<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/NCT03248102</url>
  </required_header>
  <id_info>
    <org_study_id>PS15/261</org_study_id>
    <nct_id>NCT03248102</nct_id>
  </id_info>
  <brief_title>Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)</brief_title>
  <acronym>FETOR</acronym>
  <official_title>Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Leeds Teaching Hospitals NHS Trust</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>
      Acute appendicitis is the most common surgical emergency in childhood. Despite access to&#xD;
      current diagnostic modalities, diagnosis may be challenging since the child may have&#xD;
      difficulty in articulating symptoms. Additionally there is a high frequency of atypical&#xD;
      presentation and rapid progression. Delayed diagnosis in children is reported as being up to&#xD;
      60%. Delayed diagnosis &gt;48hr increases the perforation rate from 21% to 71%. Around 20% of&#xD;
      children presenting with appendicitis have perforated by the time they come to surgery.&#xD;
&#xD;
      Appendix perforation is associated with a prolonged hospital stay and increased cost. Once&#xD;
      perforated, major complication rates increase from 1.2% to 6.4%, median bed stay increases&#xD;
      from 2 to 6 days and hospitalisation costs are estimated at US $33,348.&#xD;
&#xD;
      Conversely, a false positive diagnosis leads to unnecessary surgery in 12%. It has been&#xD;
      suggested that only 35% of surgical referrals with possible appendicitis actually need&#xD;
      surgery thus impacting on resource use.&#xD;
&#xD;
      A reliable test, especially if painless, would be very useful. If positive the child could&#xD;
      undergo early appendicectomy in expectation of a reduction in the perforation rate (and,&#xD;
      therefore, reduction in hospital stay). If negative the child could be discharged home&#xD;
      safely. No adequate biomarker has been identified.&#xD;
&#xD;
      Technology already exists to detect changes in Volatile Organic Compounds (VOC) in gases. VOC&#xD;
      analysis is already used commercially to identify disease processes in animals and crops.&#xD;
      Although VOC has been previously used to detect human diseases, it has never been used to&#xD;
      look for changes in the composition of breath in appendicitis.&#xD;
&#xD;
      The investigators hypothesise that the composition of VOC's in children with appendicitis&#xD;
      will differ from those without. The investigators anticipate these differences will be of&#xD;
      diagnostic and prognostic value in clinical practice. The feasibility of collecting breath&#xD;
      samples from children with possible appendicitis to allow VOC testing has not been examined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 9, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Breath collection for analysis</measure>
    <time_frame>3 minutes</time_frame>
    <description>Collect breath from children with abdominal pain meeting inclusion criteria assess ment to changes in Volatile Organic Compounds (VOC)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Appendicitis</condition>
  <arm_group>
    <arm_group_label>Patients with suspected appendicitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with suspected appendicitis Aged 5 and up to their 16th birthday on arrival to A&amp;E</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blowing into the mouthpiece</intervention_name>
    <description>Blowing into the mouthpiece of diagnostic device</description>
    <arm_group_label>Patients with suspected appendicitis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with suspected appendicitis&#xD;
&#xD;
          -  Aged 5 and up to their 16th birthday on arrival to A&amp;E&#xD;
&#xD;
          -  Patients referred to the Paediatric surgical team that have presented to the Leeds&#xD;
             General Infirmary through A&amp;E, the Children's Assessment Unit, or via direct referral&#xD;
             from another team or hospital.&#xD;
&#xD;
          -  Consecutive presentations who can have some or all of VOC sampling during working&#xD;
             week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known alternative cause of abdominal pain (e.g. known Inflammatory Bowel&#xD;
             Disease)&#xD;
&#xD;
          -  Patients who are both admitted and discharged when no researcher is available&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>November 4, 2019</last_update_submitted>
  <last_update_submitted_qc>November 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>paediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03248102
org study id: PS15/261
nct id: NCT03248102
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute appendicitis is the most common surgical emergency in childhood. Despite access to
      current diagnostic modalities, diagnosis may be challenging since the child may have
      difficulty in articulating symptoms. Additionally there is a high frequency of atypical
      presentation and rapid progression. Delayed diagnosis in children is reported as being up to
      60%. Delayed diagnosis >48hr increases the perforation rate from 21% to 71%. Around 20% of
      children presenting with appendicitis have perforated by the time they come to surgery.

      Appendix perforation is associated with a prolonged hospital stay and increased cost. Once
      perforated, major complication rates increase from 1.2% to 6.4%, median bed stay increases
      from 2 to 6 days and hospitalisation costs are estimated at US $33,348.

      Conversely, a false positive diagnosis leads to unnecessary surgery in 12%. It has been
      suggested that only 35% of surgical referrals with possible appendicitis actually need
      surgery thus impacting on resource use.

      A reliable test, especially if painless, would be very useful. If positive the child could
      undergo early appendicectomy in expectation of a reduction in the perforation rate (and,
      therefore, reduction in hospital stay). If negative the child could be discharged home
      safely. No adequate biomarker has been identified.

      Technology already exists to detect changes in Volatile Organic Compounds (VOC) in gases. VOC
      analysis is already used commercially to identify disease processes in animals and crops.
      Although VOC has been previously used to detect human diseases, it has never been used to
      look for changes in the composition of breath in appendicitis.

      The investigators hypothesise that the composition of VOC's in children with appendicitis
      will differ from those without. The investigators anticipate these differences will be of
      diagnostic and prognostic value in clinical practice. The feasibility of collecting breath
      samples from children with possible appendicitis to allow VOC testing has not been examined.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Breath collection for analysis
time frame: 3 minutes
description: Collect breath from children with abdominal pain meeting inclusion criteria assess ment to changes in Volatile Organic Compounds (VOC)
arm group label: Patients with suspected appendicitis
arm group type: Experimental
description: Patients with suspected appendicitis Aged 5 and up to their 16th birthday on arrival to A&E
intervention type: Diagnostic Test
intervention name: Blowing into the mouthpiece
description: Blowing into the mouthpiece of diagnostic device
arm group label: Patients with suspected appendicitis
criteria: 
gender: All
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Appendicitis