Appendicitis During the National Lockdown During the COVI... | NCT04407117

Studies
Appendicitis During the National Lockdown During the COVID-19 Pandemic

NCT04407117

Sponsor

Claus Anders Bertelsen, PhD, MD

Status

Completed

Last Update Posted

Jun 19, 2020Actual

Enrollment

6,000,000Actual

Phase

Not provided

Conditions

Appendicitis

Interventions

Lock-down and social distancing

Countries

Denmark

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

Jun 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

Mar 23, 2017Actual

Primary Completion Date

Apr 19, 2020Actual

Completion Date

Apr 19, 2020Actual

First Submitted Date

May 27, 2020

First Submission Date that Met QC Criteria

May 27, 2020

First Posted Date

May 29, 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

Jun 17, 2020

Last Update Posted Date

Jun 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claus Anders Bertelsen, PhD, MD, Associate professor, consultant surgeon, Nordsjaellands HospitalSponsor-Investigator

Lead Sponsor

Claus Anders Bertelsen, PhD, MDOTHER

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 study aims to examine whether a nationwide lock-down with an entire population subjugated to social distancing reduces the incidence of appendicitis. If a reduction is detected it supports the hypothesis that infectious disease may play a role in the etiology of appendicitis.

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

6,000,000Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lock-down and social distancing	Behavioral	Lock-down and social distancing during COVID-19 pandemic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Appendectomy	Appendectomy or other surgery for appendicitis	5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Postoperative length of stay	Postoperative length of stay	30 days
Mortality	Overall mortality	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Registered in the Danish National Patient Register during the study period

Exclusion Criteria:

None

Accepts Healthy Volunteers

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

All persons registered in the Danish National Patient Register, i.e. all persons resident in Denmark

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claus A Bertelsen, PhD	Nordsjaellands Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nordsjaellands Hospital		Hillerød		3400	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2239906	Background	Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol. 1990 Nov;132(5):910-25. doi: 10.1093/oxfordjournals.aje.a115734.
26460662	Background	Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

ID	Term
D003140	Communicable Disease Control
D015980	Public Health Practice
D011634	Public Health
D004778	Environment and Public Health