Surgery and covid19ALIGHIERINCT04824664
The ALIGHIERI Survey: an Italian Overview of Global Impact of tHe COVID-19 pandemIc on General surgERy practIce
An observational study of Surgery and covid19, run by Associazione Chirurghi Ospedalieri Italiani at 1 site in Italy.
Trial summary
Introduction The present survey aimed to provide a comprehensive overview of the Italian scenario concerning general surgery during the first wave COVID-19 outbreak and evaluate the experiences, trends, attitudes, and possible educational outcomes that this emergency brought to light. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery and covid19
- What is being tested?
- survey
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 30 Dec 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: all Italian general surgeon
Who may be able to join
- alla surgeon in activity
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Introduction The present survey aimed to provide a comprehensive overview of the Italian scenario concerning general surgery during the first wave COVID-19 outbreak and evaluate the experiences, trends, attitudes, and possible educational outcomes that this emergency brought to light. Material and Methods A 31-item survey was designed and edited by the scientific board of the ACOI (Associazione Chirurghi Ospedalieri Italiani), addressing the impact of the pandemic outbreak on surgical staff and activity during the period from March 9 to May 30, 2020 (phase 1, lockdown period) and addressing the status of surgical activity, staff, and surgery resumption in the period from June 1 to September 30, 2020 (phase 3, restart). The survey was distributed via email and social media to Italian general surgeon working both in COVID-19 and non-COVID-19 hospitals. R
Read the detailed description
Introduction The present survey aimed to provide a comprehensive overview of the Italian scenario concerning general surgery during the first wave COVID-19 outbreak and evaluate the experiences, trends, attitudes, and possible educational outcomes that this emergency brought to light. Material and Methods A 31-item survey was designed and edited by the scientific board of the ACOI (Associazione Chirurghi Ospedalieri Italiani), addressing the impact of the pandemic outbreak on surgical staff and activity during the period from March 9 to May 30, 2020 (phase 1, lockdown period) and addressing the status of surgical activity, staff, and surgery resumption in the period from June 1 to September 30, 2020 (phase 3, restart). The survey was distributed via email and social media to Italian general surgeon working both in COVID-19 and non-COVID-19 hospitals. .
- Conditions
- Surgery and covid19
- Being tested
- survey
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
survey among surgeon
What is being measured
The primary outcome is the main question the study is designed to answer.
surgery volume during covid19 lockdown
number of surgical procedure performed all over italy during covid19 first lockdown
Measured: 8months
Secondary outcomes (1)
surgery volume after the first covid19 lockdown
number of surgical procedure performed all over italy during re start period
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jan 2020
- Primary completion30 Jul 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgery and covid19Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associazione Chirurghi Ospedalieri Italiani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Fransvea, Associazione Chirurghi Ospedalieri Italiani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824664
- Sponsor's protocol ID
- Survey_ACOI_COVID19
- Acronym
- ALIGHIERI
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Cozza V, Fransvea P, La Greca A, De Paolis P, Marini P, Zago M, Sganga G; I.-ACTSS.-COVID19 Collaborative Study Group. I-ACTSS-COVID-19-the Italian acute care and trauma surgery survey for COVID-19 pandemic outbreak. Updates Surg. 2020 Jun;72(2):297-304. doi: 10.1007/s13304-020-00832-4. Epub 2020 Jun 24.
PubMed 32583216Fransvea P, Sganga G, Cozza V, Di Grezia M, Fico V, Tirelli F, Pepe G, La Greca A. Set up of a dedicated COVID-19 surgical pathway and operating room for surgical emergencies. J Trauma Acute Care Surg. 2020 Oct;89(4):e97-e100. doi: 10.1097/TA.0000000000002852. No abstract available.
PubMed 33017138
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ALIGHIERI Survey: an Italian Overview of Global Impact of tHe COVID-19 pandemIc on General surgERy practIce
- ClinicalTrials.gov ID
- NCT04824664
- Acronym / sponsor ID
- ALIGHIERI / Survey_ACOI_COVID19
- Conditions
- Surgery and covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Associazione Chirurghi Ospedalieri ItalianiUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 1 Apr 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.
Introduction The present survey aimed to provide a comprehensive overview of the Italian scenario concerning general surgery during the first wave COVID-19 outbreak and evaluate the experiences, trends, attitudes, and possible educational outcomes that this emergency brought to light. Material and Methods A 31-item survey was designed and edited by the scientific board of the ACOI (Associazione Chirurghi Ospedalieri Italiani), addressing the impact of the pandemic outbreak on surgical staff and activity during the period from March 9 to May 30, 2020 (phase 1, lockdown period) and addressing the status of surgical activity, staff, and surgery resumption in the period from June 1 to September 30, 2020 (phase 3, restart). The survey was distributed via email and social media to Italian general surgeon working both in COVID-19 and non-COVID-19 hospitals. R
Detailed description
Introduction The present survey aimed to provide a comprehensive overview of the Italian scenario concerning general surgery during the first wave COVID-19 outbreak and evaluate the experiences, trends, attitudes, and possible educational outcomes that this emergency brought to light. Material and Methods A 31-item survey was designed and edited by the scientific board of the ACOI (Associazione Chirurghi Ospedalieri Italiani), addressing the impact of the pandemic outbreak on surgical staff and activity during the period from March 9 to May 30, 2020 (phase 1, lockdown period) and addressing the status of surgical activity, staff, and surgery resumption in the period from June 1 to September 30, 2020 (phase 3, restart). The survey was distributed via email and social media to Italian general surgeon working both in COVID-19 and non-COVID-19 hospitals. .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all Italian general surgeon
Key inclusion criteria (1 listed)
- alla surgeon in activity
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| surveysurvey among surgeon | Other | – |
Primary outcome
surgery volume during covid19 lockdown
Time frame: 8months
number of surgical procedure performed all over italy during covid19 first lockdown
1 secondary outcome
surgery volume after the first covid19 lockdown
Time frame: 3 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 1 Apr 2021.
- Background: PubMed 32583216Cozza V, Fransvea P, La Greca A, De Paolis P, Marini P, Zago M, Sganga G; I.-ACTSS.-COVID19 Collaborative Study Group. I-ACTSS-COVID-19-the Italian acute care and trauma surgery survey for COVID-19 pandemic outbreak. Updates Surg. 2020 Jun;72(2):297-304. doi: 10.1007/s13304-020-00832-4. Epub 2020 Jun 24.
- Results publication: PubMed 33017138Fransvea P, Sganga G, Cozza V, Di Grezia M, Fico V, Tirelli F, Pepe G, La Greca A. Set up of a dedicated COVID-19 surgical pathway and operating room for surgical emergencies. J Trauma Acute Care Surg. 2020 Oct;89(4):e97-e100. doi: 10.1097/TA.0000000000002852. No abstract available.
- Individual participant dataSharing planned: Yes
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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 Surgery and covid19, run by Associazione Chirurghi Ospedalieri Italiani at 1 site 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 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 1 Apr 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 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?
surgery volume during covid19 lockdown (time frame: 8months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04824664, which also lists 2 linked publications.
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 1 Apr 2021.