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

An observational study of COVID-19 and Health Behavior, run by University of Rome Tor Vergata at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19, Health Behavior
What is being tested?: COVID-surg-SPIGC questionnaire
Type of treatment: Lifestyle or therapy programme
How many people: 581 participants
Where: 3 sitesItaly
Study dates: 16 Mar 2022to 1 Jul 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Who cannot join

undergraduate students
Non-Surgical consultant

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

Azienza ospedaliera S. Camillo Forlanini
Roma, Rome, 00152
Policlinico Universitario Campus Bio-Medico
Roma, 00128
Università degli Studi di Roma Tor Vergata
Roma, 00133

Other trials in Italy

About this study

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.

Read the 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.

Conditions: COVID-19, Health Behavior
Being tested: COVID-surg-SPIGC questionnaire
Keywords: COVID-19, Survey, Enhanced Recovery After Surgery (ERAS) protocol, perioperative management
Medical subject headings: COVID-19, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COVID-surg-SPIGC questionnaireBehavioural
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.

Study groups in NCT05323851
Study group	Role	What they receive
Surgeon		Any Resident, Fellow, PhD candidate, consultant or attending surgeon in any surgical specialty in Italy Receives: Behavioral: COVID-surg-SPIGC questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: COVID-19 pandemic (between eighth March 2020 and sixteenth March 2022)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 20221 Jul 2022

First posted12 Apr 2022
Study start16 Mar 2022
Primary completion1 Jul 2022
Study completion1 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 581 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05323851
Sponsor's protocol ID: COVID-Italiansurg-SPIGC
Status last verified: Nov 2022
First submitted: 30 Mar 2022
Last updated: 21 Nov 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32557207
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.
PubMed 32871849
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.
PubMed 32503826
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.
PubMed 34157090
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.
PubMed 33393172

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05323851
Acronym / sponsor ID: COVID-Italiansurg-SPIGC
Conditions: COVID-19, Health Behavior
Keywords: COVID-19, Survey, Enhanced Recovery After Surgery (ERAS) protocol, perioperative management
Study type: Observational
Recruitment status: Completed
Enrolment: 581 participants (actual)
Lead sponsor: University of Rome Tor VergataUniversity, hospital or other
Collaborators: SPIGC
Study start: 16 Mar 2022 (actual)
Primary completion: 1 Jul 2022 (actual)
Study completion: 1 Jul 2022 (actual)
First posted: 12 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Surgeon	–	Behavioral: COVID-surg-SPIGC questionnaireAny Resident, Fellow, PhD candidate, consultant or attending surgeon in any surgical specialty in Italy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Any attending surgeon, resident, PhD candidate, or fellow in any surgical specialty in Italy

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

undergraduate students
Non-Surgical consultant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COVID-surg-SPIGC questionnaireThe 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.	Behavioural	Surgeon

Primary outcome

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
Background: PubMed 32557207Pertile 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.
Background: PubMed 32871849Vanni 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.
Background: PubMed 32503826Buonomo 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.
Background: PubMed 34157090Ielpo 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.
Background: PubMed 33393172Manzia 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roberta Angelico principal investigator

University of Rome Tor Vergata

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Health Behavior, run by University of Rome Tor Vergata at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05323851, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.