COVID-19NCT05677815
The Effect of COVID-19 Infection on Post-operative Complications
An observational study of COVID-19 and Surgery, run by Xijing Hospital at 1 site in China.
Trial summary
We did an multi-centre, observational cohort study in patients who had surgery in 2023. We included participants who underwent surgery after the COVID-19 to lift the lockdown in China. Patients meeting the same criteria were eligible who had been treated during the same calendar period of 2019 through 2021. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Surgery, Postoperative Complications
- What is being tested?
- Underwent Surgery from 2019 to 2022
- Type of treatment
- Surgery or procedure
- How many people
- 3,350 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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: The exposure of interest was a diagnosis of COVID-19 viral infection defined using the the process of experiencing typical COVID-19 symptoms, or swab-test positive (either PCR or rapid antigen SARS-CoV-2 test). Patients with COVID-19 were categorised as symptomatic if they had concomitant respiratory illness or indicating respiratory support.
Who may be able to join
- 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.
Who cannot join
- Patients who had missing primary information data (i.e., postoperative information).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
We did an multi-centre, observational cohort study in patients who had surgery in 2023. We included participants who underwent surgery after the COVID-19 to lift the lockdown in China. Patients meeting the same criteria were eligible who had been treated during the same calendar period of 2019 through 2021. The primary outcomes were the post-operative in-hospital complications. We hypothesized that the post-operative in-hospital complications during the COVID-19 to lift the lockdown period in China were different to complications for the same kind of patients during the same calendar period of the previous years.
Read the 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.
- Conditions
- COVID-19, Surgery, Postoperative Complications
- Being tested
- Underwent Surgery from 2019 to 2022
- Keywords
- COVID-19, Postoperative Complications, Surgery
- 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.
Underwent Surgery from 2019 to 2022Procedure or surgery
Surgery was defined as any procedure done by a surgeon in an operating theatre under general, regional, or local anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Underwent Surgery from 2019 to 2022 | |
| 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 Receives: Procedure: Underwent Surgery from 2019 to 2022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications
Any postoperative in-hospital or 7-day complications, were based on the Clavien-Dindo Classified, and more than 0 grade was defined as complication.
Measured: postoperative in-hospital or 7-day complication
Secondary outcomes (4)
Severe post-complications
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).
Measured: postoperative in-hospital or 7-day complication
in-hospital mortality
The proportion of patients who died during hospitalization post-operatively.
Measured: postoperative in-hospital or 7-day complication
Critical care admission
The proportion of patients who admitted to ICU post-operatively.
Measured: postoperative in-hospital or 7-day complication
Duration post-operative hospital stay
The time from end of operation to discharge from hospital
Measured: postoperative in-hospital or 7-day complication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Xijing 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
- Prospective
- Enrolment
- 3,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
- Investigators
- Chong Lei, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677815
- Sponsor's protocol ID
- KY20232002
- Status last verified
- Apr 2025
- First submitted
- 8 Jan 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang L, Zheng Z, Zhu S, Luo G, Gao B, Ma Y, Xu S, Dong H, Lei C. Changes in early postoperative outcomes and complications observed in a single center during the 2022 COVID-19 pandemic wave in China: A single-center ambispective cohort study. Chin Med J (Engl). 2023 Jul 20;136(14):1708-1718. doi: 10.1097/CM9.0000000000002724. Epub 2023 Jun 15.
PubMed 37310058Zheng Z, Gao B, Luo G, Wang L, Lei C. Impact of SARS-CoV-2 infection on postoperative complications of patients undergoing surgery after general outbreak in China: a protocol for multicentre prospective cohort study. BMJ Open. 2023 Aug 24;13(8):e072608. doi: 10.1136/bmjopen-2023-072608.
PubMed 37620255
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05677815
- Acronym / sponsor ID
- KY20232002
- Conditions
- COVID-19, Surgery, Postoperative Complications
- Keywords
- COVID-19, Postoperative Complications, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,350 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 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.
We did an multi-centre, observational cohort study in patients who had surgery in 2023. We included participants who underwent surgery after the COVID-19 to lift the lockdown in China. Patients meeting the same criteria were eligible who had been treated during the same calendar period of 2019 through 2021. The primary outcomes were the post-operative in-hospital complications. We hypothesized that the post-operative in-hospital complications during the COVID-19 to lift the lockdown period in China were different to complications for the same kind of patients during the same calendar period of the previous years.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with COVID-19 infection underwent surgery in 2023 | – | Procedure: Underwent Surgery from 2019 to 2022Surgery was defined as any procedure done by a surgeon in an operating theatre under general, regional |
| patients without COVID-19 infection underwent surgery in 2023 | – | Procedure: Underwent Surgery from 2019 to 2022Surgery was defined as any procedure done by a surgeon in an operating theatre under general, regional |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The exposure of interest was a diagnosis of COVID-19 viral infection defined using the the process of experiencing typical COVID-19 symptoms, or swab-test positive (either PCR or rapid antigen SARS-CoV-2 test). Patients with COVID-19 were categorised as symptomatic if they had concomitant respiratory illness or indicating respiratory support.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who had missing primary information data (i.e., postoperative 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 |
|---|---|---|
| Underwent Surgery from 2019 to 2022Surgery was defined as any procedure done by a surgeon in an operating theatre under general, regional, or local anaesthesia | Procedure or surgery | patients with COVID-19 infection underwent surgery in 2023, patients without COVID-19 infection underwent surgery in 2023 |
Primary outcome
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.
4 secondary outcomes
Severe post-complications
Time frame: postoperative in-hospital or 7-day complication
in-hospital mortality
Time frame: postoperative in-hospital or 7-day complication
Critical care admission
Time frame: postoperative in-hospital or 7-day complication
Duration post-operative hospital stay
Time frame: postoperative in-hospital or 7-day complication
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 6 Apr 2025.
- Results publication: PubMed 37310058Wang L, Zheng Z, Zhu S, Luo G, Gao B, Ma Y, Xu S, Dong H, Lei C. Changes in early postoperative outcomes and complications observed in a single center during the 2022 COVID-19 pandemic wave in China: A single-center ambispective cohort study. Chin Med J (Engl). 2023 Jul 20;136(14):1708-1718. doi: 10.1097/CM9.0000000000002724. Epub 2023 Jun 15.
- Derived from this study: PubMed 37620255Zheng Z, Gao B, Luo G, Wang L, Lei C. Impact of SARS-CoV-2 infection on postoperative complications of patients undergoing surgery after general outbreak in China: a protocol for multicentre prospective cohort study. BMJ Open. 2023 Aug 24;13(8):e072608. doi: 10.1136/bmjopen-2023-072608.
- 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.
Chong Lei principal investigator
Xijing 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 Surgery, run by Xijing 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 1 inclusion and 1 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 6 Apr 2025. 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?
Post-operative complications (time frame: postoperative in-hospital or 7-day complication). 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 NCT05677815, which also lists 2 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 6 Apr 2025.