<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/NCT03259048</url>
  </required_header>
  <id_info>
    <org_study_id>Assiut University Hospitals</org_study_id>
    <nct_id>NCT03259048</nct_id>
  </id_info>
  <brief_title>Role of Ultrasound in Diagnosis of Acute Abdomen in Pediatric Group</brief_title>
  <official_title>Role of Ultrasound in Diagnosis of Acute Abdomen in Pediatric Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Acute abdomen can be defined as &quot;A syndrome induced by wide variety of pathological&#xD;
      conditions that require emergent medical or more often surgical management&quot; [1].There are a&#xD;
      plethora of causes that can lead to acute abdomen in children, they vary depending on the&#xD;
      ages of the children and can be divided into diseases that can be treated with medical care&#xD;
      and those in which emergency surgical intervention must be considered [2]. Ultrasonography is&#xD;
      the initial choice in the diagnosis of the different causes of acute abdomen in children [3,&#xD;
      4]. It is very useful as it is non-invasive, cost- effective, repetitive, with no radiation&#xD;
      exposure, as good as laparoscopy, can be done even in patients with scarred abdomen [5].&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -Patient preparation:&#xD;
&#xD;
        -  No specific preparation is needed.&#xD;
&#xD;
        -  Demographic data including age, sex, detailed history, clinical presentation, laboratory&#xD;
           tests, and data of any other investigations or operation will be obtained.&#xD;
&#xD;
        -  Clinical examination will be done in emergency pediatric unit for provisional diagnosis.&#xD;
&#xD;
           -Study instruments:• Patients will examined by Grey-Scale Ultrasonography (U/S) combined&#xD;
           with Color Doppler Ultrasonography (CDUS).&#xD;
&#xD;
           3-Technique of examination&#xD;
&#xD;
        -  will be in supine position.&#xD;
&#xD;
        -  Patient First examination of whole abdomen will be done by Grey -Scale U/S using both&#xD;
           3.5 MHZ and 7.5 MHZ transducers .It will be done in both longitudinal ( parallel to long&#xD;
           axis of the patient ) and transverse ( perpendicular to long axis of the patient )&#xD;
           orientation .&#xD;
&#xD;
        -  Then finally examination by Color Doppler US will be done for assessment of organ&#xD;
           perfusion and diagnosing inflammation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</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>efficacy of ultrasound in diagnosis of acute abdomen</measure>
    <time_frame>2 years</time_frame>
    <description>efficacy of ultrasound in diagnosis of acute abdomen</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ultra Sound in Diagnosis of Acute Abdomen in Pediatric Group</condition>
  <arm_group>
    <arm_group_label>pediatric group</arm_group_label>
    <description>pediatric group from age of one day to eighteen years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Abdominal ultrasound</intervention_name>
    <description>Abdominal ultrasound will be used in the diagnosis of acute abdomen in pediatric group.</description>
    <arm_group_label>pediatric group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients referred from the emergency Pediatric Unit for the assessment of the cause of&#xD;
        acute abdomen from age of 1 day to 18 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  -In this study, 100 patients referred from the emergency Pediatric Unit for the&#xD;
             assessment of the cause of acute abdomen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Patients of age group above 18 years&#xD;
&#xD;
          -  Patients with trauma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>mohamed abdelwahab</last_name>
    <phone>01016307405</phone>
    <email>mohmed_abdelwahab1011@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mohamed abdelwahab</last_name>
    <phone>01016307405</phone>
    <email>mohmed_abdelwaab1011@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 19, 2017</last_update_submitted>
  <last_update_submitted_qc>August 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>mohmed abdelwahab</investigator_full_name>
    <investigator_title>Resident of Radiology Department - Assiut University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
    <mesh_term>Abdomen, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03259048
org study id: Assiut University Hospitals
nct id: NCT03259048
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute abdomen can be defined as "A syndrome induced by wide variety of pathological
      conditions that require emergent medical or more often surgical management" [1].There are a
      plethora of causes that can lead to acute abdomen in children, they vary depending on the
      ages of the children and can be divided into diseases that can be treated with medical care
      and those in which emergency surgical intervention must be considered [2]. Ultrasonography is
      the initial choice in the diagnosis of the different causes of acute abdomen in children [3,
      4]. It is very useful as it is non-invasive, cost- effective, repetitive, with no radiation
      exposure, as good as laparoscopy, can be done even in patients with scarred abdomen [5].
-Patient preparation:

        -  No specific preparation is needed.

        -  Demographic data including age, sex, detailed history, clinical presentation, laboratory
           tests, and data of any other investigations or operation will be obtained.

        -  Clinical examination will be done in emergency pediatric unit for provisional diagnosis.

           -Study instruments:• Patients will examined by Grey-Scale Ultrasonography (U/S) combined
           with Color Doppler Ultrasonography (CDUS).

           3-Technique of examination

        -  will be in supine position.

        -  Patient First examination of whole abdomen will be done by Grey -Scale U/S using both
           3.5 MHZ and 7.5 MHZ transducers .It will be done in both longitudinal ( parallel to long
           axis of the patient ) and transverse ( perpendicular to long axis of the patient )
           orientation .

        -  Then finally examination by Color Doppler US will be done for assessment of organ
           perfusion and diagnosing inflammation.
observational model: Cohort
time perspective: Prospective
measure: efficacy of ultrasound in diagnosis of acute abdomen
time frame: 2 years
description: efficacy of ultrasound in diagnosis of acute abdomen
arm group label: pediatric group
description: pediatric group from age of one day to eighteen years.
intervention type: Diagnostic Test
intervention name: Abdominal ultrasound
description: Abdominal ultrasound will be used in the diagnosis of acute abdomen in pediatric group.
arm group label: pediatric group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
healthy volunteers: No
last name: mohamed abdelwahab
phone: 01016307405
email: mohmed_abdelwahab1011@yahoo.com
last name: mohamed abdelwahab
phone: 01016307405
email: mohmed_abdelwaab1011@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: mohmed abdelwahab
investigator title: Resident of Radiology Department - Assiut University
mesh term: Disease
mesh term: Abdomen, Acute
sharing ipd: No