How Future Surgery Will Benefit From Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Related Measures Perspective From Italian Young Surgeon Society (SPIGC)

November 17, 2022 updated by: Roberta Angelico, University of Rome Tor Vergata

The coronavirus 2019 pandemic (COVID-19) strongly affected clinical care worldwide. Due to a shortage of hospitals and beds in intensive care units (ICU), in Italy during outbreaks, surgical resources were temporarily and partially shifted to COVID-19 patients. In addition, the risk of cross-infection could have determined a shit in surgical perioperative care.

To counterbalance these limitations, many centers routinely changed their clinical practice, which could be maintained by surgeons across Italy. The aim of the present study is to evaluate how the COVID-19 pandemic determined a change in daily clinical practice among all specialties.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this investigation, organized by the Italian Young Surgeon Society (S.P.I.G.C.), is to establish the impact of the coronavirus 2019 pandemic (COVID-19) on clinical care in Italy.

There will be collected from any Italian surgeon (resident, Fellow, Doctor of Philosophy (Ph.D.) candidate, attending surgeon, professor) impressions by completing a survey on this topic.

The analysis is divided into three study periods. For each question, participants must answer for each period. Time frames were divided according to three distinct phases of the pandemic: pre-COVID-19 period, COVID-19 pandemic period, COVID-19 Endemic period.

The pre-COVID-19 period was defined between eighth March 2019 and seventh March 2020, whereas the COVID-19 pandemic period was identified between the declaration of Italian lockdown measures (eighth March 2020) until the release of this questionnaire (sixteenth March 2022) with the periodic pandemic outbreaks. Finally, COVID-19 endemic period was described as a future phase where lockdown measures and social distancing will be removed.

Study Type

Observational

Enrollment (Actual)

581

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico
      • Roma, Italy, 00133
        • Universita Degli Studi di Roma Tor Vergata
    • Rome
      • Roma, Rome, Italy, 00152
        • Azienza ospedaliera S. Camillo Forlanini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any attending surgeon, resident, PhD candidate, or fellow in any surgical specialty in Italy

Description

Inclusion Criteria:

  • Resident, Fellow, PhD candidate, consultant or attending surgeon in Italy in the following surgical specialties: cardiothoracic surgery, colon and rectal surgery, general surgery, gynecology and obstetrics, gynecologic oncology, neurological surgery, ophthalmic surgery, oral and maxillofacial surgery, orthopedic surgery, otorhinolaryngology, pediatric surgery, plastic and maxillofacial surgery, urology, and vascular surgery

Exclusion Criteria:

  • undergraduate students
  • Non-Surgical consultant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgeon
Any Resident, Fellow, PhD candidate, consultant or attending surgeon in any surgical specialty in Italy
Behavioral: COVID-surg-SPIGC questionnaire
The questionnaire aimed to evaluate how the COVID-19 pandemic determined a shift in daily practice through a multidimensional assessment of surgical clinical care in three different time frames.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The measure of the Italian surgical daily practice before coronavirus pandemic (COVID-19)
Time Frame: 12 months before the beginning of COVID-19 emergency in Italy (between eighth March 2019 and seventh March 2020)

Analysis of this outcome will be held through COVID-surg-SPIGC questionnaire. Variables will be collected as absolute numbers (e.g., number of procedures in a month) or percentages (e.g., percentage of elective surgery compared to total procedures).

A sub-analysis will be held regarding the different surgical subspecialties, Italian medical centers, and academic grades.
12 months before the beginning of COVID-19 emergency in Italy (between eighth March 2019 and seventh March 2020)
The measure of the Italian surgical daily practice during coronavirus pandemic (COVID-19)
Time Frame: COVID-19 pandemic (between eighth March 2020 and sixteenth March 2022)

Analysis of this outcome will be held through COVID-surg-SPIGC questionnaire. Variables will be collected as absolute numbers (e.g., number of procedures in a month) or percentages (e.g., percentage of elective surgery compared to total procedures).

A sub-analysis will be held regarding the different surgical subspecialties, Italian medical centers, and academic grades.
COVID-19 pandemic (between eighth March 2020 and sixteenth March 2022)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expectation of the Italian surgical daily practice after coronavirus pandemic (COVID-19)
Time Frame: 12 months after the release of COVID-surg-SPIGC questionnaire.

Analysis of this outcome will be held through COVID-surg-SPIGC questionnaire. Variables will be collected as absolute numbers (e.g., number of procedures in a month) or percentages (e.g., percentage of elective surgery compared to total procedures).

A sub-analysis will be held regarding the different surgical subspecialties, Italian medical centers, and academic grades.
12 months after the release of COVID-surg-SPIGC questionnaire.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Collaborators

SPIGC

Investigators

  • Principal Investigator: Roberta Angelico, Universita Degli Studi di Roma Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2022

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 9, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-Italiansurg-SPIGC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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