- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05677815
The Effect of COVID-19 Infection on Post-operative Complications
The Effect of COVID-19 Infection on Post-operative Complications in Patients Underwent Surgery During the COVID-19 to Lift the Lockdown in China: Cohort Stdy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The outbreak of COVID-19 and its global pandemic have posed a threat to public health. The deadly virus, SARS-CoV-2, has been evolving to new, more infectious variant and other lineages with additional immune escape mutations. The highly transmissible Omicron variant has been present for around one year and has supplanted Delta as the leading strain in the global pandemic. Despite the fact that 656 million people have been infected with SARS-CoV-2 worldwide as of January 1, 2023, asymptomatic infections and mild cases account for more than 90% because of its notably declined pathogenicity.As of December 20, 2022, more than 130 sub-branches of Omicron have been imported into China, with BA.5.2 and BF.7 being the most prevalent strains.
On December 7, 2022, the State Council of China issued an announcement on further optimization of measures for preventing and controlling the COVID-19 epidemic ( easing of rigorous "zero COVID" policies). Since then, the rapid spread of COVID-19 has caused a surge of COVID-19 infections in the majority of China. As of January 6, a total of 503302 individuals have been infected. Consequently, the proportion of surgical patients with current or previous SARS-CoV-2 infections will inevitably increase within a short period of time. It has been reported that recovery from SARS-CoV-2 infection is associated with a transiently elevated risk of postoperative complications. The longer the time interval between SARS-CoV-2 infection and surgery, the lower the risk of postoperative complications. An updated recommendation suggested postponing surgery for at least seven weeks following SARS-CoV-2 infection, thereby reducing the risk of postoperative complications and 30-day mortality to baseline levels (similar risk with patients without a history of SARS-CoV-2 infection). However, these recommendations were based on limited data from the earlier Covid-19 pandemic (mostly caused by the Delta strain) in Europe and the United States It may not be feasible to generalize and apply this experience and consensus to the Chinese population and use it to guide current practice.
In this prospective cohort study, the postoperative complications will be described and compared in patients with or without Covid-19 infection. In addition, risk factors in the patients and surgical levels that are associated with an increase in postoperative morbidities and mortalities will be assessed.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chong Lei
- Phone Number: 86-18629011362
- Email: crystalleichong@126.com
Study Contact Backup
- Name: Lini Wang
- Phone Number: 86-15209234508
- Email: wangln238@163.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Underwent surgery at Xijing Hospital after the COVID-19 to lift the lockdown in China, effective as of 29th December in 2022 to 7th January in 2023.
Exclusion Criteria:
- Patients who had missing primary information data (i.e., postoperative information).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients with COVID-19 infection underwent surgery in 2023
Surgery was defined as any procedure done by a surgeon in an operating theatre under general, regional
|
Surgery was defined as any procedure done by a surgeon in an operating theatre under general, regional, or local anaesthesia
|
patients without COVID-19 infection underwent surgery in 2023
Surgery was defined as any procedure done by a surgeon in an operating theatre under general, regional
|
Surgery was defined as any procedure done by a surgeon in an operating theatre under general, regional, or local anaesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative complications
Time Frame: postoperative in-hospital or 7-day complication
|
Any postoperative in-hospital or 7-day complications, were based on the Clavien-Dindo Classified, and more than 0 grade was defined as complication.
|
postoperative in-hospital or 7-day complication
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severe post-complications
Time Frame: postoperative in-hospital or 7-day complication
|
The complications classified greater than Clavien-Dindo II were defined as severe; ie, any complications that led to a reintervention (III), a life-threatening organ dysfunction (IV), or death (V).
|
postoperative in-hospital or 7-day complication
|
in-hospital mortality
Time Frame: postoperative in-hospital or 7-day complication
|
The proportion of patients who died during hospitalization post-operatively.
|
postoperative in-hospital or 7-day complication
|
Critical care admission
Time Frame: postoperative in-hospital or 7-day complication
|
The proportion of patients who admitted to ICU post-operatively.
|
postoperative in-hospital or 7-day complication
|
Duration post-operative hospital stay
Time Frame: postoperative in-hospital or 7-day complication
|
The time from end of operation to discharge from hospital
|
postoperative in-hospital or 7-day complication
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chong Lei, Xijing Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20232002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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