<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/NCT04454320</url>
  </required_header>
  <id_info>
    <org_study_id>intussusception in children</org_study_id>
    <nct_id>NCT04454320</nct_id>
  </id_info>
  <brief_title>Seasonal Variations and Different Treatment Protocols of Intussusception in Children: Our Centers Experiences</brief_title>
  <official_title>Seasonal Variations and Different Treatment Protocols of Intussusception in Children: Our Centers Experiences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia 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>
      Intussusception remains a common cause of bowel obstruction in children and results in&#xD;
      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;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intussusception is the invagination of a segment of bowel into an adjacent segment resulting&#xD;
      into an intestinal obstruction. It is the most common acquired cause of intestinal&#xD;
      obstruction in children aged four months to two years with a peak of incidence between four&#xD;
      and nine months of age. Etiology of intussusception is reported to be idiopathic in about 90%&#xD;
      of cases and rarely is it associated with pathological lead points such as Meckel's&#xD;
      diverticulum, appendix, solid bowel lesions, intestinal polyp, and intestinal lymphoma. It is&#xD;
      an occlusive-strangulation type of intestinal obstruction, and all necessary measures should&#xD;
      be taken early to ensure prompt diagnosis and treatment to avoid ischaemia and necrosis of&#xD;
      bowel. The term comes from two Latin words, intus, which means &quot;inside&quot; and suscipere, which&#xD;
      means &quot;to receive&quot;. It has been reported in neonates and adults . The ancient Greeks, treated&#xD;
      intestinal obstruction with enema or insufflations of air into the anus. Abdominal pain,&#xD;
      vomiting and blood in stools are the classic triad and are uncommon and seen in less than&#xD;
      one-third of the children affected. Cases often present with non-specific symptoms, including&#xD;
      vomiting, pain, irritability, decreased appetite and lethargy, and this may render diagnosis&#xD;
      of intussusception difficult. Abdominal ultrasound is considered the standard choice for its&#xD;
      diagnosis. Non-surgical management with Pneumatic reduction (PR) by air, hydrostatic&#xD;
      reduction by saline or contrast enema is the best procedure.Surgical management by&#xD;
      exploratory laparotomy with simple reduction while some cases may require a bowel resection&#xD;
      and reanastomosis for gangrenous bowel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>the seasonal variation and management outcomes of childhood intussusception.</measure>
    <time_frame>2 years</time_frame>
    <description>To evaluate the peak of months recorded to have cases with intussusception in 2 pediatric surgery centers across Egypt To evaluate the different modes of management of intussusception used in our centers.</description>
  </primary_outcome>
  <enrollment type="Anticipated">470</enrollment>
  <condition>Intussusception</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>INTUSSUSCEPTION IN CHILDREN</intervention_name>
    <description>the seasonal variation and management outcomes of childhood intussusception.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All pediatric patients (up to 14 years old) hospitalized with diagnosis of bowel&#xD;
        intussusception were included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria: The verified diagnosis of intussusceptions in patients by clinical&#xD;
             examination and ultrasonography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were excluded if the diagnosis of intussusceptions was not validated or&#xD;
             patients who were above 12 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Lehnert T, Sorge I, Till H, Rolle U. Intussusception in children--clinical presentation, diagnosis and management. Int J Colorectal Dis. 2009 Oct;24(10):1187-92. doi: 10.1007/s00384-009-0730-2. Epub 2009 May 6.</citation>
    <PMID>19418060</PMID>
  </results_reference>
  <results_reference>
    <citation>Parashar UD, Holman RC, Cummings KC, Staggs NW, Curns AT, Zimmerman CM, Kaufman SF, Lewis JE, Vugia DJ, Powell KE, Glass RI. Trends in intussusception-associated hospitalizations and deaths among US infants. Pediatrics. 2000 Dec;106(6):1413-21. doi: 10.1542/peds.106.6.1413.</citation>
    <PMID>11099597</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minia University</investigator_affiliation>
    <investigator_full_name>Alaa A.E. Moustafa, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intussusception</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/NCT04454320
org study id: intussusception in children
nct id: NCT04454320
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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
Intussusception is the invagination of a segment of bowel into an adjacent segment resulting
      into an intestinal obstruction. It is the most common acquired cause of intestinal
      obstruction in children aged four months to two years with a peak of incidence between four
      and nine months of age. Etiology of intussusception is reported to be idiopathic in about 90%
      of cases and rarely is it associated with pathological lead points such as Meckel's
      diverticulum, appendix, solid bowel lesions, intestinal polyp, and intestinal lymphoma. It is
      an occlusive-strangulation type of intestinal obstruction, and all necessary measures should
      be taken early to ensure prompt diagnosis and treatment to avoid ischaemia and necrosis of
      bowel. The term comes from two Latin words, intus, which means "inside" and suscipere, which
      means "to receive". It has been reported in neonates and adults . The ancient Greeks, treated
      intestinal obstruction with enema or insufflations of air into the anus. Abdominal pain,
      vomiting and blood in stools are the classic triad and are uncommon and seen in less than
      one-third of the children affected. Cases often present with non-specific symptoms, including
      vomiting, pain, irritability, decreased appetite and lethargy, and this may render diagnosis
      of intussusception difficult. Abdominal ultrasound is considered the standard choice for its
      diagnosis. Non-surgical management with Pneumatic reduction (PR) by air, hydrostatic
      reduction by saline or contrast enema is the best procedure.Surgical management by
      exploratory laparotomy with simple reduction while some cases may require a bowel resection
      and reanastomosis for gangrenous bowel.
observational model: Cohort
time perspective: Prospective
measure: the seasonal variation and management outcomes of childhood intussusception.
time frame: 2 years
description: To evaluate the peak of months recorded to have cases with intussusception in 2 pediatric surgery centers across Egypt To evaluate the different modes of management of intussusception used in our centers.
intervention type: Other
intervention name: INTUSSUSCEPTION IN CHILDREN
description: the seasonal variation and management outcomes of childhood intussusception.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: No
citation: Lehnert T, Sorge I, Till H, Rolle U. Intussusception in children--clinical presentation, diagnosis and management. Int J Colorectal Dis. 2009 Oct;24(10):1187-92. doi: 10.1007/s00384-009-0730-2. Epub 2009 May 6.
PMID: 19418060
citation: Parashar UD, Holman RC, Cummings KC, Staggs NW, Curns AT, Zimmerman CM, Kaufman SF, Lewis JE, Vugia DJ, Powell KE, Glass RI. Trends in intussusception-associated hospitalizations and deaths among US infants. Pediatrics. 2000 Dec;106(6):1413-21. doi: 10.1542/peds.106.6.1413.
PMID: 11099597
responsible party type: Principal Investigator
investigator affiliation: Minia University
investigator full name: Alaa A.E. Moustafa, MD
investigator title: Principal Investigator
mesh term: Intussusception