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

NCT05677815 | Completed

• 1 other identifier: KY20232002
• Study Type: observational
• Target: 3,350
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Surgery; Postoperative Complications

Keywords

COVID-19; Postoperative Complications; Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  postoperative in-hospital or 7-day complication

Secondary Outcomes (4)

• Severe post-complications

  postoperative in-hospital or 7-day complication

• in-hospital mortality

  postoperative in-hospital or 7-day complication

• Critical care admission

  postoperative in-hospital or 7-day complication

• Duration post-operative hospital stay

  postoperative in-hospital or 7-day complication

Study Arms (2)

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

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

Procedure: Underwent Surgery from 2019 to 2022

Interventions

Underwent Surgery from 2019 to 2022 PROCEDURE

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

patients with COVID-19 infection underwent surgery in 2023; patients without COVID-19 infection underwent surgery in 2023

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who had missing primary information data (i.e., postoperative information).

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

• 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.

  PMID: 37310058 RESULT

• 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.

  PMID: 37620255 DERIVED

MeSH Terms

Conditions

COVID-19; Postoperative Complications

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chong Lei

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 10, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)