<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/NCT03280784</url>
  </required_header>
  <id_info>
    <org_study_id>AssiutU Pediatric hospital</org_study_id>
    <nct_id>NCT03280784</nct_id>
  </id_info>
  <brief_title>Clinical Audit on the Use of Upper Endoscopy in Assist University Children Hospital</brief_title>
  <acronym>CAOUOEUIAUCH</acronym>
  <official_title>Clinical Audit on the Use of Upper Gastrointestinal Endoscopy in Assiut University Children Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahmoud Mohammed Osman Ali</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assiut University</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>
      this protocol aides to evaluate:( 1)whether upper gastrointestinal endoscopy (UGE) is used&#xD;
      appropriately according to the Guideline on pediatric GI endoscopy [1] commissioned by the&#xD;
      European Society for Paediatric Gastroenterology Hepatology and Nutrition(ESPGHAN) and the&#xD;
      European Society of Gastrointestinal Endoscopy(ESGE). In our hospital setting and(2) whether&#xD;
      there is any relationship between appropriateness of gastrointestinal endoscopy and the&#xD;
      presence of lesions detected by endoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      gastrointestinal endoscopy is a safe and effective procedure. However,complications do exist&#xD;
      and procedure-related costs are significant The rapid escalation of the cost of medical care,&#xD;
      in the face of limited resources, is making the appropriateness of indications more and more&#xD;
      essential to the rational utilization of such resources.Upper Gastrointestinal (UGI)&#xD;
      endoscopy in the pediatric population has evolved during the last 30 years with an increasing&#xD;
      number of diagnostic and therapeutic applications.&#xD;
&#xD;
      years with an increasing number of diagnostic and therapeutic Technological improvements and&#xD;
      endoscopic devices have contributed to the evolution This prospective study is to determine&#xD;
      whether upper gastrointestinal endoscopy is used appropriately in our hospital setting&#xD;
      according to, the Guideline on pediatric GI endoscopy [1] commissioned by the European&#xD;
      Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and the European&#xD;
      Society of Gastrointestinal Endoscopy (ESGE). and whether the appropriateness of use Predicts&#xD;
      the probability of detecting significant lesions by endoscopy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>improve the use of upper gastrointestinal endoscopy in assiut university hospital of upper gastrointestinal endoscopy in assiut university children hospital</measure>
    <time_frame>One year</time_frame>
    <description>appropriateness&#xD;
This prospective study is to determine whether upper gastrointestinal endoscopy is used appropriately in our hospital setting according to, the Guideline on pediatric GI endoscopy [1] commissioned by the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and the European Society of Gastrointestinal Endoscopy (ESGE). and whether the appropriateness of use Predicts the probability of detecting significant lesions by endoscopy</description>
  </primary_outcome>
  <enrollment type="Actual">1</enrollment>
  <condition>Upper Gastrointestinal Endoscopy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        children admitted at assiut university hospital for upper gastrointestinal endoscopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Weight loss,&#xD;
&#xD;
        failure to thrive&#xD;
&#xD;
        Unexplained anemia&#xD;
&#xD;
        Abdominal pain with suspicion of an organic disease&#xD;
&#xD;
        Dysphagia or odynophagia&#xD;
&#xD;
        Caustic ingestion&#xD;
&#xD;
        Recurrent vomiting exclusion criteria&#xD;
&#xD;
        patients with perforated viscous&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>mahmoud mohammed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut university children hospital</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>November 8, 2020</last_update_submitted>
  <last_update_submitted_qc>November 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mahmoud Mohammed Osman Ali</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03280784
org study id: AssiutU Pediatric hospital
nct id: NCT03280784
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
this protocol aides to evaluate:( 1)whether upper gastrointestinal endoscopy (UGE) is used
      appropriately according to the Guideline on pediatric GI endoscopy [1] commissioned by the
      European Society for Paediatric Gastroenterology Hepatology and Nutrition(ESPGHAN) and the
      European Society of Gastrointestinal Endoscopy(ESGE). In our hospital setting and(2) whether
      there is any relationship between appropriateness of gastrointestinal endoscopy and the
      presence of lesions detected by endoscopy.
gastrointestinal endoscopy is a safe and effective procedure. However,complications do exist
      and procedure-related costs are significant The rapid escalation of the cost of medical care,
      in the face of limited resources, is making the appropriateness of indications more and more
      essential to the rational utilization of such resources.Upper Gastrointestinal (UGI)
      endoscopy in the pediatric population has evolved during the last 30 years with an increasing
      number of diagnostic and therapeutic applications.

      years with an increasing number of diagnostic and therapeutic Technological improvements and
      endoscopic devices have contributed to the evolution This prospective study is to determine
      whether upper gastrointestinal endoscopy is used appropriately in our hospital setting
      according to, the Guideline on pediatric GI endoscopy [1] commissioned by the European
      Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and the European
      Society of Gastrointestinal Endoscopy (ESGE). and whether the appropriateness of use Predicts
      the probability of detecting significant lesions by endoscopy
observational model: Case-Only
time perspective: Prospective
measure: improve the use of upper gastrointestinal endoscopy in assiut university hospital of upper gastrointestinal endoscopy in assiut university children hospital
time frame: One year
description: appropriateness
This prospective study is to determine whether upper gastrointestinal endoscopy is used appropriately in our hospital setting according to, the Guideline on pediatric GI endoscopy [1] commissioned by the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and the European Society of Gastrointestinal Endoscopy (ESGE). and whether the appropriateness of use Predicts the probability of detecting significant lesions by endoscopy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
last name: mahmoud mohammed, MD
role: Principal Investigator
affiliation: Assiut
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Mahmoud Mohammed Osman Ali
investigator title: principle investigator