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

Sponsor
University of Rome Tor Vergata (Other)
Overall Status
Recruiting
CT.gov ID
NCT05323851
Collaborator
SPIGC (Other)
1,000
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2
333.3
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: COVID-surg-SPIGC questionnaire

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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
How Future Surgery Will Benefit From Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Related Measures Perspective From Italian Young Surgeon Society (SPIGC)
Actual Study Start Date :
Mar 16, 2022
Anticipated Primary Completion Date :
May 15, 2022
Anticipated Study Completion Date :
May 15, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The measure of the Italian surgical daily practice before coronavirus pandemic (COVID-19) [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) [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 Outcome Measures

  1. Expectation of the Italian surgical daily practice after coronavirus pandemic (COVID-19) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienza ospedaliera S. Camillo Forlanini Roma Rome Italy 00152
2 Policlinico Universitario Campus Bio-Medico Roma Italy 00128
3 Università degli Studi di Roma Tor Vergata Roma Italy 00133

Sponsors and Collaborators

  • University of Rome Tor Vergata
  • SPIGC

Investigators

  • Principal Investigator: Roberta Angelico, Università degli Studi di Roma Tor Vergata

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Roberta Angelico, MD, PhD, FEBS, Senior Lecturer, Department of Surgical Science, Tor Vergata University., University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT05323851
Other Study ID Numbers:
  • COVID-Italiansurg-SPIGC
First Posted:
Apr 12, 2022
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Roberta Angelico, MD, PhD, FEBS, Senior Lecturer, Department of Surgical Science, Tor Vergata University., University of Rome Tor Vergata
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022