NCT04684433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
707

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

December 23, 2020

Last Update Submit

March 15, 2021

Conditions

Outcome Measures

Primary Outcomes (22)

  • Surgery code

    Type of surgery as defined by the surgery code

    5 minutes

  • Urgency

    Degree of urgency of the surgery

    5 minutes

  • Type of anesthesia

    Type of anesthesia

    5 minutes

  • Delay between surgery and first symptoms

    Delay between surgery and first symptoms

    5 minutes

  • Surgery duration

    Surgery duration (anesthesia included)

    5 minutes

  • Hospital stay (in days)

    Hospital stay (in days)

    5 minutes

  • Intensive care unit stay (in days)

    Intensive care unit stay (in days)

    5 minutes

  • Post-op complications

    Post-op complications

    5 minutes

  • Covid status before surgery

    Covid status before surgery (positive=1, negative=0 )

    5 minutes

  • Covid status post-surgery

    Covid status post-op (positive=1, negative=0 )

    5 minutes

  • COVID19 Diagnosis by CT scan

    COVID19 Diagnosis confirmed by CT scan of the thorax (Yes=1, No=0)

    5 minutes

  • COVID19 Diagnosis by swab test

    COVID19 Diagnosis by swab test (Yes=1, No=0)

    5 minutes

  • COVID 19 Diagnosis by antibody test

    COVID 19 Diagnosis by antibody test (Yes=1, No=0)

    5 minutes

  • COVID19 symptoms - dry cough

    dry cough (Yes=1, No=0)

    5 minutes

  • COVID19 symptoms - fever

    fever (Yes=1, No=0)

    5 minutes

  • COVID19 symptoms - myalgia

    myalgia (Yes=1, No=0)

    5 minutes

  • COVID19 symptoms - anosmia

    anosmia (Yes=1, No=0)

    5 minutes

  • COVID19 symptoms -respiratory distress

    respiratory distress (Yes=1, No=0)

    5 minutes

  • Treatment for COVID19 - Plaquenil

    Plaquenil (Yes=1, No=0)

    5 minutes

  • Treatment for COVID19 - Antivirals

    Antivirals (Yes=1, No=0)

    5 minutes

  • Need for intubation

    Need for intubation (Yes=1, No=0)

    5 minutes

  • Death

    Mortality (Yes=1, No=0)

    5 minutes

Secondary Outcomes (5)

  • Age

    5 minutes

  • Gender

    5 minutes

  • Ethnicity

    5 minutes

  • BMI

    5 minutes

  • Comorbidities

    5 minutes

Study Arms (1)

Surgical intervention

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.

Other: Data extraction from medical files

Interventions

Data extraction from medical files

Surgical intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patient that have benefited of a surgical intervention since the start of the COVID19 pandemic in Belgium and specifically the 16 th of March 2020 (lock down) to 12 of april 2020. The involved hospitals are: Brugmann hospital, UZ Brussel Hospital, Erasme Hospital and Saint Pierre Hospital.

You may qualify if:

  • 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).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St Pierre

Brussels, 1000, Belgium

Location

CHU Brugmann

Brussels, 1020, Belgium

Location

Erasme

Brussels, 1070, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yasser Farid

    CHU Brugmann

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 24, 2020

Study Start

April 14, 2020

Primary Completion

March 15, 2021

Study Completion

March 15, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations