COVIDNCT04338945
Impact of Pandemic COVID-19 on Surgical Specialities Residents in Italy
An observational study of COVID, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 7 sites in Italy.
Trial summary
The Coronavirus Emergency has severely affected Italian Healthcare National System. This event made it necessary to adopt extraordinary containment measures and to allocate extraordinary resources in Italian hospitals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID
- What is being tested?
- COVID-surgRES questionaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 7 sitesItaly
- Study dates
- 15 Mar 2020to 1 May 2020
- 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: Italian medical residents in surgical areas
Who may be able to join
- Residents in the following surgical specialities: cardiothoracic surgery, colon and rectal surgery, general surgery, gynecology and obstetrics, gynecologic oncology, neurological surgery, ophthalmic surgery, oral and maxillofacial surgery, orthopaedic surgery, otorhinolaryngology, pediatric surgery, plastic and maxillofacial surgery, urology, and vascular surgery
Who cannot join
- Undergratuated and postgraduated students
- Consultants in surgical areas
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
U.O.C. Chirurgia Generale Universitaria "V. Bonomo"
Bari
Ospedale Perrino Asl Brindisi
Brindisi
Dipartimento di scienze mediche e chirurgiche, Università di Catanzaro
Catanzaro
Ospedale Policlinico San Martino
Genova
Azienda Ospedaliera San Camillo-Forlanini
Roma
IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Roma
Ospedale Cristo re
Roma
About this study
Official title: Impact of Pandemic COVID-19 on Surgical Specialities Residents in Italy: an Italian Polispecialistic Society of Young Surgeons (S.P.I.G.C.) Survey
The Coronavirus Emergency has severely affected Italian Healthcare National System. This event made it necessary to adopt extraordinary containment measures and to allocate extraordinary resources in Italian hospitals. In many centers routinely elective surgical activity has been decreased or even completely abolished. We believe that this exceptional condition is being consequently having a significant impact on surgical training programs.
Read the detailed description
Purpose of this investigation, organized by the Italian Polispecialistic Society of Young Surgeons (S.P.I.G.C.), is to establish the impact of COVID-19 emergency in the work and training activities of Italian surgical residents.
There will be collected the residents' impressions by completing a survey on this topic. A sub-analysis for each pandemic wave (first, second, third) will be done.
- Conditions
- COVID
- Being tested
- COVID-surgRES questionaire
- Keywords
- resident wellness, surgical residency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-surgRES questionaireBehavioural
The questionaire gives a multidimensional assessment of residents' impression with regard to impact of COVID emergency on Italian specialist training programs
| Study group | Role | What they receive |
|---|---|---|
| Residents in surgical areas | Not described Receives: Behavioral: COVID-surgRES questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the impact of first wave of COVID Pandemic on surgical specialist training programs
Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers
Measured: 1-3 months after the beginning of COVID emergency in Italy
Measure of the impact of second wave of COVID Pandemic on surgical specialist training programs
Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers
Measured: 1 year after the beginning of COVID emergency in Italy
Measure of the impact of third wave of COVID Pandemic on surgical specialist training programs
Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers
Measured: 2 years after the beginning of COVID emergency in Italy
Secondary outcomes (3)
Measure of impact of first wave of COVID Pandemic on wellness of residents
Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers
Measured: 1-3 months after the beginning of COVID emergency in Italy
Measure of impact of second wave of COVID Pandemic on wellness of residents
Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers
Measured: 1 year after the beginning of COVID emergency in Italy
Measure of impact of third wave of COVID Pandemic on wellness of residents
Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers
Measured: 2 years after the beginning of COVID emergency in Italy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start15 Mar 2020
- Primary completion15 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338945
- Sponsor's protocol ID
- COVID-ItaliansurgRES-SPIGC
- Status last verified
- Mar 2022
- First submitted
- 7 Apr 2020
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pandemic COVID-19 on Surgical Specialities Residents in Italy: an Italian Polispecialistic Society of Young Surgeons (S.P.I.G.C.) Survey
- ClinicalTrials.gov ID
- NCT04338945
- Acronym / sponsor ID
- COVID-ItaliansurgRES-SPIGC
- Conditions
- COVID
- Keywords
- resident wellness, surgical residency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e OstetriciaUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 8 Apr 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 Coronavirus Emergency has severely affected Italian Healthcare National System. This event made it necessary to adopt extraordinary containment measures and to allocate extraordinary resources in Italian hospitals. In many centers routinely elective surgical activity has been decreased or even completely abolished. We believe that this exceptional condition is being consequently having a significant impact on surgical training programs.
Detailed description
Purpose of this investigation, organized by the Italian Polispecialistic Society of Young Surgeons (S.P.I.G.C.), is to establish the impact of COVID-19 emergency in the work and training activities of Italian surgical residents.
There will be collected the residents' impressions by completing a survey on this topic. A sub-analysis for each pandemic wave (first, second, third) will be done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Residents in surgical areas | – | Behavioral: COVID-surgRES questionaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Italian medical residents in surgical areas
Key inclusion criteria (1 listed)
- Residents in the following surgical specialities: cardiothoracic surgery, colon and rectal surgery, general surgery, gynecology and obstetrics, gynecologic oncology, neurological surgery, ophthalmic surgery, oral and maxillofacial surgery, orthopaedic surgery, otorhinolaryngology, pediatric surgery, plastic and maxillofacial surgery, urology, and vascular surgery
Key exclusion criteria (2 listed)
- Undergratuated and postgraduated students
- Consultants in surgical areas
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 |
|---|---|---|
| COVID-surgRES questionaireThe questionaire gives a multidimensional assessment of residents' impression with regard to impact of COVID emergency on Italian specialist training programs | Behavioural | Residents in surgical areas |
Primary outcome
Measure of the impact of first wave of COVID Pandemic on surgical specialist training programs
Time frame: 1-3 months after the beginning of COVID emergency in Italy
Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers
Measure of the impact of second wave of COVID Pandemic on surgical specialist training programs
Time frame: 1 year after the beginning of COVID emergency in Italy
Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers
Measure of the impact of third wave of COVID Pandemic on surgical specialist training programs
Time frame: 2 years after the beginning of COVID emergency in Italy
Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers
3 secondary outcomes
Measure of impact of first wave of COVID Pandemic on wellness of residents
Time frame: 1-3 months after the beginning of COVID emergency in Italy
Measure of impact of second wave of COVID Pandemic on wellness of residents
Time frame: 1 year after the beginning of COVID emergency in Italy
Measure of impact of third wave of COVID Pandemic on wellness of residents
Time frame: 2 years after the beginning of COVID emergency in Italy
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 17 Mar 2022.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 7 sites in Italy.
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 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 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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?
Measure of the impact of first wave of COVID Pandemic on surgical specialist training programs (time frame: 1-3 months after the beginning of COVID emergency in Italy). The study lists 3 primary outcomes in all. 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 17 Mar 2022.