NCT04407117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

3.1 years

First QC Date

May 27, 2020

Last Update Submit

June 17, 2020

Conditions

Keywords

COVID-19PandemicIncidence

Outcome Measures

Primary Outcomes (1)

  • Appendectomy

    Appendectomy or other surgery for appendicitis

    5 weeks

Secondary Outcomes (3)

  • Postoperative length of stay

    30 days

  • Mortality

    30 days

  • Incidence of complicated appendicitis

    5 weeks

Interventions

Lock-down and social distancing during COVID-19 pandemic

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjaellands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (14)

  • 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: 2239906BACKGROUND
  • 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.

    PMID: 26460662BACKGROUND
  • 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: 20937462BACKGROUND
  • 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: 17973298BACKGROUND
  • 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: 10684382BACKGROUND
  • 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: 31731890BACKGROUND
  • 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: 22795352BACKGROUND
  • 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: 22661078BACKGROUND
  • 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: 24833844BACKGROUND
  • 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: 28599958BACKGROUND
  • 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: 21775347BACKGROUND
  • Pedersen CB. The Danish Civil Registration System. Scand J Public Health. 2011 Jul;39(7 Suppl):22-5. doi: 10.1177/1403494810387965.

    PMID: 21775345BACKGROUND
  • 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: 29554842BACKGROUND
  • 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.

MeSH Terms

Conditions

AppendicitisCOVID-19

Interventions

Physical Distancing

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Communicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Claus A Bertelsen, PhD

    Nordsjaellands Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor, consultant surgeon

Study Record Dates

First Submitted

May 27, 2020

First Posted

May 29, 2020

Study Start

March 23, 2017

Primary Completion

April 19, 2020

Study Completion

April 19, 2020

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations