Incidence and Outcomes of Emergency Department Patients R... | NCT05664360

Studies
Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery

NCT05664360

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Dec 23, 2022Actual

Enrollment

310,914Actual

Phase

Not provided

Conditions

Emergency General Surgery

Interventions

Age (young versus older)

Countries

Not provided

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 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

Jan 1, 2015Actual

Primary Completion Date

Mar 15, 2022Actual

Completion Date

Mar 15, 2022Actual

First Submitted Date

Dec 9, 2022

First Submission Date that Met QC Criteria

Dec 17, 2022

First Posted Date

Dec 23, 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

Dec 17, 2022

Last Update Posted Date

Dec 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christophe Fehlmann, Principal Investigator, University Hospital, GenevaPrincipal Investigator

Lead Sponsor

University Hospital, GenevaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 objectives of this study were (1) to estimate the incidence of emergency general surgery in a Swiss University Hospital, (2) to describe the characteristics and outcomes of patients undergoing such interventions, and (3) to study the impact of age on the outcomes.

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

310,914Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ED patients			Other: Age (young versus older)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Age (young versus older)	Other	Age	ED patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of emergency general surgery	Emergency general surgery following ED visit	Day 3

Secondary Outcomes

Measure	Description	Time Frame
Admission to intensive care unit rate	Admission to intensive care unit	During index hospitalization
ICU length of stay	Number of days spent in the ICU during hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- consecutive patients visiting the emergency department

Exclusion Criteria:

admitted primarily for a psychiatric reason
left without consultation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients visiting the emergency department

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christophe A Fehlmann, MD	Genava University Hospitals	Principal Investigator

Locations

Not provided

ID	Type	URL	Comment
	Individual Participant Data Set	View IPD

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Analytic Code

Time Frame

As soon as published

Access Criteria

Without restriction

URL

https://www.doi.org/10.17605/OSF.IO/TRU4N

Intervention Browse Module

MeSH Terms

ID	Term
D000375	Aging

Ancestor Terms

ID	Term
D048788	Growth and Development
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided