AzTrials
AzTrials

AppendicitisNCT04407117

Appendicitis During the National Lockdown During the COVID-19 Pandemic

An observational study of Appendicitis, run by Claus Anders Bertelsen, PhD, MD at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Appendicitis
What is being tested?
Lock-down and social distancing
How many people
6,000,000 participants
Where
1 siteDenmark
Study dates
23 Mar 2017to 19 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Registered in the Danish National Patient Register during the study period

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Nordsjaellands Hospital

    Hillerød, 3400

Other trials in Denmark

About this study

Official title: Change in the Incidence of Appendicitis in a Controlled Environment During the National Lockdown Throughout the COVID-19 Pandemic

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.

Conditions
Appendicitis
Being tested
Lock-down and social distancing
Keywords
COVID-19, Pandemic, Incidence
Medical subject headings
Appendicitis, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lock-down and social distancingBehavioural

    Lock-down and social distancing during COVID-19 pandemic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Appendectomy

    Appendectomy or other surgery for appendicitis

    Measured: 5 weeks

Secondary outcomes (3)

  1. Postoperative length of stay

    Postoperative length of stay

    Measured: 30 days

  2. Mortality

    Overall mortality

    Measured: 30 days

  3. Incidence of complicated appendicitis

    Perforated appendicitis or periappendicular abscess

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start23 Mar 2017
  3. Primary completion19 Apr 2020
  4. Study completion19 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
6,000,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04407117
Sponsor's protocol ID
APPCOVID-19
Status last verified
Jun 2020
First submitted
27 May 2020
Last updated
19 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 2239906

  • 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.

    PubMed 26460662

  • Lamps LW. Infectious causes of appendicitis. Infect Dis Clin North Am. 2010 Dec;24(4):995-1018, ix-x. doi: 10.1016/j.idc.2010.07.012.

    PubMed 20937462

  • Dzabic M, Bostrom L, Rahbar A. High prevalence of an active cytomegalovirus infection in the appendix of immunocompetent patients with acute appendicitis. Inflamm Bowel Dis. 2008 Feb;14(2):236-41. doi: 10.1002/ibd.20299.

    PubMed 17973298

  • Carr NJ. The pathology of acute appendicitis. Ann Diagn Pathol. 2000 Feb;4(1):46-58. doi: 10.1016/s1092-9134(00)90011-x.

    PubMed 10684382

  • Hsu YJ, Fu YW, Chin T. Seasonal variations in the occurrence of acute appendicitis and their relationship with the presence of fecaliths in children. BMC Pediatr. 2019 Nov 16;19(1):443. doi: 10.1186/s12887-019-1824-9.

    PubMed 31731890

  • Wei PL, Chen CS, Keller JJ, Lin HC. Monthly variation in acute appendicitis incidence: a 10-year nationwide population-based study. J Surg Res. 2012 Dec;178(2):670-6. doi: 10.1016/j.jss.2012.06.034. Epub 2012 Jul 6.

    PubMed 22795352

  • Stein GY, Rath-Wolfson L, Zeidman A, Atar E, Marcus O, Joubran S, Ram E. Sex differences in the epidemiology, seasonal variation, and trends in the management of patients with acute appendicitis. Langenbecks Arch Surg. 2012 Oct;397(7):1087-92. doi: 10.1007/s00423-012-0958-0. Epub 2012 Jun 2.

    PubMed 22661078

  • Ilves I, Fagerstrom A, Herzig KH, Juvonen P, Miettinen P, Paajanen H. Seasonal variations of acute appendicitis and nonspecific abdominal pain in Finland. World J Gastroenterol. 2014 Apr 14;20(14):4037-42. doi: 10.3748/wjg.v20.i14.4037.

    PubMed 24833844

  • Reinisch A, Heil J, Woeste G, Bechstein W, Liese J. The meteorological influence on seasonal alterations in the course of acute appendicitis. J Surg Res. 2017 Sep;217:137-143. doi: 10.1016/j.jss.2017.05.015. Epub 2017 May 10.

    PubMed 28599958

  • Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health. 2011 Jul;39(7 Suppl):30-3. doi: 10.1177/1403494811401482.

    PubMed 21775347

  • Pedersen CB. The Danish Civil Registration System. Scand J Public Health. 2011 Jul;39(7 Suppl):22-5. doi: 10.1177/1403494810387965.

    PubMed 21775345

  • Kleif J, Thygesen LC, Gogenur I. Validity of the diagnosis of appendicitis in the Danish National Patient Register. Scand J Public Health. 2020 Feb;48(1):38-42. doi: 10.1177/1403494818761765. Epub 2018 Mar 19.

    PubMed 29554842

  • Jantzen AT, Bang-Nielsen A, Bertelsen CA, Torp-Pedersen C, Kleif J. Incidence of appendicitis during COVID-19 lockdown: A nationwide population-based study. Scand J Surg. 2022 Apr-Jun;111(2):14574969221089387. doi: 10.1177/14574969221089387.

    PubMed 35488422

Questions about this trial

What is this clinical trial studying?

An observational study of Appendicitis, run by Claus Anders Bertelsen, PhD, MD at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Appendectomy (time frame: 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04407117, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in