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CompletedNCT04824664ALIGHIERIUpdated Apr 1, 2021

The ALIGHIERI Survey: an Italian Overview of Global Impact of tHe COVID-19 pandemIc on General surgERy practIce

An observational study in Surgery and covid19, sponsored by Associazione Chirurghi Ospedalieri Italiani. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by Associazione Chirurghi Ospedalieri Italiani · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
400
Sex
All
01

Study 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. 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. .

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Conditions studied

  • Surgery and covid19

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03

In context

COVID-19

7,776 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 400 is above the median of 260 across 3,188 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Associazione Chirurghi Ospedalieri Italiani is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

all Italian general surgeon

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • alla surgeon in activity

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Interventions

  • Othersurvey

    survey among surgeon

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What researchers measure

Primary outcomes

  1. surgery volume during covid19 lockdown

    number of surgical procedure performed all over italy during covid19 first lockdown

    Time frame: 8months

Secondary outcomes

  1. surgery volume after the first covid19 lockdown

    number of surgical procedure performed all over italy during re start period

    Time frame: 3 months

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Study locations

1 site
  • ACOI
    Rome, Lazio 00136, Italy
08

References and documents

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 32583216 ↗
  • Fransvea 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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2020 to primary completion in Jul 2020, 6 months.

Of 1,625 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 6 months is below that.

Counting every sponsor, half of 1,750 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2021
First posted
Apr 1, 2021
StartActual
Jan 1, 2020
Primary completionActual
Jul 30, 2020
CompletionActual
Dec 30, 2020
Last update
Apr 1, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04824664
Lead sponsor
Associazione Chirurghi Ospedalieri Italiani
Responsible party
Pietro Fransvea (MD, Associazione Chirurghi Ospedalieri Italiani) — Principal investigator
First posted
Apr 1, 2021
Start date
Jan 1, 2020
Primary completion
Jul 30, 2020
Completion
Dec 30, 2020
Last update
Apr 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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