ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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Go to the Login page, click ‘reset password’ and follow the instructions.
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Return to the Login page and enter your new password. A verification code will be sent to your email.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12620000498998

Ethics application status

Approved

Date submitted

15/04/2020

Date registered

20/04/2020

Date last updated

20/04/2020

Date data sharing statement initially provided

20/04/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Retrospective Study on surgical outcomes among surgical patients during the COVID-19 (SARS-CoV-2) Pandemic

Scientific title

Retrospective cohort study of COVID-19 infection among surgical patients after surgery

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

SARS-CoV-2 Positive

Scheduled surgery

Emergency surgery

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Surgery

Other surgery

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

incidence of Sars-COV-2 infection in patients undergoing surgery from Feburary 2020 to April 2020
No involvment for the patients, and the medical charts will be review to gather informations needed.
For each participant medical chart will be check 2 weeks after surgery or at the date of hospital discharge if their hospital stay is longer than two weeks

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Incidence of Sars-COV-2 infection during hospital stay : - positive rt-PCR or high clinical suspicion with typical parenchymal lesion

Timepoint [1]

From day of surgery until 2 weeks post operative. If hospital stay exceeds 2 weeks, it'll be assess at hospital discharge

Secondary outcome [1]

Death of surgical patients with Sars-COV-2 infection SARS-COV-2 assessment :: - positive rt-PCR or high clinical suspicion with typical parenchymal lesion

Timepoint [1]

from day of surgery until discharge or death (information will be gathered from medical chart)

Eligibility

Key inclusion criteria

Adult (18+ years old) patients undergoing surgery

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Pre operative confirmed Sars-COV-2 infection

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

22/04/2020

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

700

Accrual to date

Final

Recruitment outside Australia

Country [1]

France

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Anesthesiology Intensive Care and peri operative medicine department, Tenon hospital

Address [1]

4 rue de la Chine 75020 Paris France

Country [1]

France

Primary sponsor type

Hospital

Name

Anesthesiology Intensive Care and peri operative medicine department, Tenon hospital

Address

4 rue de la Chine
75020 Paris
France

Country

France

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comité d’éthique pour la recherche en Anesthésie-Réanimation (French IRB)

Ethics committee address [1]

74 rue Raynouard
75016 Paris
FRANCE

Ethics committee country [1]

France

Date submitted for ethics approval [1]

03/04/2020

Approval date [1]

06/04/2020

Ethics approval number [1]

IRB 00010254 -- 2020 -- 054

Summary

Brief summary

On March 11, 2020, WHO declared that the COVID-19 epidemic had become a pandemic. 

Health authorities around the word are taking measures to increase conventional hospitalization and intensive care capacity. So, the way surgery is performed have changed. Emergency surgery remains a priority, and functional surgery has to be postponed. The main question concerns oncological surgery, operate or postpone? There is probably a risk induced by the pandemic COVID 19 which must be balanced against the oncological risk linked to delay in surgery. 
A Chinese report described that cancer patients are more likely to develop infection by the virus due to their immunosuppression secondary to cancer, chemotherapy and surgery. This article also highlights that these patients are at higher risk of developing severe episodes (39% vs 8%). Patients who underwent surgery or received chemotherapy in the month before the virus appeared had a greater risk (75%) of developing a severe episode than those who did not undergo surgery or did not receive chemotherapy (43%).

The objective of our report is to share our experience of performing scheduled and urgent surgery in COVID-19 pandemic. We report the perioperative characteristics and outcome of patients in whom surgery was undertaken.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Julien BUREY

Address

Département d'anesthésie, réanimation et médecine péri opératoire 4 rue de la chine 75020 Paris France

Country

France

Phone

+33156017898

Fax

[email protected]

Contact person for public queries

Name

Julien BUREY

Address

Département d'anesthésie, réanimation et médecine péri opératoire 4 rue de la chine 75020 Paris France

Country

France

Phone

+33156017898

Fax

[email protected]

Contact person for scientific queries

Name

Christophe QUESNEL

Address

Département d'anesthésie, réanimation et médecine péri opératoire 4 rue de la chine 75020 Paris France

Country

France

Phone

+33156017898

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?

• Extracted data detailing sex, age, operation type, clinical characteristics (including symptoms/signs, blood test results, and throat swab nucleic acid), and type of surgery from electronic medical records.
Lymphocytes, Platets and haemoglobin counts after surgery were also recorded.

All the data will be shared.

What types of analyses could be done with individual participant data?

• for IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?

From:
From 1st of June 2020 to 1st of June 2021

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• On demand by emailing the Primary Sponsor
Enquiries should be directed to [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically