COVID-19 PandemicNCT05069116
The Impact of Covid 19 Pandemic on the Training of General Surgery Residents
An observational study of COVID-19 Pandemic and Educational Problems, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The educational process of general surgery residents is a very important step in every surgeon's career, which is often overlooked or neglected. The Covid-19 pandemic has inflicted deep changes in the medical activity in general and in the training process of young doctors in particular. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic, Educational Problems
- What is being tested?
- Training in surgery
- How many people
- 78 participants
- Where
- 1 siteRomania
- Study dates
- 1 Dec 2019to 1 Sep 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: general surgery resident doctors
Who may be able to join
- General surgery residents
- Above second year of residency
- Residency program in Cluj-Napoca Medical Centre
Who cannot join
- Incomplete responses to the questionnaire
- Refusal to be included in the study
Trial locations and contacts
1 site in 1 country.
Romania1 site
"Iuliu Haţieganu" University of Medicine and Pharmacy
Cluj-Napoca
About this study
The educational process of general surgery residents is a very important step in every surgeon's career, which is often overlooked or neglected. The Covid-19 pandemic has inflicted deep changes in the medical activity in general and in the training process of young doctors in particular.
Our study aims to assess the impact of the Covid-19 pandemic on the educational process of general surgery residents, through a comparative study. The responses of resident doctors at a questionnaire, in two different time periods, will be compared: pre-Covid era (December 2019) and Covid era (December 2020).
- Conditions
- COVID-19 Pandemic, Educational Problems
- Being tested
- Training in surgery
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in surgeryOther
The study evaluates the training process of general surgery residents - in classic surgery, as well as laparoscopic surgery, from hospital activity to extracurricular activities.
| Study group | Role | What they receive |
|---|---|---|
| pre-Covid era | Not described Receives: Other: Training in surgery | |
| Covid-era | Not described Receives: Other: Training in surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of the pandemic on the educational process
Active participation in the operating room (hours/day, day/week), Theoretical education (hours/week), possibilities of extracurricular training
Measured: December 2019-December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Dec 2019
- Primary completion1 Dec 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Calin Popa, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069116
- Sponsor's protocol ID
- SURG TRAINING - COVID
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Covid 19 Pandemic on the Training of General Surgery Residents
- ClinicalTrials.gov ID
- NCT05069116
- Acronym / sponsor ID
- SURG TRAINING - COVID
- Conditions
- COVID-19 Pandemic, Educational Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 6 Oct 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 educational process of general surgery residents is a very important step in every surgeon's career, which is often overlooked or neglected. The Covid-19 pandemic has inflicted deep changes in the medical activity in general and in the training process of young doctors in particular.
Our study aims to assess the impact of the Covid-19 pandemic on the educational process of general surgery residents, through a comparative study. The responses of resident doctors at a questionnaire, in two different time periods, will be compared: pre-Covid era (December 2019) and Covid era (December 2020).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-Covid era | – | Other: Training in surgery |
| Covid-era | – | Other: Training in surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- general surgery resident doctors
Key inclusion criteria (3 listed)
- General surgery residents
- Above second year of residency
- Residency program in Cluj-Napoca Medical Centre
Key exclusion criteria (2 listed)
- Incomplete responses to the questionnaire
- Refusal to be included in the study
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 |
|---|---|---|
| Training in surgeryThe study evaluates the training process of general surgery residents - in classic surgery, as well as laparoscopic surgery, from hospital activity to extracurricular activities. | Other | Covid-era, pre-Covid era |
Primary outcome
The impact of the pandemic on the educational process
Time frame: December 2019-December 2020
Active participation in the operating room (hours/day, day/week), Theoretical education (hours/week), possibilities of extracurricular training
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 28 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 Pandemic and Educational Problems, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 2 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 28 Oct 2021. 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 Romania. 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?
The impact of the pandemic on the educational process (time frame: December 2019-December 2020). 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 28 Oct 2021.