operation

• Postoperative mechanical ventilation time

  During the procedure

Study Arms (7)

0-1 week group

Patients who have been infected with Covid-19 with 0-1 week post-COVID interval before surgery.

Procedure: Receiving inpatient surgical intervention

1-2 weeks group

Patients who have been infected with Covid-19 with 1-2 weeks post-COVID interval before surgery.

Procedure: Receiving inpatient surgical intervention

2-3 weeks group

Patients who have been infected with Covid-19 with 2-3 weeks post-COVID interval before surgery.

Procedure: Receiving inpatient surgical intervention

3-4 weeks group

Patients who have been infected with Covid-19 with 3-4 weeks post-COVID interval before surgery.

Procedure: Receiving inpatient surgical intervention

4-5 weeks group

Patients who have been infected with Covid-19 with 4-5 weeks post-COVID interval before surgery.

Procedure: Receiving inpatient surgical intervention

5-6 weeks group

Patients who have been infected with Covid-19 with 5-6 weeks post-COVID interval before surgery.

Procedure: Receiving inpatient surgical intervention

over 6 weeks group

Patients who have been infected with Covid-19 with over 6 weeks post-COVID interval before surgery.

Procedure: Receiving inpatient surgical intervention

Interventions

Receiving inpatient surgical intervention PROCEDURE

Receiving inpatient surgical intervention in Peking Union Medical College Hospital

0-1 week group; 1-2 weeks group; 2-3 weeks group; 3-4 weeks group; 4-5 weeks group; 5-6 weeks group; over 6 weeks group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For the part of retrospective study，the investigators intend to include patients who had pre-operative SARS-CoV-2 infection diagnosis and received inpatient surgical intervention at Peking Union Medical College Hospital from December 1, 2022 to January 8, 2023. For the part of prospective study，the investigators intend to include patients who will receive inpatient surgical intervention with pre-operative SARS-CoV-2 infection diagnosis at Peking Union Medical College Hospital from January 9, 2023 to February 28, 2023.

You may qualify if:

• \. All patients having pre-operative SARS-CoV-2 infection diagnosis Dec 1st 2022 to Feb 28th 2023.
• \[The COVID-19 diagnosis is based on either (a) a positive RT-PCR nasopharyngeal swab, (b) positive antigen rest before surgery, or (c) clinical diagnosis made before surgery\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (6)

• El-Boghdadly K, Cook TM, Goodacre T, Kua J, Denmark S, McNally S, Mercer N, Moonesinghe SR, Summerton DJ. Timing of elective surgery and risk assessment after SARS-CoV-2 infection: an update: A multidisciplinary consensus statement on behalf of the Association of Anaesthetists, Centre for Perioperative Care, Federation of Surgical Specialty Associations, Royal College of Anaesthetists, Royal College of Surgeons of England. Anaesthesia. 2022 May;77(5):580-587. doi: 10.1111/anae.15699. Epub 2022 Feb 22.

  PMID: 35194788 BACKGROUND

• COVIDSurg Collaborative. Outcomes and Their State-level Variation in Patients Undergoing Surgery With Perioperative SARS-CoV-2 Infection in the USA: A Prospective Multicenter Study. Ann Surg. 2022 Feb 1;275(2):247-251. doi: 10.1097/SLA.0000000000005310.

  PMID: 34793350 BACKGROUND

• Quinn KL, Huang A, Bell CM, Detsky AS, Lapointe-Shaw L, Rosella LC, Urbach DR, Razak F, Verma AA. Complications Following Elective Major Noncardiac Surgery Among Patients With Prior SARS-CoV-2 Infection. JAMA Netw Open. 2022 Dec 1;5(12):e2247341. doi: 10.1001/jamanetworkopen.2022.47341.

  PMID: 36525270 BACKGROUND

• Bryant JM, Boncyk CS, Rengel KF, Doan V, Snarskis C, McEvoy MD, McCarthy KY, Li G, Sandberg WS, Freundlich RE. Association of Time to Surgery After COVID-19 Infection With Risk of Postoperative Cardiovascular Morbidity. JAMA Netw Open. 2022 Dec 1;5(12):e2246922. doi: 10.1001/jamanetworkopen.2022.46922.

  PMID: 36515945 BACKGROUND

• Che L, Yu J, Jin D, Bai X, Wang Y, Zhang Y, Xu L, Shen L, Huang Y. Impact of previous COVID-19 infection on postoperative complications and functional recovery: a 1-year follow-up ambispective cohort study. Int J Surg. 2025 Jan 1;111(1):481-491. doi: 10.1097/JS9.0000000000001869.

  PMID: 38935110 DERIVED

• Che L, Yu J, Bai X, Wang Y, Zhang Y, Xu L, Shen L, Huang Y. Association between post-COVID-19 status and perioperative morbidity and mortality: protocol for an ambispective cohort study. BMJ Open. 2023 Sep 14;13(9):e074337. doi: 10.1136/bmjopen-2023-074337.

  PMID: 37709339 DERIVED

MeSH Terms

Conditions

COVID-19; Postoperative Complications

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shen Le, PhD

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 19, 2023
• Study Start: December 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: January 9, 2024
• Last Updated: January 12, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)