COVID-19NCT05689840
Association Between Post-covid Infection Status and Perioperative Morbidity: A Ambispective Cohort Study
An observational study of COVID-19 and Complication of Anesthesia, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Complication of Anesthesia, Complication of Surgical Procedure
- What is being tested?
- Receiving inpatient surgical intervention
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 9 Jan 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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].
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- COVID-19, Complication of Anesthesia, Complication of Surgical Procedure, Complication,Postoperative, Sars-CoV-2 Infection
- Being tested
- Receiving inpatient surgical intervention
- Medical subject headings
- COVID-19, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving inpatient surgical interventionProcedure or surgery
Receiving inpatient surgical intervention in Peking Union Medical College Hospital
| Study group | Role | What they receive |
|---|---|---|
| 0-1 week group | Patients who have been infected with Covid-19 with 0-1 week post-COVID interval before surgery. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Receiving inpatient surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Dec 2022
- Primary completion31 Mar 2023
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shen Le, PhD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689840
- Sponsor's protocol ID
- K23C0257
- Status last verified
- May 2023
- First submitted
- 18 Jan 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35194788COVIDSurg 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.
PubMed 34793350Quinn 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.
PubMed 36525270Bryant 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.
PubMed 36515945Che 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.
PubMed 38935110Che 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.
PubMed 37709339
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Post-covid Infection Status and Perioperative Morbidity: A Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT05689840
- Acronym / sponsor ID
- K23C0257
- Conditions
- COVID-19, Complication of Anesthesia, Complication of Surgical Procedure, Complication,Postoperative, Sars-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 0-1 week group | – | Procedure: Receiving inpatient surgical interventionPatients who have been infected with Covid-19 with 0-1 week post-COVID interval before surgery. |
| 1-2 weeks group | – | Procedure: Receiving inpatient surgical interventionPatients who have been infected with Covid-19 with 1-2 weeks post-COVID interval before surgery. |
| 2-3 weeks group | – | Procedure: Receiving inpatient surgical interventionPatients who have been infected with Covid-19 with 2-3 weeks post-COVID interval before surgery. |
| 3-4 weeks group | – | Procedure: Receiving inpatient surgical interventionPatients who have been infected with Covid-19 with 3-4 weeks post-COVID interval before surgery. |
| 4-5 weeks group | – | Procedure: Receiving inpatient surgical interventionPatients who have been infected with Covid-19 with 4-5 weeks post-COVID interval before surgery. |
| 5-6 weeks group | – | Procedure: Receiving inpatient surgical interventionPatients who have been infected with Covid-19 with 5-6 weeks post-COVID interval before surgery. |
| over 6 weeks group | – | Procedure: Receiving inpatient surgical interventionPatients who have been infected with Covid-19 with over 6 weeks post-COVID interval before surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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].
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receiving inpatient surgical interventionReceiving inpatient surgical intervention in Peking Union Medical College Hospital | Procedure or surgery | 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 |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 35194788El-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.
- Background: PubMed 34793350COVIDSurg 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.
- Background: PubMed 36525270Quinn 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.
- Background: PubMed 36515945Bryant 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.
- Derived from this study: PubMed 38935110Che 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.
- Derived from this study: PubMed 37709339Che 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shen Le, PhD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Complication of Anesthesia, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative complications (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689840, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.