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OpenTrials
Completed

NCT Number: NCT05323851

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienza ospedaliera S. Camillo Forlanini, Roma, Rome, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-surg-SPIGC questionnaire

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Collaborators

  • SPIGC

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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