Trauma InjuryNCT04327895
Surgery in Context of Terrorist Attack : a Survey of French Surgeons
An observational study of Trauma Injury and War Injury, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
The aim of the study is to assess the surgical knowledge of French Surgeons in cas of Terrorist Attack. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma Injury, War Injury, Surgical Procedure, Unspecified
- What is being tested?
- evaluation of the need for training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2018to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: French General Surgeons who are working as Resident or Licensed Surgeons in Public or Private Hospitals, and who are amenable to manage massive casualties due to Terrorist Attack
Who may be able to join
- French Licensed and Resident Surgeons
Who cannot join
- Medical Doctor, not Resident
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgery in Context of Terrorist Attack : Report of the 121st Annual Congress of French Association of Surgery
The aim of the study is to assess the surgical knowledge of French Surgeons in cas of Terrorist Attack.
Read the detailed description
Survey was sent by email to French Surgeons affiliated to French Association of General Surgeons.
First series of questions are relative to age, qualification, usual surgical practice, in order to define different "surgical profiles".
Second series of questions are relative to knowledge in the field of knowledge about trauma and massive casualties surgery.
Third series of questions are relative to the feeling of easiness in case of various situations involving severe trauma and massive casualties.
Results are analyzed in order to assess the need for learning and training in the field of trauma and massive casualties surgery.
- Conditions
- Trauma Injury, War Injury, Surgical Procedure, Unspecified
- Being tested
- evaluation of the need for training
- Keywords
- need for surgical training, surgery and terrorist attack
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of the need for trainingBehavioural
analyse of results of survey
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing the knowledge and the skills of general surgeons in the field of trauma surgery
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Nov 2018
- Primary completion1 Feb 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Collaborators
- Association Francaise de Chirurgie
- Responsible party
- Sponsor
- Investigators
- Paul R Balandraud, MD, Study director, Direction Centrale du Service de Santé des Armées
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327895
- Sponsor's protocol ID
- AFC
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery in Context of Terrorist Attack : Report of the 121st Annual Congress of French Association of Surgery
- ClinicalTrials.gov ID
- NCT04327895
- Acronym / sponsor ID
- AFC
- Conditions
- Trauma Injury, War Injury, Surgical Procedure, Unspecified
- Keywords
- need for surgical training, surgery and terrorist attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Collaborators
- Association Francaise de Chirurgie
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess the surgical knowledge of French Surgeons in cas of Terrorist Attack.
Detailed description
Survey was sent by email to French Surgeons affiliated to French Association of General Surgeons.
First series of questions are relative to age, qualification, usual surgical practice, in order to define different "surgical profiles".
Second series of questions are relative to knowledge in the field of knowledge about trauma and massive casualties surgery.
Third series of questions are relative to the feeling of easiness in case of various situations involving severe trauma and massive casualties.
Results are analyzed in order to assess the need for learning and training in the field of trauma and massive casualties surgery.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- French General Surgeons who are working as Resident or Licensed Surgeons in Public or Private Hospitals, and who are amenable to manage massive casualties due to Terrorist Attack
Key inclusion criteria (1 listed)
- French Licensed and Resident Surgeons
Key exclusion criteria (1 listed)
- Medical Doctor, not Resident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of the need for traininganalyse of results of survey | Behavioural | – |
Primary outcome
assessing the knowledge and the skills of general surgeons in the field of trauma surgery
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Individual participant dataSharing planned: No. No sharing plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul R Balandraud, MD study director
Direction Centrale du Service de Santé des Armées
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury and War Injury, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessing the knowledge and the skills of general surgeons in the field of trauma surgery (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.