Clinical trial NCT05689840: Association Between Post-covid Infection Status and Perioperative Morbidity: A Ambispective Cohort Study
Official title: Association Between Post-covid Infection Status and Perioperative Morbidity: A Ambispective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Complication of Anesthesia
Complication of Surgical Procedure
Complication,Postoperative
Sars-CoV-2 Infection
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perioperative complications
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
measure: Length of hospital stay
timeFrame: Immediately after discharge
measure: Readmission rate during 30 days after surgery
timeFrame: 30 days after operation
measure: Postoperative mechanical ventilation time
timeFrame: During the procedure
measure: Mortality after operation
timeFrame: 1 month, 3 months, 6 months, 12 months after operation
measure: Intraoperative respiratory complication
timeFrame: During the surgery
measure: the WHODisability Assessment Schedule (WHODAS 2.0)
timeFrame: 6 months after operation
measure: Brief Pain Inventory (BPI)
timeFrame: 6 months after operation
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shen Le, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.