Surgery in the Time of COVID-19 Pandemic

Completed

• Conditions: Covid19
• Interventions: Other: Data extraction from medical files

• Registration Number: NCT04684433
• Lead Sponsor: Brugmann University Hospital

Brief Summary

The ongoing coronavirus disease 2019 (COVID-19) which started in China, was declared on the 11th of March as a global pandemic 2020 by the World Health Organization (WHO).

Governments around the world have introduced differing forms of lock downs since the start of the pandemic demanding citizens to confine to their homes and go out only in necessity to minimize exposure to the virus. The response was observed in the emergency departments and the number of patients who presented for non-Covid issues drastically reduced.

Hospitals activated their mass casualty management plans and have reorganized and overstretched their capacity to be able to absorb both the influx of patients with the virus and those with other conditions.

Part of that reorganization was reducing the surgical activity. The main focus was shifted to patients who are considered urgent and elective surgery were postponed. Hence only surgical emergencies were maintained. Many did not present to the emergency department for fear to contract the virus and from a sense of national and global solidarity against that pandemic.

Whereas these measures are essential to prevent the spread of the virus, it may be hypothesized that for non-Covid issues, including surgical emergencies, patients may present late to the emergency department due to fear of contracting the infection in hospital. This would delay their management and lead to a worsened symptomology on presentation requiring a more complex surgical intervention with an increased complication profile.

The investigators present initial data from four major hospitals in Belgium, characterizing surgical emergencies that were managed since the start of the pandemic and discuss the repercussion the pandemic has on management of urgent surgical patients and most likely evolution of surgery after the pandemic.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-14
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-24
• Status Verified: 2021-03
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-15
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 707

Inclusion Criteria

Patients who had a surgical procedure since the start of the lock down in Belgium due to the COVID19 pandemic (16 of March 2020 to the 12 of April 2020).

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical intervention	Data extraction from medical files	Patients who had a surgical procedure since the start of the lockdown in Belgium due to the COVID19 pandemic (16 of March 2020 to the 12 of April 2020.

Primary Outcome Measures

Name	Time	Method
COVID19 Diagnosis by CT scan	5 minutes	COVID19 Diagnosis confirmed by CT scan of the thorax (Yes=1, No=0)
Covid status post-surgery	5 minutes	Covid status post-op (positive=1, negative=0 )
Surgery code	5 minutes	Type of surgery as defined by the surgery code
Delay between surgery and first symptoms	5 minutes	Delay between surgery and first symptoms
Surgery duration	5 minutes	Surgery duration (anesthesia included)
COVID19 symptoms - myalgia	5 minutes	myalgia (Yes=1, No=0)
COVID19 symptoms -respiratory distress	5 minutes	respiratory distress (Yes=1, No=0)
Treatment for COVID19 - Plaquenil	5 minutes	Plaquenil (Yes=1, No=0)
Covid status before surgery	5 minutes	Covid status before surgery (positive=1, negative=0 )
COVID19 Diagnosis by swab test	5 minutes	COVID19 Diagnosis by swab test (Yes=1, No=0)
Treatment for COVID19 - Antivirals	5 minutes	Antivirals (Yes=1, No=0)
Need for intubation	5 minutes	Need for intubation (Yes=1, No=0)
Death	5 minutes	Mortality (Yes=1, No=0)
Urgency	5 minutes	Degree of urgency of the surgery
COVID19 symptoms - dry cough	5 minutes	dry cough (Yes=1, No=0)
COVID19 symptoms - fever	5 minutes	fever (Yes=1, No=0)
COVID19 symptoms - anosmia	5 minutes	anosmia (Yes=1, No=0)
Post-op complications	5 minutes	Post-op complications
COVID 19 Diagnosis by antibody test	5 minutes	COVID 19 Diagnosis by antibody test (Yes=1, No=0)
Type of anesthesia	5 minutes	Type of anesthesia
Hospital stay (in days)	5 minutes	Hospital stay (in days)
Intensive care unit stay (in days)	5 minutes	Intensive care unit stay (in days)

Secondary Outcome Measures

Name	Time	Method
Age	5 minutes	Patient age
Gender	5 minutes	Patient gender
BMI	5 minutes	Patient Body Mass Index
Ethnicity	5 minutes	Patient ethnicity
Comorbidities	5 minutes	Patient comorbidities

Trial Locations

Locations (4)

UZ Brussel; 🇧🇪 Brussel, Belgium

St Pierre; 🇧🇪 Brussels, Belgium

CHU Brugmann; 🇧🇪 Brussels, Belgium

Erasme; 🇧🇪 Brussels, Belgium