Appendicitis Clinical Trial
Official title:
Change in the Incidence of Appendicitis in a Controlled Environment During the National Lockdown Throughout the COVID-19 Pandemic
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 |
Verified date | June 2020 |
Source | Nordsjaellands Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Nordsjaellands Hospital | Hillerød |
Lead Sponsor | Collaborator |
---|---|
Claus Anders Bertelsen, PhD, MD |
Denmark,
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 all — Click here to view all references
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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