<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04407117</url>
  </required_header>
  <id_info>
    <org_study_id>APPCOVID-19</org_study_id>
    <nct_id>NCT04407117</nct_id>
  </id_info>
  <brief_title>Appendicitis During the National Lockdown During the COVID-19 Pandemic</brief_title>
  <official_title>Change in the Incidence of Appendicitis in a Controlled Environment During the National Lockdown Throughout the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claus Anders Bertelsen, PhD, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nordsjaellands Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to examine whether a nationwide lock-down with an entire population subjugated&#xD;
      to social distancing reduces the incidence of appendicitis. If a reduction is detected it&#xD;
      supports the hypothesis that infectious disease may play a role in the etiology of&#xD;
      appendicitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2017</start_date>
  <completion_date type="Actual">April 19, 2020</completion_date>
  <primary_completion_date type="Actual">April 19, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Appendectomy</measure>
    <time_frame>5 weeks</time_frame>
    <description>Appendectomy or other surgery for appendicitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative length of stay</measure>
    <time_frame>30 days</time_frame>
    <description>Postoperative length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Overall mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of complicated appendicitis</measure>
    <time_frame>5 weeks</time_frame>
    <description>Perforated appendicitis or periappendicular abscess</description>
  </secondary_outcome>
  <enrollment type="Actual">6000000</enrollment>
  <condition>Appendicitis</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lock-down and social distancing</intervention_name>
    <description>Lock-down and social distancing during COVID-19 pandemic</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All persons registered in the Danish National Patient Register, i.e. all persons resident&#xD;
        in Denmark&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Registered in the Danish National Patient Register during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claus A Bertelsen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Nordsjaellands Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nordsjaellands Hospital</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>2239906</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: Lancet. 2017 Oct 14;390(10104):1736.</citation>
    <PMID>26460662</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20937462</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17973298</PMID>
  </reference>
  <reference>
    <citation>Carr NJ. The pathology of acute appendicitis. Ann Diagn Pathol. 2000 Feb;4(1):46-58. doi: 10.1016/s1092-9134(00)90011-x.</citation>
    <PMID>10684382</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>31731890</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22795352</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22661078</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24833844</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28599958</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21775347</PMID>
  </reference>
  <reference>
    <citation>Pedersen CB. The Danish Civil Registration System. Scand J Public Health. 2011 Jul;39(7 Suppl):22-5. doi: 10.1177/1403494810387965.</citation>
    <PMID>21775345</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29554842</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nordsjaellands Hospital</investigator_affiliation>
    <investigator_full_name>Claus Anders Bertelsen, PhD, MD</investigator_full_name>
    <investigator_title>Associate professor, consultant surgeon</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Pandemic</keyword>
  <keyword>Incidence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04407117
org study id: APPCOVID-19
nct id: NCT04407117
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Retrospective
measure: Appendectomy
time frame: 5 weeks
description: Appendectomy or other surgery for appendicitis
measure: Postoperative length of stay
time frame: 30 days
description: Postoperative length of stay
measure: Mortality
time frame: 30 days
description: Overall mortality
measure: Incidence of complicated appendicitis
time frame: 5 weeks
description: Perforated appendicitis or periappendicular abscess
intervention type: Behavioral
intervention name: Lock-down and social distancing
description: Lock-down and social distancing during COVID-19 pandemic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Claus A Bertelsen, PhD
role: Study Director
affiliation: Nordsjaellands Hospital
facility: 
country: Denmark
citation: 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.
PMID: 2239906
citation: 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. Erratum In: Lancet. 2017 Oct 14;390(10104):1736.
PMID: 26460662
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.
PMID: 20937462
citation: 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.
PMID: 17973298
citation: Carr NJ. The pathology of acute appendicitis. Ann Diagn Pathol. 2000 Feb;4(1):46-58. doi: 10.1016/s1092-9134(00)90011-x.
PMID: 10684382
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.
PMID: 31731890
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.
PMID: 22795352
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.
PMID: 22661078
citation: 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.
PMID: 24833844
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.
PMID: 28599958
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.
PMID: 21775347
citation: Pedersen CB. The Danish Civil Registration System. Scand J Public Health. 2011 Jul;39(7 Suppl):22-5. doi: 10.1177/1403494810387965.
PMID: 21775345
citation: 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.
PMID: 29554842
responsible party type: Sponsor-Investigator
investigator affiliation: Nordsjaellands Hospital
investigator full name: Claus Anders Bertelsen, PhD, MD
investigator title: Associate professor, consultant surgeon
mesh term: COVID-19
mesh term: Appendicitis
sharing ipd: No