<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/NCT04486300</url>
  </required_header>
  <id_info>
    <org_study_id>100500323</org_study_id>
    <nct_id>NCT04486300</nct_id>
  </id_info>
  <brief_title>Seasonal Variations and Different Treatment Protocols OF Intussusception In Children:</brief_title>
  <official_title>Seasonal Variations and Different Treatment Protocols OF Intussusception In Children: Our Center Experience.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background: Intussusception remains a common cause of bowel obstruction in children and&#xD;
      results in significant morbidity and mortality if not promptly treated. There is a paucity of&#xD;
      prospective studies regarding childhood intussusception. This study describes the seasonal&#xD;
      variation and management outcomes of childhood intussusception.&#xD;
&#xD;
      METHODS: This was A prospective study of all patients admitted and treated for childhood&#xD;
      intussusception aged &lt; 12 year intussusception from January 2014 to December 2018 was&#xD;
      conducted in El-Minia University Pediatric surgery unit. Data about the ages of the patients,&#xD;
      sex, clinical presentation, duration of symptoms before presentation, mode of treatment,&#xD;
      outcome of treatment, and incidence of recurrence were recorded and analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective study from January 2014 to December 2018 was conducted in 470 cases in El-Minia&#xD;
      University Pediatric surgery unit. All pediatric patients (up to 14 years old) hospitalized&#xD;
      with diagnosis of bowel intussusception were included in the study. The clinical records&#xD;
      included: age, gender, signs, symptoms, and number of any previous episodes of&#xD;
      intussusception and their treatment, concomitant pathologies and intolerance, ultrasound&#xD;
      data, laboratory parameters and performed treatment.&#xD;
&#xD;
      An ultrasonography was performed when patients presented suspicion symptoms and signs of&#xD;
      intussusception, in order to confirm the diagnosis and exclude other causes. Diagnosis was&#xD;
      based on the presence of the &quot;target sign&quot; on vertical section on ultrasound images.&#xD;
      Collected data included location and diameter of the intussusception, free fluid in abdomen&#xD;
      and presence of visible pathological lead point. If diagnosis was confirmed, the management&#xD;
      and treatment depended on the patients' situation, in patients complaining of severe&#xD;
      dehydration, high grade fever and other signs of septicemia the conservative treatment was&#xD;
      contraindicated and direct surgical treatment was performed. For children in good general&#xD;
      conditions initial Pneumatic reduction under continuous imaging monitoring using a C-arm&#xD;
      device was attempted; if reduction failed or unstable vital signs were observed, enema was&#xD;
      discontinued and surgical management was proposed. If intussusception recurrence was observed&#xD;
      in the next hours, Pneumatic reduction was performed again whenever possible.&#xD;
&#xD;
      Treatment After fluid and electrolyte correction, Pneumatic reduction was performed by using&#xD;
      air through an 18 F urinary catheter applied to the rectum under continuous imaging guidance&#xD;
      by C-arm. With child in a supine position, a Foley catheter was introduced in the rectum and&#xD;
      maintained by inflating its balloon with 40 ml saline; the buttocks were joined with a band&#xD;
      aid in order to avoid leaks. The rectal cannula was connected to Sphygmomanometer inflatable&#xD;
      cuff initially about 80 mmHg increasing up to a maximum of 120. The passage of air into the&#xD;
      ileum through the ileocecal valve ensures successful reduction. No time limit was imposed on&#xD;
      the duration of the procedure; however, cessation of retrograde movement of the&#xD;
      intussusception for more than 15 minutes was regarded as a failed attempt. The procedure was&#xD;
      repeated 20 minutes later, with a maximum of 3 attempts.&#xD;
&#xD;
      All children were kept under medical supervision, no oral intake was permitted for the&#xD;
      following 24 hours and intravenously fluids and antibiotics were given. After 12 to 24 hours&#xD;
      ultrasonography was repeated to exclude early recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2014</start_date>
  <completion_date type="Actual">March 7, 2020</completion_date>
  <primary_completion_date type="Actual">December 13, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time of presentation</measure>
    <time_frame>2 years</time_frame>
    <description>Seasons with high presented cases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgery</measure>
    <time_frame>2 Years</time_frame>
    <description>If we needed Invasive Intervention or Classic reduction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">470</enrollment>
  <condition>Intussusception</condition>
  <arm_group>
    <arm_group_label>Season of presentation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Comparison of number of presented cases in each season</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical intervention of failed Pneumatic cases is done</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pneumatic reduction and Laparotomy</intervention_name>
    <description>Pneumatic reduction is the main intervention for suitable cases and If failed a laparotomy exploration and surgical reduction is done to save life</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients in the pediatric age group (&lt;14 years).&#xD;
&#xD;
          -  Proved diagnosis of acute intussusception.&#xD;
&#xD;
          -  Completion of patient's data in the medical records.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other concomitant disease.&#xD;
&#xD;
          -  Refused cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minia University</investigator_affiliation>
    <investigator_full_name>Alaa Ahmed ElSayed A. Moustafa</investigator_full_name>
    <investigator_title>Associate Professor of Pediatric Surgery</investigator_title>
  </responsible_party>
  <keyword>Intussusception, Pediatric surgery, Pneumoreduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intussusception</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>data will be available for 10 years</ipd_time_frame>
    <ipd_access_criteria>open Access Journal</ipd_access_criteria>
  </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/NCT04486300
org study id: 100500323
nct id: NCT04486300
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Intussusception remains a common cause of bowel obstruction in children and
      results in significant morbidity and mortality if not promptly treated. There is a paucity of
      prospective studies regarding childhood intussusception. This study describes the seasonal
      variation and management outcomes of childhood intussusception.

      METHODS: This was A prospective study of all patients admitted and treated for childhood
      intussusception aged < 12 year intussusception from January 2014 to December 2018 was
      conducted in El-Minia University Pediatric surgery unit. Data about the ages of the patients,
      sex, clinical presentation, duration of symptoms before presentation, mode of treatment,
      outcome of treatment, and incidence of recurrence were recorded and analyzed.
A prospective study from January 2014 to December 2018 was conducted in 470 cases in El-Minia
      University Pediatric surgery unit. All pediatric patients (up to 14 years old) hospitalized
      with diagnosis of bowel intussusception were included in the study. The clinical records
      included: age, gender, signs, symptoms, and number of any previous episodes of
      intussusception and their treatment, concomitant pathologies and intolerance, ultrasound
      data, laboratory parameters and performed treatment.

      An ultrasonography was performed when patients presented suspicion symptoms and signs of
      intussusception, in order to confirm the diagnosis and exclude other causes. Diagnosis was
      based on the presence of the "target sign" on vertical section on ultrasound images.
      Collected data included location and diameter of the intussusception, free fluid in abdomen
      and presence of visible pathological lead point. If diagnosis was confirmed, the management
      and treatment depended on the patients' situation, in patients complaining of severe
      dehydration, high grade fever and other signs of septicemia the conservative treatment was
      contraindicated and direct surgical treatment was performed. For children in good general
      conditions initial Pneumatic reduction under continuous imaging monitoring using a C-arm
      device was attempted; if reduction failed or unstable vital signs were observed, enema was
      discontinued and surgical management was proposed. If intussusception recurrence was observed
      in the next hours, Pneumatic reduction was performed again whenever possible.

      Treatment After fluid and electrolyte correction, Pneumatic reduction was performed by using
      air through an 18 F urinary catheter applied to the rectum under continuous imaging guidance
      by C-arm. With child in a supine position, a Foley catheter was introduced in the rectum and
      maintained by inflating its balloon with 40 ml saline; the buttocks were joined with a band
      aid in order to avoid leaks. The rectal cannula was connected to Sphygmomanometer inflatable
      cuff initially about 80 mmHg increasing up to a maximum of 120. The passage of air into the
      ileum through the ileocecal valve ensures successful reduction. No time limit was imposed on
      the duration of the procedure; however, cessation of retrograde movement of the
      intussusception for more than 15 minutes was regarded as a failed attempt. The procedure was
      repeated 20 minutes later, with a maximum of 3 attempts.

      All children were kept under medical supervision, no oral intake was permitted for the
      following 24 hours and intravenously fluids and antibiotics were given. After 12 to 24 hours
      ultrasonography was repeated to exclude early recurrence.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time of presentation
time frame: 2 years
description: Seasons with high presented cases
measure: Surgery
time frame: 2 Years
description: If we needed Invasive Intervention or Classic reduction
arm group label: Season of presentation
arm group type: No Intervention
description: Comparison of number of presented cases in each season
arm group label: Intervention
arm group type: Active Comparator
description: Surgical intervention of failed Pneumatic cases is done
intervention type: Procedure
intervention name: Pneumatic reduction and Laparotomy
description: Pneumatic reduction is the main intervention for suitable cases and If failed a laparotomy exploration and surgical reduction is done to save life
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Months
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Minia University
investigator full name: Alaa Ahmed ElSayed A. Moustafa
investigator title: Associate Professor of Pediatric Surgery
mesh term: Intussusception
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: data will be available for 10 years
ipd access criteria: open Access Journal