Cervico-Facial Surgery ENT Academic Medical and Surgical Training in FranceNCT05158790
Impact of Covid-19 on Training for ENT and Cervico-Facial Surgery Residents in France
An observational study of Cervico-Facial Surgery ENT Academic Medical and Surgical Training in France and Cervico-Facial Surgery ENT Medical Residency (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur Areas), run by University Hospital, Strasbourg, France at 6 sites in France.
Trial summary
The impact of the Covid-19 pandemic on medical education is real but little known. ENT interns were directly affected by the management of Covid-19 patients (performing surgical tracheostomies), many conferences and trainings were cancelled, their usual hospital activity deeply reshuffled. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervico-Facial Surgery ENT Academic Medical and Surgical Training in France, Cervico-Facial Surgery ENT Medical Residency (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur Areas)
- What is being tested?
- Questionnaire
- How many people
- 80 participants
- Where
- 6 sitesFrance
- Study dates
- 30 Nov 2021to 28 Feb 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ENT residents in France (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur regions) during the period from November 2019 to May 2021.
Who may be able to join
- Age > 18 years
- ENT residents in France (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur regions) during the period from November 2019 to May 2021.
- Informed of the objectives of the research and not objecting to the processing of their data
Who cannot join
- Subjects in research year, on availability, or in off-track training
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Service d'ORL et de Chirurgie Cervico-Faciale CHU Henri Mondor, APHP
Créteil, 94000
Sophie BARTHIER, MD, 33.3.6.60.24.03.39, sophiebarthier@hotmail.fr
- Recruiting
Service d'ORL et de Chirurgie Cervico-Faciale Hôpital Bicêtre, APHP
Le Kremlin-Bicêtre, 94270
Mihaela ALEXANDRU, MD, 33.3.6.50.52.28.60, mihaela.dana.alexandru@gmail.com
- Recruiting
Département d'ORL et de Chirurgie Cervico-Faciale Hôpital Gui de Chauliac, CHU de Montpellier
Montpellier, 34295
Valentin FAVIER, MD, 33.3.6.79.49.24.60, valentin_favier@hotmail.com
- Recruiting
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital Lyon Sud
Pierre-Bénite, 69310
Maxime FIEUX, MD, 33.3.6.21.61.16.43, ieux.maxime@gmail.com
- Recruiting
Service d'ORL et de Chirurgie Cervico-Faciale, CHU de Poitiers
Poitiers, 86021
Florent CARSUZAA, MD, 33.3.6.82.81.62.67, florent.carsuzaa@gmail.com
- Recruiting
Service d'ORL et de Chirurgie Cervico-Faciale Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
Léa FATH, MD, 33.3.6.15.51.64.46, lea.fath@chru-strasbourg.fr
About this study
Official title: Impact of Covid-19 on Training for Medical Residents Studying in ENT and Cervico-Facial Surgery Departments in France
The impact of the Covid-19 pandemic on medical education is real but little known.
ENT interns were directly affected by the management of Covid-19 patients (performing surgical tracheostomies), many conferences and trainings were cancelled, their usual hospital activity deeply reshuffled.
Although each student has a personal story of the impact of Covid-19 on their training, there is no doubt that the effects of Covid-19 are felt at scale. This study aims to investigate the effect of the pandemic on the medical and surgical training of ENT and Cervico-Facial Surgery interns in France from November 2019 to May 2021 (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur areas). A questionnaire will be sent by mail to ENT interns in France to assess the impact of Covid-19 on the training of ENT interns in France.
- Conditions
- Cervico-Facial Surgery ENT Academic Medical and Surgical Training in France, Cervico-Facial Surgery ENT Medical Residency (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur Areas)
- Being tested
- Questionnaire
- Keywords
- Covid 19, Head and neck surgery, Residency, Medical training
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Administration of a questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of Covid-19 on the training of ENT interns in France
Evaluate the reduction in training time (practical and theoretical) as a proportion of usual training time between 2 periods: before and during the acute phase of the pandemic from November 2019 to May
Measured: before and during the acute phase of the pandemic from November 2019 to May 2021 (ordinal categorical primary endpoint)
Secondary outcomes (3)
Assess interregional disparities in the impact of the Covid-19 crisis on ENT interns' training time.
Comparison of the reduction of time dedicated to training (practical and theoretical) between different regions of France. Percentage of time spent in the operating room, duty, on-call, DES course, IUD
Comparison of the reduction of time dedicated to training (practical and theoretical) between different regions of France. Percentage of time spent in the operating room, duty, on-call, DES course, IUD.
Measured: before and during the acute phase of the pandemic, from November 2019 to May 2021
Evaluate strategies implemented to compensate for block closure and theoretical course cancellations between waves
Descriptive qualitative analysis of the strategies implemented.
Measured: Before and during the acute phase of the pandemic, from November 2019 to May 2021
Evaluate interregional disparities in training time for ENT interns outside the Covid-19 period.
Comparison of the time dedicated to training (practical and theoretical) between different regions of France over a given period (pre-Covid19)
Measured: Before and during the acute phase of the pandemic, from November 2019 to May 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start30 Nov 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervico-Facial Surgery ENT Academic Medical and Surgical Training in FranceStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158790
- Sponsor's protocol ID
- 8476
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Covid-19 on Training for Medical Residents Studying in ENT and Cervico-Facial Surgery Departments in France
- ClinicalTrials.gov ID
- NCT05158790
- Acronym / sponsor ID
- 8476
- Conditions
- Cervico-Facial Surgery ENT Academic Medical and Surgical Training in France, Cervico-Facial Surgery ENT Medical Residency (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur Areas)
- Keywords
- Covid 19, Head and neck surgery, Residency, Medical training
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 15 Dec 2021 (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 impact of the Covid-19 pandemic on medical education is real but little known.
ENT interns were directly affected by the management of Covid-19 patients (performing surgical tracheostomies), many conferences and trainings were cancelled, their usual hospital activity deeply reshuffled.
Although each student has a personal story of the impact of Covid-19 on their training, there is no doubt that the effects of Covid-19 are felt at scale. This study aims to investigate the effect of the pandemic on the medical and surgical training of ENT and Cervico-Facial Surgery interns in France from November 2019 to May 2021 (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur areas). A questionnaire will be sent by mail to ENT interns in France to assess the impact of Covid-19 on the training of ENT interns in France.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ENT residents in France (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur regions) during the period from November 2019 to May 2021.
Key inclusion criteria (3 listed)
- Age > 18 years
- ENT residents in France (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur regions) during the period from November 2019 to May 2021.
- Informed of the objectives of the research and not objecting to the processing of their data
Key exclusion criteria (1 listed)
- Subjects in research year, on availability, or in off-track training
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 |
|---|---|---|
| QuestionnaireAdministration of a questionnaire | Other | – |
Primary outcome
To evaluate the impact of Covid-19 on the training of ENT interns in France
Time frame: before and during the acute phase of the pandemic from November 2019 to May 2021 (ordinal categorical primary endpoint)
Evaluate the reduction in training time (practical and theoretical) as a proportion of usual training time between 2 periods: before and during the acute phase of the pandemic from November 2019 to May
3 secondary outcomes
Assess interregional disparities in the impact of the Covid-19 crisis on ENT interns' training time.
Time frame: before and during the acute phase of the pandemic, from November 2019 to May 2021
Evaluate strategies implemented to compensate for block closure and theoretical course cancellations between waves
Time frame: Before and during the acute phase of the pandemic, from November 2019 to May 2021
Evaluate interregional disparities in training time for ENT interns outside the Covid-19 period.
Time frame: Before and during the acute phase of the pandemic, from November 2019 to May 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervico-Facial Surgery ENT Academic Medical and Surgical Training in France and Cervico-Facial Surgery ENT Medical Residency (Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine and Provence-Alpes-Côte d'Azur Areas), run by University Hospital, Strasbourg, France at 6 sites 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 3 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: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Léa fath, MD (33.3.88.12.64.98, lea.fath@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of Covid-19 on the training of ENT interns in France (time frame: before and during the acute phase of the pandemic from November 2019 to May 2021 (ordinal categorical primary endpoint)). 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 5 Jan 2022.