<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/NCT04477824</url>
  </required_header>
  <id_info>
    <org_study_id>APP-DIM</org_study_id>
    <nct_id>NCT04477824</nct_id>
  </id_info>
  <brief_title>Is Acute Appendicitis Still a Clinical Diagnosis?</brief_title>
  <official_title>Is Acute Appendicitis Still a Clinical Diagnosis? Use of Preoperative Diagnostic Imaging Before Appendectomy in Denmark During 2000-15.</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate the use of preoperative diagnostic imaging before appendectomy&#xD;
      in Denmark and whether it has changed over time during the period from 2000-15. Secondly, the&#xD;
      study aims to investigate regional, age and gender differences in the same setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute appendicitis is the most common cause of abdominal pain (1) and appendectomy is the&#xD;
      most common emergency surgical procedure performed worldwide (2). During the last decades,&#xD;
      there has been a paradigm shift in both diagnosis and treatment of appendicitis - surgical&#xD;
      treatment has changed from open to laparoscopic appendectomy (3). Acute appendicitis has&#xD;
      traditionally been a clinical diagnosis, but the use of preoperative diagnostic imaging has,&#xD;
      in some countries, increased dramatically (4). The use of computed tomography (CT) before&#xD;
      appendectomy is in the United States up to 90%, in England 13% and in Holland almost all&#xD;
      patients undergo ultrasound and/or CT before appendectomy (1).&#xD;
&#xD;
      The use of antibiotics can be successful in the treatment of uncomplicated appendicitis&#xD;
      verified on CT, and the use of CT has significantly lowered the negative appendectomy rate&#xD;
      compared to clinical evaluation only (1). But the use of CT is inevitably inducing radiation&#xD;
      and increasing lifetime risk of cancer - especially in younger patients who most frequently&#xD;
      present with acute appendicitis (1,5). It is estimated that CT of the abdominal region can&#xD;
      avoid 12 negative appendectomies but at the cost of one cancer death due to radiation (5). In&#xD;
      Denmark surgery is still the only treatment for appendicitis, but how is appendicitis&#xD;
      diagnosed? Is acute appendicitis still a clinical diagnosis?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2000</start_date>
  <completion_date type="Actual">January 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Annual percentage use diagnostic imaging before appendectomy</measure>
    <time_frame>24 hours</time_frame>
    <description>Annual percentage use of abdominal ultrasonography, abdominal computerized tomography (with or without contrast) and abdominal MRI 24 hours before appendectomy for appendicitis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in use of ultrasonography.</measure>
    <time_frame>24 hours</time_frame>
    <description>Differences in use of ultrasonography between gender, age groups divided into decades and the five Danish administrative regions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in use of abdominal computerized tomography (with or without contrast)</measure>
    <time_frame>24 hours</time_frame>
    <description>Differences in use of abdominal computerized tomography (with or without contrast) between gender, age groups divided into decades and the five Danish administrative regions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in use of magnetic resonance imaging</measure>
    <time_frame>24 hours</time_frame>
    <description>Differences in use of magnetic resonance imaging between gender, age groups divided into decades and the five Danish administrative regions.</description>
  </secondary_outcome>
  <enrollment type="Actual">82000</enrollment>
  <condition>Appendicitis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Diagnostic imaging</intervention_name>
    <description>Ultrasonography, computerized tomography, magnetic resonance imaging</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients in Denmark with a diagnosis for appendicitis undergoing appendectomy during&#xD;
        the same admission during the period 2000-15&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis for appendicitis undergoing appendectomy during the same&#xD;
             admission during the period 2000-15&#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 Chair</role>
    <affiliation>Nordsjaellands Hospital</affiliation>
  </overall_official>
  <link>
    <url>https://drive.google.com/file/d/1W54pSz_HHao0iGrteYMsJyCADH5aQnYL/view?usp=sharing</url>
    <description>Protocol</description>
  </link>
  <reference>
    <citation>Rud B, Vejborg TS, Rappeport ED, Reitsma JB, Wille-Jorgensen P. Computed tomography for diagnosis of acute appendicitis in adults. Cochrane Database Syst Rev. 2019 Nov 19;2019(11):CD009977. doi: 10.1002/14651858.CD009977.pub2.</citation>
    <PMID>31743429</PMID>
  </reference>
  <reference>
    <citation>GlobalSurg Collaborative. Mortality of emergency abdominal surgery in high-, middle- and low-income countries. Br J Surg. 2016 Jul;103(8):971-988. doi: 10.1002/bjs.10151. Epub 2016 May 4. Erratum In: Br J Surg. 2017 Apr;104(5):632.</citation>
    <PMID>27145169</PMID>
  </reference>
  <reference>
    <citation>Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.</citation>
    <PMID>27437029</PMID>
  </reference>
  <reference>
    <citation>Raja AS, Wright C, Sodickson AD, Zane RD, Schiff GD, Hanson R, Baeyens PF, Khorasani R. Negative appendectomy rate in the era of CT: an 18-year perspective. Radiology. 2010 Aug;256(2):460-5. doi: 10.1148/radiol.10091570. Epub 2010 Jun 7.</citation>
    <PMID>20529988</PMID>
  </reference>
  <reference>
    <citation>Rogers W, Hoffman J, Noori N. Harms of CT scanning prior to surgery for suspected appendicitis. Evid Based Med. 2015 Feb;20(1):3-4. doi: 10.1136/ebmed-2014-110075. Epub 2014 Nov 27.</citation>
    <PMID>25429870</PMID>
  </reference>
  <reference>
    <citation>von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.</citation>
    <PMID>25046131</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>
  <reference>
    <citation>Sallinen V, Akl EA, You JJ, Agarwal A, Shoucair S, Vandvik PO, Agoritsas T, Heels-Ansdell D, Guyatt GH, Tikkinen KA. Meta-analysis of antibiotics versus appendicectomy for non-perforated acute appendicitis. Br J Surg. 2016 May;103(6):656-667. doi: 10.1002/bjs.10147. Epub 2016 Mar 17.</citation>
    <PMID>26990957</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 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>Appendicitis</keyword>
  <keyword>Appendectomy</keyword>
  <keyword>Preoperative diagnostic imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04477824
org study id: APP-DIM
nct id: NCT04477824
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the use of preoperative diagnostic imaging before appendectomy
      in Denmark and whether it has changed over time during the period from 2000-15. Secondly, the
      study aims to investigate regional, age and gender differences in the same setting.
Acute appendicitis is the most common cause of abdominal pain (1) and appendectomy is the
      most common emergency surgical procedure performed worldwide (2). During the last decades,
      there has been a paradigm shift in both diagnosis and treatment of appendicitis - surgical
      treatment has changed from open to laparoscopic appendectomy (3). Acute appendicitis has
      traditionally been a clinical diagnosis, but the use of preoperative diagnostic imaging has,
      in some countries, increased dramatically (4). The use of computed tomography (CT) before
      appendectomy is in the United States up to 90%, in England 13% and in Holland almost all
      patients undergo ultrasound and/or CT before appendectomy (1).

      The use of antibiotics can be successful in the treatment of uncomplicated appendicitis
      verified on CT, and the use of CT has significantly lowered the negative appendectomy rate
      compared to clinical evaluation only (1). But the use of CT is inevitably inducing radiation
      and increasing lifetime risk of cancer - especially in younger patients who most frequently
      present with acute appendicitis (1,5). It is estimated that CT of the abdominal region can
      avoid 12 negative appendectomies but at the cost of one cancer death due to radiation (5). In
      Denmark surgery is still the only treatment for appendicitis, but how is appendicitis
      diagnosed? Is acute appendicitis still a clinical diagnosis?
observational model: Cohort
time perspective: Prospective
measure: Annual percentage use diagnostic imaging before appendectomy
time frame: 24 hours
description: Annual percentage use of abdominal ultrasonography, abdominal computerized tomography (with or without contrast) and abdominal MRI 24 hours before appendectomy for appendicitis.
measure: Differences in use of ultrasonography.
time frame: 24 hours
description: Differences in use of ultrasonography between gender, age groups divided into decades and the five Danish administrative regions.
measure: Differences in use of abdominal computerized tomography (with or without contrast)
time frame: 24 hours
description: Differences in use of abdominal computerized tomography (with or without contrast) between gender, age groups divided into decades and the five Danish administrative regions.
measure: Differences in use of magnetic resonance imaging
time frame: 24 hours
description: Differences in use of magnetic resonance imaging between gender, age groups divided into decades and the five Danish administrative regions.
intervention type: Diagnostic Test
intervention name: Diagnostic imaging
description: Ultrasonography, computerized tomography, magnetic resonance imaging
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 Chair
affiliation: Nordsjaellands Hospital
url: https://drive.google.com/file/d/1W54pSz_HHao0iGrteYMsJyCADH5aQnYL/view?usp=sharing
description: Protocol
citation: Rud B, Vejborg TS, Rappeport ED, Reitsma JB, Wille-Jorgensen P. Computed tomography for diagnosis of acute appendicitis in adults. Cochrane Database Syst Rev. 2019 Nov 19;2019(11):CD009977. doi: 10.1002/14651858.CD009977.pub2.
PMID: 31743429
citation: GlobalSurg Collaborative. Mortality of emergency abdominal surgery in high-, middle- and low-income countries. Br J Surg. 2016 Jul;103(8):971-988. doi: 10.1002/bjs.10151. Epub 2016 May 4. Erratum In: Br J Surg. 2017 Apr;104(5):632.
PMID: 27145169
citation: Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.
PMID: 27437029
citation: Raja AS, Wright C, Sodickson AD, Zane RD, Schiff GD, Hanson R, Baeyens PF, Khorasani R. Negative appendectomy rate in the era of CT: an 18-year perspective. Radiology. 2010 Aug;256(2):460-5. doi: 10.1148/radiol.10091570. Epub 2010 Jun 7.
PMID: 20529988
citation: Rogers W, Hoffman J, Noori N. Harms of CT scanning prior to surgery for suspected appendicitis. Evid Based Med. 2015 Feb;20(1):3-4. doi: 10.1136/ebmed-2014-110075. Epub 2014 Nov 27.
PMID: 25429870
citation: von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.
PMID: 25046131
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
citation: Sallinen V, Akl EA, You JJ, Agarwal A, Shoucair S, Vandvik PO, Agoritsas T, Heels-Ansdell D, Guyatt GH, Tikkinen KA. Meta-analysis of antibiotics versus appendicectomy for non-perforated acute appendicitis. Br J Surg. 2016 May;103(6):656-667. doi: 10.1002/bjs.10147. Epub 2016 Mar 17.
PMID: 26990957
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: Appendicitis
sharing ipd: Undecided