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

NCT ID: NCT05689840

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-01-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0-1 week group

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

Receiving inpatient surgical intervention

Intervention Type PROCEDURE

Receiving inpatient surgical intervention in Peking Union Medical College Hospital

1-2 weeks group

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

Receiving inpatient surgical intervention

Intervention Type PROCEDURE

Receiving inpatient surgical intervention in Peking Union Medical College Hospital

2-3 weeks group

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

Receiving inpatient surgical intervention

Intervention Type PROCEDURE

Receiving inpatient surgical intervention in Peking Union Medical College Hospital

3-4 weeks group

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

Receiving inpatient surgical intervention

Intervention Type PROCEDURE

Receiving inpatient surgical intervention in Peking Union Medical College Hospital

4-5 weeks group

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

Receiving inpatient surgical intervention

Intervention Type PROCEDURE

Receiving inpatient surgical intervention in Peking Union Medical College Hospital

5-6 weeks group

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

Receiving inpatient surgical intervention

Intervention Type PROCEDURE

Receiving inpatient surgical intervention in Peking Union Medical College Hospital

over 6 weeks group

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

Receiving inpatient surgical intervention

Intervention Type PROCEDURE

Receiving inpatient surgical intervention in Peking Union Medical College Hospital

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Receiving inpatient surgical intervention

Receiving inpatient surgical intervention in Peking Union Medical College Hospital

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shen Le, PhD

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 35194788 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34793350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36525270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36515945 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38935110 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37709339 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23C0257

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.