xml: <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/NCT06000020</url>
    </required_header>
    <id_info>
      <org_study_id>LapApp</org_study_id>
      <nct_id>NCT06000020</nct_id>
    </id_info>
    <brief_title>Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study</brief_title>
    <official_title>Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nordsjaellands Hospital</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>
        Based on a regional cohort, this study we will try to demonstrate the superiority of routine&#xD;
        laparoscopic appendectomy vs. leaving an intraoperative assessed normal appendix in situ in&#xD;
        cases of normal findings at diagnostic laparoscopy. If routine laparoscopic appendectomy is&#xD;
        not superior, we will recommend leaving the &quot;normal&quot; appendix in situ.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a retrospective cohort study with a superiority design. It will be carried out&#xD;
        at the surgical departments of the four public university hospitals providing emergency&#xD;
        surgical service to the entire population of 1,8 million in the Capital Region of Denmark.&#xD;
  &#xD;
        On March 17, 2017, a new electronic health record (EHR) had been implemented at three of the&#xD;
        hospital, while it was implemented at Copenhagen University Hospital - Bispebjerg on May 20,&#xD;
        2017. These dates mark the start of the inclusion period for each hospital, while the&#xD;
        inclusion period ended April 1, 2021 for all four hospitals.&#xD;
  &#xD;
        The &quot;snap boards&quot; covering the relevant operation rooms at the four hospitals will be&#xD;
        systematically review. For all cases, where diagnostic laparoscopy was performed on suspicion&#xD;
        of acute appendicitis, the EHR will be reviewed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 17, 2017</start_date>
    <completion_date type="Anticipated">April 1, 2026</completion_date>
    <primary_completion_date type="Actual">April 1, 2021</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>Risk of surgery on suspicion of acute appendicitis</measure>
      <time_frame>3 years</time_frame>
      <description>Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Risk of surgery on suspicion of acute appendicitis</measure>
      <time_frame>5 years</time_frame>
      <description>Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reintervention</measure>
      <time_frame>30 days</time_frame>
      <description>Laparoscopy or laparotomy due to complications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative complications</measure>
      <time_frame>30 days</time_frame>
      <description>Postoperative complications according to the 'Clavien-Dindo classification'</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay</measure>
      <time_frame>30 days</time_frame>
      <description>Time from index surgery to discharge</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1400</enrollment>
    <condition>Appendicitis Acute</condition>
    <arm_group>
      <arm_group_label>Diagnostic laparoscopy</arm_group_label>
      <description>Diagnostic laparoscopy on suspicion of acute appendicitis with normal intraoperative findings (including mesenteric adenitis).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Laparoscopic appendectomy</arm_group_label>
      <description>Laparoscopic appendectomy despite normal intraoperative findings (including mesenteric adenitis) and histopathology showing a normal appendix.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Laparoscopic appendectomy</intervention_name>
      <description>Laparoscopic appendectomy as performed as standard world wide. Division of the appendix with laparoscopic stapler.</description>
      <arm_group_label>Laparoscopic appendectomy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing diagnostic laparoscopy on suspicion of acute appendicitis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnostic laparoscopy with normal intraoperative findings (including mesenteric&#xD;
               adenitis&#xD;
  &#xD;
            -  Laparoscopic appendectomy and a histopathological normal appendix and otherwise normal&#xD;
               intraoperative findings (including mesenteric adenitis)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnostic laparoscopy with abnormal intraoperative findings.&#xD;
  &#xD;
            -  Laparoscopic appendectomy and a histopathological non-normal appendix.&#xD;
  &#xD;
            -  Laparoscopic appendectomy and a histopathological normal appendix and abnormal&#xD;
               intraoperative findings.&#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, Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>cabertelsen@gmail.com</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Copenhagen University Hospital - Bispebjerg</name>
        <address>
          <city>Copenhagen NV</city>
          <zip>2400</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Copenhagen University Hospital - Herlev</name>
        <address>
          <city>Herlev</city>
          <zip>2730</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Copenhagen University Hospital - North Zealand</name>
        <address>
          <city>Hillerød</city>
          <zip>3400</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Copenhagen University Hospital - Hvidovre</name>
        <address>
          <city>Hvidovre</city>
          <zip>2650</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <reference>
      <citation>Jaunoo SS, Hale AL, Masters JP, Jaunoo SR. An international survey of opinion regarding investigation of possible appendicitis and laparoscopic management of a macroscopically normal appendix. Ann R Coll Surg Engl. 2012 Oct;94(7):476-80. doi: 10.1308/003588412X13373405385377.</citation>
      <PMID>23031764</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>Bakker OJ, Go PM, Puylaert JB, Kazemier G, Heij HA; Werkgroep richtlijn Diagnostiek en behandeling van acute appendicitis. [Guideline on diagnosis and treatment of acute appendicitis: imaging prior to appendectomy is recommended]. Ned Tijdschr Geneeskd. 2010;154:A303. Dutch.</citation>
      <PMID>21262032</PMID>
    </reference>
    <reference>
      <citation>Lee M, Paavana T, Mazari F, Wilson TR. The morbidity of negative appendicectomy. Ann R Coll Surg Engl. 2014 Oct;96(7):517-20. doi: 10.1308/003588414X13946184903801.</citation>
      <PMID>25245730</PMID>
    </reference>
    <reference>
      <citation>Bijnen CL, Van Den Broek WT, Bijnen AB, De Ruiter P, Gouma DJ. Implications of removing a normal appendix. Dig Surg. 2003;20(2):115-21. doi: 10.1159/000069386.</citation>
      <PMID>12686778</PMID>
    </reference>
    <reference>
      <citation>Gough IR, Morris MI, Pertnikovs EI, Murray MR, Smith MB, Bestmann MS. Consequences of removal of a &quot;normal&quot; appendix. Med J Aust. 1983 Apr 16;1(8):370-2. doi: 10.5694/j.1326-5377.1983.tb99414.x.</citation>
      <PMID>6835144</PMID>
    </reference>
    <reference>
      <citation>Sorensen AK, Bang-Nielsen A, Levic-Souzani K, Pommergaard HC, Jorgensen AB, Tolstrup MB, Rud B, Kovacevic B, Bulut O. Readmission and reoperation rates following negative diagnostic laparoscopy for clinically suspected appendicitis: The &quot;normal&quot; appendix should not be removed - A retrospective cohort study. Int J Surg. 2019 Apr;64:1-4. doi: 10.1016/j.ijsu.2019.02.001. Epub 2019 Feb 12. Erratum In: Int J Surg. 2020 Jul;79:154.</citation>
      <PMID>30769215</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Laparoscopic appendectomy</keyword>
    <keyword>Normal findings</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000020
  org study id: LapApp
  nct id: NCT06000020
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Based on a regional cohort, this study we will try to demonstrate the superiority of routine
        laparoscopic appendectomy vs. leaving an intraoperative assessed normal appendix in situ in
        cases of normal findings at diagnostic laparoscopy. If routine laparoscopic appendectomy is
        not superior, we will recommend leaving the "normal" appendix in situ.
  The study is a retrospective cohort study with a superiority design. It will be carried out
        at the surgical departments of the four public university hospitals providing emergency
        surgical service to the entire population of 1,8 million in the Capital Region of Denmark.
  
        On March 17, 2017, a new electronic health record (EHR) had been implemented at three of the
        hospital, while it was implemented at Copenhagen University Hospital - Bispebjerg on May 20,
        2017. These dates mark the start of the inclusion period for each hospital, while the
        inclusion period ended April 1, 2021 for all four hospitals.
  
        The "snap boards" covering the relevant operation rooms at the four hospitals will be
        systematically review. For all cases, where diagnostic laparoscopy was performed on suspicion
        of acute appendicitis, the EHR will be reviewed.
  observational model: Cohort
  time perspective: Retrospective
  measure: Risk of surgery on suspicion of acute appendicitis
  time frame: 3 years
  description: Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis
  measure: Risk of surgery on suspicion of acute appendicitis
  time frame: 5 years
  description: Laparoscopy or laparotomy after surgery on suspicion of acute appendicitis
  measure: Reintervention
  time frame: 30 days
  description: Laparoscopy or laparotomy due to complications
  measure: Postoperative complications
  time frame: 30 days
  description: Postoperative complications according to the 'Clavien-Dindo classification'
  measure: Length of stay
  time frame: 30 days
  description: Time from index surgery to discharge
  arm group label: Diagnostic laparoscopy
  description: Diagnostic laparoscopy on suspicion of acute appendicitis with normal intraoperative findings (including mesenteric adenitis).
  arm group label: Laparoscopic appendectomy
  description: Laparoscopic appendectomy despite normal intraoperative findings (including mesenteric adenitis) and histopathology showing a normal appendix.
  intervention type: Procedure
  intervention name: Laparoscopic appendectomy
  description: Laparoscopic appendectomy as performed as standard world wide. Division of the appendix with laparoscopic stapler.
  arm group label: Laparoscopic appendectomy
  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, Ph.D.
  role: Study Chair
  affiliation: cabertelsen@gmail.com
  facility: 
  facility: 
  facility: 
  facility: 
  country: Denmark
  citation: Jaunoo SS, Hale AL, Masters JP, Jaunoo SR. An international survey of opinion regarding investigation of possible appendicitis and laparoscopic management of a macroscopically normal appendix. Ann R Coll Surg Engl. 2012 Oct;94(7):476-80. doi: 10.1308/003588412X13373405385377.
  PMID: 23031764
  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: Bakker OJ, Go PM, Puylaert JB, Kazemier G, Heij HA; Werkgroep richtlijn Diagnostiek en behandeling van acute appendicitis. [Guideline on diagnosis and treatment of acute appendicitis: imaging prior to appendectomy is recommended]. Ned Tijdschr Geneeskd. 2010;154:A303. Dutch.
  PMID: 21262032
  citation: Lee M, Paavana T, Mazari F, Wilson TR. The morbidity of negative appendicectomy. Ann R Coll Surg Engl. 2014 Oct;96(7):517-20. doi: 10.1308/003588414X13946184903801.
  PMID: 25245730
  citation: Bijnen CL, Van Den Broek WT, Bijnen AB, De Ruiter P, Gouma DJ. Implications of removing a normal appendix. Dig Surg. 2003;20(2):115-21. doi: 10.1159/000069386.
  PMID: 12686778
  citation: Gough IR, Morris MI, Pertnikovs EI, Murray MR, Smith MB, Bestmann MS. Consequences of removal of a "normal" appendix. Med J Aust. 1983 Apr 16;1(8):370-2. doi: 10.5694/j.1326-5377.1983.tb99414.x.
  PMID: 6835144
  citation: Sorensen AK, Bang-Nielsen A, Levic-Souzani K, Pommergaard HC, Jorgensen AB, Tolstrup MB, Rud B, Kovacevic B, Bulut O. Readmission and reoperation rates following negative diagnostic laparoscopy for clinically suspected appendicitis: The "normal" appendix should not be removed - A retrospective cohort study. Int J Surg. 2019 Apr;64:1-4. doi: 10.1016/j.ijsu.2019.02.001. Epub 2019 Feb 12. Erratum In: Int J Surg. 2020 Jul;79:154.
  PMID: 30769215
  responsible party type: Sponsor
  mesh term: Appendicitis
  sharing ipd: No