ClinicalTrials.gg
CompletedNCT04338945Updated Mar 17, 2022

Impact of Pandemic COVID-19 on Surgical Specialities Residents in Italy

An observational study in COVID, sponsored by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia. Completed at 7 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study summary

The Coronavirus Emergency has severely affected Italian Healthcare National System. This event made it necessary to adopt extraordinary containment measures and to allocate extraordinary resources in Italian hospitals. In many centers routinely elective surgical activity has been decreased or even completely abolished. We believe that this exceptional condition is being consequently having a significant impact on surgical training programs.

Read the detailed description

Purpose of this investigation, organized by the Italian Polispecialistic Society of Young Surgeons (S.P.I.G.C.), is to establish the impact of COVID-19 emergency in the work and training activities of Italian surgical residents.

There will be collected the residents' impressions by completing a survey on this topic. A sub-analysis for each pandemic wave (first, second, third) will be done.

02

Conditions studied

  • COVID

Keywords

  • resident wellness
  • surgical residency
03

In context

Lead sponsor

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Italian medical residents in surgical areas

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Residents in the following surgical specialities: cardiothoracic surgery, colon and rectal surgery, general surgery, gynecology and obstetrics, gynecologic oncology, neurological surgery, ophthalmic surgery, oral and maxillofacial surgery, orthopaedic surgery, otorhinolaryngology, pediatric surgery, plastic and maxillofacial surgery, urology, and vascular surgery

Exclusion criteria

Exclusion Criteria:

  • Undergratuated and postgraduated students
  • Consultants in surgical areas
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (actual)
Patient registry
No

Groups and cohorts

  • Residents in surgical areas

    Behavioral: COVID-surgRES questionaire

Interventions

  • BehavioralCOVID-surgRES questionaire

    The questionaire gives a multidimensional assessment of residents' impression with regard to impact of COVID emergency on Italian specialist training programs

06

What researchers measure

Primary outcomes

  1. Measure of the impact of first wave of COVID Pandemic on surgical specialist training programs

    Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers

    Time frame: 1-3 months after the beginning of COVID emergency in Italy

  2. Measure of the impact of second wave of COVID Pandemic on surgical specialist training programs

    Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers

    Time frame: 1 year after the beginning of COVID emergency in Italy

  3. Measure of the impact of third wave of COVID Pandemic on surgical specialist training programs

    Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers

    Time frame: 2 years after the beginning of COVID emergency in Italy

Secondary outcomes

  1. Measure of impact of first wave of COVID Pandemic on wellness of residents

    Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers

    Time frame: 1-3 months after the beginning of COVID emergency in Italy

  2. Measure of impact of second wave of COVID Pandemic on wellness of residents

    Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers

    Time frame: 1 year after the beginning of COVID emergency in Italy

  3. Measure of impact of third wave of COVID Pandemic on wellness of residents

    Analysis of this outcome with regard to the different surgical subspecialities and different Italian medical centers

    Time frame: 2 years after the beginning of COVID emergency in Italy

07

Study locations

7 sites
  • U.O.C. Chirurgia Generale Universitaria "V. Bonomo"
    Bari, Italy
  • Ospedale Perrino Asl Brindisi
    Brindisi, Italy
  • Dipartimento di scienze mediche e chirurgiche, Università di Catanzaro
    Catanzaro, Italy
  • Ospedale Policlinico San Martino
    Genova, Italy
  • Azienda Ospedaliera San Camillo-Forlanini
    Roma, Italy
  • IRCCS Fondazione Policlinico Universitario Agostino Gemelli
    Roma, Italy
  • Ospedale Cristo re
    Roma, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2020 to primary completion in Apr 2020, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2020
First posted
Apr 8, 2020
StartActual
Mar 15, 2020
Primary completionActual
Apr 15, 2020
CompletionActual
May 1, 2020
Last update
Mar 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04338945
Lead sponsor
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Responsible party
Simone Ferrero (MD, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia) — Principal investigator
First posted
Apr 8, 2020
Start date
Mar 15, 2020
Primary completion
Apr 15, 2020
Completion
May 1, 2020
Last update
Mar 17, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion