NCT05323851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
581

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

March 30, 2022

Last Update Submit

November 17, 2022

Conditions

Keywords

COVID-19SurveyEnhanced Recovery After Surgery (ERAS) protocolperioperative management

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Other Outcomes (1)

  • Expectation of the Italian surgical daily practice after coronavirus pandemic (COVID-19)

    12 months after the release of COVID-surg-SPIGC questionnaire.

Study Arms (1)

Surgeon

Any Resident, Fellow, PhD candidate, consultant or attending surgeon in any surgical specialty in Italy

Behavioral: COVID-surg-SPIGC questionnaire

Interventions

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.

Surgeon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • undergraduate students
  • Non-Surgical consultant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Azienza ospedaliera S. Camillo Forlanini

Roma, Rome, 00152, Italy

Location

Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

Location

Università degli Studi di Roma Tor Vergata

Roma, 00133, Italy

Location

Related Publications (5)

  • 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.

    PMID: 32557207BACKGROUND
  • 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.

    PMID: 32871849BACKGROUND
  • 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.

    PMID: 32503826BACKGROUND
  • 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.

    PMID: 34157090BACKGROUND
  • 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.

    PMID: 33393172BACKGROUND

MeSH Terms

Conditions

COVID-19Health Behavior

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Roberta Angelico

    University of Rome Tor Vergata

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FEBS, Senior Lecturer, Department of Surgical Science, Tor Vergata University.

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 12, 2022

Study Start

March 16, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations