<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/NCT04480983</url>
  </required_header>
  <id_info>
    <org_study_id>MDCT in acute abdomen</org_study_id>
    <nct_id>NCT04480983</nct_id>
  </id_info>
  <brief_title>Role of Multidetector Computerized Tomography (MDCT) in Diagnosis of Non Traumatic Acute Abdomen in Pediatric Age Group.</brief_title>
  <official_title>Role of Multidetector Computerized Tomography (MDCT) in Diagnosis of Non Traumatic Acute Abdomen in Pediatric Age Group.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amal Fathy Abo Elgarad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      To evaluate the role of MDCT in diagnosis of non traumatic causes of acute abdomen in&#xD;
      pediatric patients with clinical and surgical correlation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute abdominal pain is a common presenting symptom to the pediatric emergency department&#xD;
      (1). The causes of the acute abdomen in pediatric patients are numerous, and diagnosis is&#xD;
      often delayed due to misleading signs and symptoms.&#xD;
&#xD;
      Conditions that can be manifested by acute abdominal pain vary in incidence with age and sex.&#xD;
      Classification of acute abdominal pain based on age is one adapted approach to narrow the&#xD;
      differential diagnosis, which can guide selection of appropriate diagnostic tests, imaging,&#xD;
      and definitive treatment.&#xD;
&#xD;
      While most of the emergency visits presenting with acute abdominal pain are self-limited and&#xD;
      benign medical diagnoses, a surgical etiology may be present in up to 20%.(7) In nontraumatic&#xD;
      cases of an acute abdomen below 1 year of age, the most common surgical etiology was reported&#xD;
      to be incarcerated inguinal hernia (45.1%), followed by intussusception (41.9%). These&#xD;
      etiologies were uncommon in school-age and adolescent children. In children above 1 year of&#xD;
      age, the most common causes of acute surgical diagnoses have been reported to be acute&#xD;
      appendicitis , incarcerated hernia, intussusception, intestinal obstruction, and ovarian&#xD;
      torsion.&#xD;
&#xD;
      CT scanning provides very detailed images of many types of tissue as well as the lungs,&#xD;
      bones, and blood vessels.CT scanning is painless, non invasive and accurate. CT has been&#xD;
      shown to be a cost-effective imaging tool for a wide range of clinical problems. CT is less&#xD;
      sensitive to patient movement than MRI.&#xD;
&#xD;
      The use of pediatric CT, which is a valuable imaging tool, has been increasing rapidly.&#xD;
      However, because of the potential for increased radiation exposure to children undergoing&#xD;
      these scans, pediatric CT is a public health concern CT can be a life saving tool for&#xD;
      diagnosing illness and injury in children. For an individual child, the risks of CT are small&#xD;
      and the individual risk-benefit balance favors the benefit when used appropriately.&#xD;
&#xD;
      Despite the many benefits of CT, a disadvantage is the inevitable radiation exposure.&#xD;
&#xD;
      Radiologists should continually think about reducing exposure as low as reasonably achievable&#xD;
      by using exposure settings customized for children. (8,9) There has been revolutionary&#xD;
      development in multidetector CT (MDCT) technology that has contributed to a substantial&#xD;
      increase in its diagnostic applications and accuracy, even in children. However, a major&#xD;
      drawback of MDCT is the use of ionizing radiation and, consequently, the risks of&#xD;
      radiation-induced side effects.&#xD;
&#xD;
      It is generally believed that there is a linear-no threshold risk relationship. We should act&#xD;
      as if low-dose radiation may well cause secondary cancer and reduce the medical radiation&#xD;
      exposure to children as much as possible, the &quot;as low as reasonably achievable&quot; (ALARA)&#xD;
      concept.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2021</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the role of ultrasound for diagnosis of acute abdominal pain in pediatric.</measure>
    <time_frame>Baseline</time_frame>
    <description>To evaluate the clinical examination and the role of ultrasound as a primary tool for diagnosis of non traumatic acute abdominal pain in pediatric.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the multidetector CT.</measure>
    <time_frame>Baseline</time_frame>
    <description>Confirmation of the findings achieved by the primary tools by using the multidetector CT.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Acute Abdomen in Children</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Multidetector Computerized Tomography (MDCT)</intervention_name>
    <description>To evaluate the role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric patients with clinical and surgical correlation.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric&#xD;
        patients with clinical and surgical correlation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presented by acute abdominal pain from first day of life till fifteen years&#xD;
             old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients above 15 years old.&#xD;
&#xD;
          -  Patients with traumatic cause of acute abdominal pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>15 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Amal Fathy</last_name>
    <phone>002/1069363096</phone>
    <email>amalfathy1406@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hasan Ibrahim, Professor</last_name>
    <phone>002/1006209584</phone>
    <email>hasanibrahim48@yahoo.com</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Nievelstein RA, van Dam IM, van der Molen AJ. Multidetector CT in children: current concepts and dose reduction strategies. Pediatr Radiol. 2010 Aug;40(8):1324-44. doi: 10.1007/s00247-010-1714-7. Epub 2010 Jun 10.</citation>
    <PMID>20535463</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Amal Fathy Abo Elgarad</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdomen, Acute</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/NCT04480983
org study id: MDCT in acute abdomen
nct id: NCT04480983
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the role of MDCT in diagnosis of non traumatic causes of acute abdomen in
      pediatric patients with clinical and surgical correlation.
Acute abdominal pain is a common presenting symptom to the pediatric emergency department
      (1). The causes of the acute abdomen in pediatric patients are numerous, and diagnosis is
      often delayed due to misleading signs and symptoms.

      Conditions that can be manifested by acute abdominal pain vary in incidence with age and sex.
      Classification of acute abdominal pain based on age is one adapted approach to narrow the
      differential diagnosis, which can guide selection of appropriate diagnostic tests, imaging,
      and definitive treatment.

      While most of the emergency visits presenting with acute abdominal pain are self-limited and
      benign medical diagnoses, a surgical etiology may be present in up to 20%.(7) In nontraumatic
      cases of an acute abdomen below 1 year of age, the most common surgical etiology was reported
      to be incarcerated inguinal hernia (45.1%), followed by intussusception (41.9%). These
      etiologies were uncommon in school-age and adolescent children. In children above 1 year of
      age, the most common causes of acute surgical diagnoses have been reported to be acute
      appendicitis , incarcerated hernia, intussusception, intestinal obstruction, and ovarian
      torsion.

      CT scanning provides very detailed images of many types of tissue as well as the lungs,
      bones, and blood vessels.CT scanning is painless, non invasive and accurate. CT has been
      shown to be a cost-effective imaging tool for a wide range of clinical problems. CT is less
      sensitive to patient movement than MRI.

      The use of pediatric CT, which is a valuable imaging tool, has been increasing rapidly.
      However, because of the potential for increased radiation exposure to children undergoing
      these scans, pediatric CT is a public health concern CT can be a life saving tool for
      diagnosing illness and injury in children. For an individual child, the risks of CT are small
      and the individual risk-benefit balance favors the benefit when used appropriately.

      Despite the many benefits of CT, a disadvantage is the inevitable radiation exposure.

      Radiologists should continually think about reducing exposure as low as reasonably achievable
      by using exposure settings customized for children. (8,9) There has been revolutionary
      development in multidetector CT (MDCT) technology that has contributed to a substantial
      increase in its diagnostic applications and accuracy, even in children. However, a major
      drawback of MDCT is the use of ionizing radiation and, consequently, the risks of
      radiation-induced side effects.

      It is generally believed that there is a linear-no threshold risk relationship. We should act
      as if low-dose radiation may well cause secondary cancer and reduce the medical radiation
      exposure to children as much as possible, the "as low as reasonably achievable" (ALARA)
      concept.
observational model: Other
time perspective: Cross-Sectional
measure: the role of ultrasound for diagnosis of acute abdominal pain in pediatric.
time frame: Baseline
description: To evaluate the clinical examination and the role of ultrasound as a primary tool for diagnosis of non traumatic acute abdominal pain in pediatric.
measure: the multidetector CT.
time frame: Baseline
description: Confirmation of the findings achieved by the primary tools by using the multidetector CT.
intervention type: Device
intervention name: Multidetector Computerized Tomography (MDCT)
description: To evaluate the role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric patients with clinical and surgical correlation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 15 Years
last name: Amal Fathy
phone: 002/1069363096
email: amalfathy1406@yahoo.com
last name: Hasan Ibrahim, Professor
phone: 002/1006209584
email: hasanibrahim48@yahoo.com
citation: Nievelstein RA, van Dam IM, van der Molen AJ. Multidetector CT in children: current concepts and dose reduction strategies. Pediatr Radiol. 2010 Aug;40(8):1324-44. doi: 10.1007/s00247-010-1714-7. Epub 2010 Jun 10.
PMID: 20535463
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Amal Fathy Abo Elgarad
investigator title: doctor
mesh term: Abdomen, Acute