Trial Review

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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
ACTRN12621001643864
Ethics application status
Approved
Date submitted
2/03/2021
Date registered
30/11/2021
Date last updated
30/11/2021
Date data sharing statement initially provided
30/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Perioperative outcomes after thoracic surgery
Scientific title
Retrospective perioperative database of patients undergoing thoracic surgery as part of an enhanced recovery after surgery program
Secondary ID [1] 303566 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thoracic surgery 320934 0
Perioperative complications 320935 0
Condition category
Condition code
Respiratory 318741 318741 0 0
Other respiratory disorders / diseases
Anaesthesiology 318742 318742 0 0
Pain management
Surgery 318744 318744 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This database includes the perioperative characteristics of the patients, of the surgery, the post-operative outcomes and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital outcomes for all patients undergoing thoracic surgery as part of an enhanced recovery after surgery program.
No involvment for the patients, and the medical charts will be review to gather informations needed.
- Data collection will start at tome of admission to ICU
- Data will be collected until the date of hospital discharged
- Data will be retrospectively accessed, e.g. all patients undergoing thoracic surgery at Tenon Hospital and admitted in ICU between 1/11/2018 and 31/10/2028
For each patient the follow up will continue until the date of hospital discharge.

All patients are enrolled in the enhanced recovery after surgery program wether they are involved in this study or not. It includes multiple physiotherapy session daily, early removal of catheter and chest tube, ealry refeeding, and daily activity objectives such as walking time.
Intervention code [1] 319857 0
Diagnosis / Prognosis
Comparator / control treatment
No group control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326690 0
All-cause mortality will be assess through patient medical record
Timepoint [1] 326690 0
From day of surgery until hospital discharge
Primary outcome [2] 326691 0
Postoperative respiratory complications will be assess through patient medical record
Timepoint [2] 326691 0
From day of surgery until hospital discharge
Secondary outcome [1] 392373 0
Length of stay in intensive care unit [ICU] will be assess through patient medical record
Timepoint [1] 392373 0
From day of surgery until hospital discharge
Secondary outcome [2] 392374 0
Pleural hemorrhage assessed by accessing patient medical record and documented in accordance with the Common Terminology Criteria for Adverse Events
Timepoint [2] 392374 0
From day of surgery until hospital discharge
Secondary outcome [3] 392375 0
Pulmonary infection assessed by accessing patient medical record and documented in accordance with the Common Terminology Criteria for Adverse Events
Timepoint [3] 392375 0
From day of surgery until hospital discharge
Secondary outcome [4] 392376 0
Time to ambulation in hours assessed by accessing patient medical record
Timepoint [4] 392376 0
From day of surgery until hospital discharge
Secondary outcome [5] 400541 0
Time to refeeding in hours assessed by accessing patient medical record
Timepoint [5] 400541 0
From day of surgery until hospital discharge
Secondary outcome [6] 400542 0
Time to chest tube removal in hours assessed by accessing patient medical record
Timepoint [6] 400542 0
From day of surgery until hospital discharge
Secondary outcome [7] 403559 0
Length of stay in hospital by accessing patient medical record
Timepoint [7] 403559 0
Time from hospital admission to hospital discharge

Eligibility
Key inclusion criteria
Adult (18+ years old) patients undergoing thoracic surgery with pulmonary resection and admitted in ICU
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/11/2018
Date of last participant enrolment
Anticipated
31/10/2028
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5000
Accrual to date
1300
Final
Recruitment outside Australia
Country [1] 23493 0
France
State/province [1] 23493 0
Paris

Funding & Sponsors
Funding source category [1] 307989 0
Hospital
Name [1] 307989 0
Anesthesiology Intensive Care and peri operative medicine department, Tenon hospital
Country [1] 307989 0
France
Primary sponsor type
Hospital
Name
Anesthesiology Intensive Care and peri operative medicine department, Tenon hospital
Country
France
Secondary sponsor category [1] 308711 0
None
Name [1] 308711 0
Country [1] 308711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307983 0
Commission nationale de l'informatique et des libertés
Ethics committee address [1] 307983 0
Ethics committee country [1] 307983 0
France
Date submitted for ethics approval [1] 307983 0
01/03/2016
Approval date [1] 307983 0
04/04/2016
Ethics approval number [1] 307983 0
1934112 v 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 109130 0
Dr Julien BUREY
Address 109130 0
Département d'anesthésie, réanimation et médecine péri opératoire 4 rue de la chine 75020 Paris France
Country 109130 0
France
Phone 109130 0
+33156017898
Fax 109130 0
Email 109130 0
julien.burey@aphp.fr
Contact person for public queries
Name 109131 0
Julien BUREY
Address 109131 0
Département d'anesthésie, réanimation et médecine péri opératoire 4 rue de la chine 75020 Paris France
Country 109131 0
France
Phone 109131 0
+33156017898
Fax 109131 0
Email 109131 0
julien.bureyl@aphp.fr
Contact person for scientific queries
Name 109132 0
Christophe QUESNEL
Address 109132 0
Département d'anesthésie, réanimation et médecine péri opératoire 4 rue de la chine 75020 Paris France
Country 109132 0
France
Phone 109132 0
+33156017898
Fax 109132 0
Email 109132 0
christophe.quesnel@aphp.fr

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.

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:
Immediately following publication, no end date

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 julien.burey@aphp.fr

Are there extra considerations when requesting access to individual participant data?
No


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.