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

COVID-19 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05323851
• Other study ID #: COVID-Italiansurg-SPIGC
• Status: Completed
• Start date: March 16, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: November 2022
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 581
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Health Behavior
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienza ospedaliera S. Camillo Forlanini	Roma	Rome
Italy	Policlinico Universitario Campus Bio-Medico	Roma
Italy	Università degli Studi di Roma Tor Vergata	Roma

Sponsors (2)

Lead Sponsor	Collaborator
University of Rome Tor Vergata	SPIGC

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Buonomo OC, Materazzo M, Pellicciaro M, Caspi J, Piccione E, Vanni G. Tor Vergata University-Hospital in the Beginning of COVID-19-Era: Experience and Recommendation for Breast Cancer Patients. In Vivo. 2020 Jun;34(3 Suppl):1661-1665. doi: 10.21873/invivo.11958. — View Citation

Ielpo B, Podda M, Pellino G, Pata F, Caruso R, Gravante G, Di Saverio S; ACIE Appy Study Collaborative. Global attitudes in the management of acute appendicitis during COVID-19 pandemic: ACIE Appy Study. Br J Surg. 2021 Jun 22;108(6):717-726. doi: 10.1002/bjs.11999. Epub 2020 Oct 8. — View Citation

Manzia TM, Angelico R, Toti L, Pisani G, Vita G, Romano F, Pirozzi BM, Vinci D, Cacciola R, Iaria G, Tisone G. The hamletic dilemma of patients waiting for kidney transplantation during the COVID-19 pandemic: To accept or not to accept (an organ offer)? Transpl Infect Dis. 2021 Apr;23(2):e13560. doi: 10.1111/tid.13560. Epub 2021 Jan 16. — View Citation

Pertile D, Gallo G, Barra F, Pasculli A, Batistotti P, Sparavigna M, Vizzielli G, Soriero D, Graziano G, Di Saverio S, Meniconi RL, Guaitoli E, Mazzarri A; SPIGC Working Group. The impact of COVID-19 pandemic on surgical residency programmes in Italy: a nationwide analysis on behalf of the Italian Polyspecialistic Young Surgeons Society (SPIGC). Updates Surg. 2020 Jun;72(2):269-280. doi: 10.1007/s13304-020-00811-9. Epub 2020 Jun 16. — View Citation

Vanni G, Legramante JM, Pellicciaro M, DE Carolis G, Cotesta M, Materazzo M, Buonomo C, Farinaccio A, Santori F, Saraceno F, Ielpo B, Aiello F, Paganelli C, Grande M, DE Andreis G, Chiocchi M, Palombi L, Buonomo OC. Effect of Lockdown in Surgical Emergency Accesses: Experience of a COVID-19 Hospital. In Vivo. 2020 Sep-Oct;34(5):3033-3038. doi: 10.21873/invivo.12137. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expectation of the Italian surgical daily practice after coronavirus pandemic (COVID-19)	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.
Primary	The measure of the Italian surgical daily practice before coronavirus pandemic (COVID-19)	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)
Primary	The measure of the Italian surgical daily practice during coronavirus pandemic (COVID-19)	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)