The Effect of COVID-19 Infection on Post-operative Complications

NCT ID: NCT05677815

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-31

Brief 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. 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.

Conditions

COVID-19; Surgery; Postoperative Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Underwent Surgery from 2019 to 2022

Intervention Type: PROCEDURE

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

Underwent Surgery from 2019 to 2022

Intervention Type: PROCEDURE

Surgery was defined as any procedure done by a surgeon in an operating theatre under general, regional, or local anaesthesia

Interventions

Underwent Surgery from 2019 to 2022

Surgery was defined as any procedure done by a surgeon in an operating theatre under general, regional, or local anaesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chong Lei, MD & phD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chong Lei

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 37310058 (View on PubMed)

Zheng 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.

Reference Type: DERIVED

PMID: 37620255 (View on PubMed)

Other Identifiers

KY20232002

Identifier Type: -

Identifier Source: org_study_id