The ALIGHIERI Survey: an Italian Overview of Global Impac... | NCT04824664

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

NCT04824664

Sponsor

Associazione Chirurghi Ospedalieri Italiani

Status

Completed

Last Update Posted

Apr 1, 2021Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Surgery and covid19

Interventions

survey

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jul 30, 2020Actual

Completion Date

Dec 30, 2020Actual

First Submitted Date

Mar 29, 2021

First Submission Date that Met QC Criteria

Mar 30, 2021

First Posted Date

Apr 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2021

Last Update Posted Date

Apr 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pietro Fransvea, MD, Associazione Chirurghi Ospedalieri ItalianiPrincipal Investigator

Lead Sponsor

Associazione Chirurghi Ospedalieri ItalianiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Name	Type	Description	Arm Group Labels	Other Names
survey	Other	survey among surgeon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surgery volume during covid19 lockdown	number of surgical procedure performed all over italy during covid19 first lockdown	8months

Secondary Outcomes

Measure	Description	Time Frame
surgery volume after the first covid19 lockdown	number of surgical procedure performed all over italy during re start period	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

alla surgeon in activity

Exclusion Criteria:

none

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all Italian general surgeon

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ACOI		Rome	Lazio	00136	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32583216	Background	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.
33017138	Result

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms