Emergency Surgery During Covid Compared to Emergency Surg... | NCT05476315

Studies
Emergency Surgery During Covid Compared to Emergency Surgery During Pre-covid Period

NCT05476315

Sponsor

University of Foggia

Status

Completed

Last Update Posted

Jul 27, 2022Actual

Enrollment

356Actual

Phase

Not provided

Conditions

Emergencies
Surgery
COVID-19

Interventions

Emergency surgery during covid-19 pandemic

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

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

Mar 9, 2019Actual

Primary Completion Date

May 9, 2021Actual

Completion Date

May 9, 2022Actual

First Submitted Date

Jul 25, 2022

First Submission Date that Met QC Criteria

Jul 25, 2022

First Posted Date

Jul 27, 2022Actual

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

Jul 25, 2022

Last Update Posted Date

Jul 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of this study is to analyze the trend of hospitalizations and how emergency operations have qualitatively and quantitatively changed in our Department of Medical and Surgical Sciences of the Foggia Hospital from 2019 (pre-covid era) to date.

Detailed Description

Not provided

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

356Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emergency surgery during covid-19 pandemic	Other	Patients undergoing emergency surgery during the covid period and compared with emergency interventions before the pandemic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Is emergency surgery back to pre-covid-19 era?	How emergency surgery has changed during covid pandemic	From March 2019 to May 2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients underwent emergency surgery from March 2019 to May 2022

Exclusion Criteria:

Patients underwent elective surgery

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

Our cohort-study was conducted by analyzing four groups of patients admitted to the Department of Medical and Surgical Sciences of the Hospital of Foggia, Apulia southern part of Italy :

group 1: people admitted during the no-covid period from March 09th, 2019 to May 09th, 2019;
group 2: people admitted from March 09th, 2020 to May 09th, 2020;
group 3: people admitted from March 09th, 2021 to May 09th, 2021
group 4: people admitted from March 09th, 2022 to May 09th, 2022

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giovanna Pavone	University of Foggia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Foggia		Foggia		71122	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 23, 2022	Jul 25, 2022	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies
D000086382	COVID-19

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D011024	Pneumonia, Viral

Browse Leaves

Not provided

Browse Branches

Not provided