<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/NCT04472052</url>
  </required_header>
  <id_info>
    <org_study_id>AZ: 324/2020BO2</org_study_id>
    <nct_id>NCT04472052</nct_id>
  </id_info>
  <brief_title>Frequency of Perforated Appendicitis in Times of COVID-19</brief_title>
  <official_title>Incidence of Perforated Appendicitis in Times of Corona Crisis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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>
      Appendicitis is one of the most common clinical conditions in general surgery. The diagnosis&#xD;
      is usually made from clinical examination, imaging (sonography or CT) and laboratory&#xD;
      parameters. The laparoscopic appendectomy without drainage has established as the gold&#xD;
      standard. Patients usually leave the hospital two days after surgery.&#xD;
&#xD;
      In times of corona crisis, patients are unsure to visit the hospital because of fear of&#xD;
      infection with SARS-CoV-2. A higher incidence of perforated appendicitis could be an&#xD;
      indicator for fear-related delay of going to the hospital.&#xD;
&#xD;
      Methods: Investigators performed a retrospective analysis on the incidence of perforated&#xD;
      appendicitis in a 10-week interval (mid-March to end of May) of the years 2018, 2019 and 2020&#xD;
      to evaluate possible changes in times of corona crisis. Intraoperative findings, procedures,&#xD;
      complications and the length of hospital stay were considered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The local ethics committee of the University Hospital of Tübingen, Germany, approved this&#xD;
      study (AZ: 324/2020BO2). All patients treated for acute appendicitis in a ten week period&#xD;
      from 16th of March to 31th of May in 2018, 2019 and 2020 were considered for the study.&#xD;
      Investigators analysed the frequency of perforated appendicitis in the periods indicated.&#xD;
      Informed consent was obtained from all individual participants. Patient's records as well as&#xD;
      database were analyzed for therapy specific items.&#xD;
&#xD;
      Definition Perforation: Perforated appendicitis was defined as described perforation in the&#xD;
      surgical or pathological results.&#xD;
&#xD;
      Delay between onset of symptoms and first presentation at the hospital: Patient's records&#xD;
      were proved for self-declaration about the start of symptoms&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2020</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>rate of perforated appendicitis</measure>
    <time_frame>10 weeks from 16th of March to 31th of May</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">143</enrollment>
  <condition>Perforated Appendicitis</condition>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Appendectomy</arm_group_label>
    <description>Patients who required appendectomy for suspected acute appendicitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>appendectomy</intervention_name>
    <description>Surgical standard treatment for acute appendicitis All patients receive preoperative single-shot antibiosis, usually 2000 mg cefotaxime combined 500 mg metronidazole. Appendectomy is performed usually within 24 h of admission in patients with acute appendicitis. The laparoscopic appendectomy using the 3-trocar technique represents the surgical standard. In uncomplicated or non-perforated appendicitis, drainage is generally not required. Wounds are closed intra-cutaneous with absorbable sutures. Patients without postoperative complications are discharged home two days after surgery.</description>
    <arm_group_label>Appendectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with acute appendicitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with acute appendicitis older than 16 years&#xD;
&#xD;
          -  appendectomy in time frame 16th of march to 30th of May in the Years 2018, 2019 and&#xD;
             2020&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with acute appendicitis younger than 16 years&#xD;
&#xD;
          -  appendectomy not in the named time frames&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute appendicitis, COVID-19</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>
    <ipd_description>Researchers could send a request for the IPD to the investigators and will receive the required data.</ipd_description>
  </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/NCT04472052
org study id: AZ: 324/2020BO2
nct id: NCT04472052
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Appendicitis is one of the most common clinical conditions in general surgery. The diagnosis
      is usually made from clinical examination, imaging (sonography or CT) and laboratory
      parameters. The laparoscopic appendectomy without drainage has established as the gold
      standard. Patients usually leave the hospital two days after surgery.

      In times of corona crisis, patients are unsure to visit the hospital because of fear of
      infection with SARS-CoV-2. A higher incidence of perforated appendicitis could be an
      indicator for fear-related delay of going to the hospital.

      Methods: Investigators performed a retrospective analysis on the incidence of perforated
      appendicitis in a 10-week interval (mid-March to end of May) of the years 2018, 2019 and 2020
      to evaluate possible changes in times of corona crisis. Intraoperative findings, procedures,
      complications and the length of hospital stay were considered.
The local ethics committee of the University Hospital of Tübingen, Germany, approved this
      study (AZ: 324/2020BO2). All patients treated for acute appendicitis in a ten week period
      from 16th of March to 31th of May in 2018, 2019 and 2020 were considered for the study.
      Investigators analysed the frequency of perforated appendicitis in the periods indicated.
      Informed consent was obtained from all individual participants. Patient's records as well as
      database were analyzed for therapy specific items.

      Definition Perforation: Perforated appendicitis was defined as described perforation in the
      surgical or pathological results.

      Delay between onset of symptoms and first presentation at the hospital: Patient's records
      were proved for self-declaration about the start of symptoms
observational model: Cohort
time perspective: Other
measure: rate of perforated appendicitis
time frame: 10 weeks from 16th of March to 31th of May
arm group label: Appendectomy
description: Patients who required appendectomy for suspected acute appendicitis
intervention type: Other
intervention name: appendectomy
description: Surgical standard treatment for acute appendicitis All patients receive preoperative single-shot antibiosis, usually 2000 mg cefotaxime combined 500 mg metronidazole. Appendectomy is performed usually within 24 h of admission in patients with acute appendicitis. The laparoscopic appendectomy using the 3-trocar technique represents the surgical standard. In uncomplicated or non-perforated appendicitis, drainage is generally not required. Wounds are closed intra-cutaneous with absorbable sutures. Patients without postoperative complications are discharged home two days after surgery.
arm group label: Appendectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Appendicitis
sharing ipd: No
ipd description: Researchers could send a request for the IPD to the investigators and will receive the required data.