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Appendicitis During the National Lockdown During the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407117
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Claus Anders Bertelsen, PhD, MD, Nordsjaellands Hospital

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.

Condition or disease Intervention/treatment
Appendicitis Behavioral: Lock-down and social distancing

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Study Type : Observational
Actual Enrollment : 6000000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Change in the Incidence of Appendicitis in a Controlled Environment During the National Lockdown Throughout the COVID-19 Pandemic
Actual Study Start Date : March 23, 2017
Actual Primary Completion Date : April 19, 2020
Actual Study Completion Date : April 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis


Intervention Details:
  • Behavioral: Lock-down and social distancing
    Lock-down and social distancing during COVID-19 pandemic


Primary Outcome Measures :
  1. Appendectomy [ Time Frame: 5 weeks ]
    Appendectomy or other surgery for appendicitis


Secondary Outcome Measures :
  1. Postoperative length of stay [ Time Frame: 30 days ]
    Postoperative length of stay

  2. Mortality [ Time Frame: 30 days ]
    Overall mortality

  3. Incidence of complicated appendicitis [ Time Frame: 5 weeks ]
    Perforated appendicitis or periappendicular abscess



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All persons registered in the Danish National Patient Register, i.e. all persons resident in Denmark
Criteria

Inclusion Criteria:

Registered in the Danish National Patient Register during the study period

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407117


Locations
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Denmark
Nordsjaellands Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Claus Anders Bertelsen, PhD, MD
Investigators
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Study Director: Claus A Bertelsen, PhD Nordsjaellands Hospital
Publications:

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Responsible Party: Claus Anders Bertelsen, PhD, MD, Associate professor, consultant surgeon, Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT04407117    
Other Study ID Numbers: APPCOVID-19
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claus Anders Bertelsen, PhD, MD, Nordsjaellands Hospital:
COVID-19
Pandemic
Incidence
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases