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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05689840
• Other study ID #: K23C0257
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: January 9, 2024

Study information

• Verified date: May 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: January 9, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Complication of Anesthesia
• Complication of Surgical Procedure
• Complication,Postoperative
• COVID-19
• Infections
• Postoperative Complications
• Sars-CoV-2 Infection

Intervention

Procedure:
• Receiving inpatient surgical intervention
Receiving inpatient surgical intervention in Peking Union Medical College Hospital

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay	Calculate the number of days the patient stays in the hospital.	Immediately after discharge
Other	Readmission rate during 30 days after surgery	Readmission due to surgery complications during 30 days after operation	30 days after operation
Other	Postoperative mechanical ventilation time	Length of mechanical ventilation time after surgery	During the procedure
Other	Mortality after operation	Mortality after operation in 1 month, 3 months, 6 months, 12 months	1 month, 3 months, 6 months, 12 months after operation
Other	Intraoperative respiratory complication	Intraoperative respiratory complication: a composite of intraoperative bronchospasm, poor oxygenation, and reintubation.	During the surgery
Other	the WHODisability Assessment Schedule (WHODAS 2.0)	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).	6 months after operation
Other	Brief Pain Inventory (BPI)	Brief Pain Inventory used to assess the intensity of pain	6 months after operation
Primary	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