Surgery During Covid-19: The Role of Asymptomatic Patient... | NCT04344197

Studies
Surgery During Covid-19: The Role of Asymptomatic Patients, a Survey

NCT04344197

Sponsor

University of Rome Tor Vergata

Status

Completed

Last Update Posted

Dec 29, 2020Actual

Enrollment

1,200Actual

Phase

Not provided

Conditions

Surgery
COVID
Asymptomatic Patient
Covid-19
Preventive Measures

Interventions

global survey

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2020Actual

Primary Completion Date

Apr 8, 2020Actual

Completion Date

Apr 15, 2020Actual

First Submitted Date

Apr 9, 2020

First Submission Date that Met QC Criteria

Apr 9, 2020

First Posted Date

Apr 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2020

Last Update Posted Date

Dec 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giuseppe Sigismondo Sica, Associate Professor, Head of Department, University of Rome Tor VergataPrincipal Investigator

Lead Sponsor

University of Rome Tor VergataOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

a brief questionnaire to get a clearer picture of the situation regarding surgical patients with special emphasis on asymptomatic Covid-19 patients.

Detailed Description

With new evidence on the role of asymptomatic patients in spreading the disease during the Covid-19 pandemic, symptom driven guidelines for testing, hospital allocation and personal protective equipment (PPE) use do not seem appropriate to limit in-hospital transmission. At time when lockdowns are in place in most countries, hospitals can become the new source of infection.

Guidelines are very variable depending on local policies and availability of medical supplies, resulting in most hospitals taking different preventive measures.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Name	Type	Description	Arm Group Labels	Other Names
global survey	Other	surgery questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overview of surgical management on preventive measures of hospital infection spread during covid 19		2/04/2020 to 15/04/2020

Secondary Outcomes

Measure	Description	Time Frame
testing policies and preventive measures for Covid-19, and their association with asymptomatic cases.		02/04/2020 to 15/04/2020

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

general surgeon

Exclusion Criteria:

other speciality

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

surgeon

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tor Vergata Hospital		Rome		00133	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33110590	Derived	Bellato V, Konishi T, Pellino G, An Y, Piciocchi A, Sensi B, Siragusa L, Khanna K, Pirozzi BM, Franceschilli M, Campanelli M, Efetov S, Sica GS; S-COVID Collaborative Group. Screening policies, preventive measures and in-hospital infection of COVID-19 in global surgical practices. J Glob Health. 2020 Dec;10(2):020507. doi: 10.7189/jogh.10.020507.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections