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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04407117
Other study ID # APPCOVID-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 23, 2017
Est. completion date April 19, 2020

Study information

Verified date June 2020
Source Nordsjaellands Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 6000000
Est. completion date April 19, 2020
Est. primary completion date April 19, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Registered in the Danish National Patient Register during the study period

Exclusion Criteria:

None

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Nordsjaellands Hospital Hillerød

Sponsors (1)

Lead Sponsor Collaborator
Claus Anders Bertelsen, PhD, MD

Country where clinical trial is conducted

Denmark, 

References & Publications (13)

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. — View Citation

Bhangu A, Søreide 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. Review. Erratum in: Lancet. 2017 Oct 14;390(10104):1736. — View Citation

Carr NJ. The pathology of acute appendicitis. Ann Diagn Pathol. 2000 Feb;4(1):46-58. Review. — View Citation

Dzabic M, Boström 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. — View Citation

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. — View Citation

Ilves I, Fagerström 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. — View Citation

Kleif J, Thygesen LC, Gögenur 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. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Appendectomy Appendectomy or other surgery for appendicitis 5 weeks
Secondary Postoperative length of stay Postoperative length of stay 30 days
Secondary Mortality Overall mortality 30 days
Secondary Incidence of complicated appendicitis Perforated appendicitis or periappendicular abscess 5 weeks
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