<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/NCT03256669</url>
  </required_header>
  <id_info>
    <org_study_id>1a765</org_study_id>
    <nct_id>NCT03256669</nct_id>
  </id_info>
  <brief_title>Umblical Incision for Neonatal Surgery</brief_title>
  <official_title>Umblical Incision for Neonatal Surgey; is it Suitable</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>
      Abdominal exploration leave an ugly scar that live with the baby forever, laparoscopy can&#xD;
      solve the problem to some extent by making a smaller scar but takes more time and need&#xD;
      special surgical skills. Umbilical incision can combine the advantage of open and laparoscopy&#xD;
      and avoid the drawbacks of both.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      six cases were subjected to the study 2 cases have duodenal atresia, one case has annular&#xD;
      pancreas, one case has jujenal atresia chritmas tree, one case has jujenal web and a case of&#xD;
      malrotation. all of them had made exploration by the umbilical incision, and no drains had&#xD;
      been used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>operative time</measure>
    <time_frame>2 hours</time_frame>
    <description>how long the peration does take</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cosmotic appearance</measure>
    <time_frame>2 weeks</time_frame>
    <description>shape of the wound</description>
  </secondary_outcome>
  <other_outcome>
    <measure>result</measure>
    <time_frame>1 week</time_frame>
    <description>surgical result successful or not</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Neonatal Surgery</condition>
  <arm_group>
    <arm_group_label>umbilical incision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>neonates undergone surgery by umbilical incision</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>umbilical incision</intervention_name>
    <description>exploration through umbilical incision</description>
    <arm_group_label>umbilical incision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  neonate diagnosed radiologically&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unclear diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Hours</minimum_age>
    <maximum_age>20 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Asyut</city>
        <zip>71526</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Gamal Abdelmalek</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <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/NCT03256669
org study id: 1a765
nct id: NCT03256669
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Abdominal exploration leave an ugly scar that live with the baby forever, laparoscopy can
      solve the problem to some extent by making a smaller scar but takes more time and need
      special surgical skills. Umbilical incision can combine the advantage of open and laparoscopy
      and avoid the drawbacks of both.
six cases were subjected to the study 2 cases have duodenal atresia, one case has annular
      pancreas, one case has jujenal atresia chritmas tree, one case has jujenal web and a case of
      malrotation. all of them had made exploration by the umbilical incision, and no drains had
      been used.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: operative time
time frame: 2 hours
description: how long the peration does take
measure: cosmotic appearance
time frame: 2 weeks
description: shape of the wound
measure: result
time frame: 1 week
description: surgical result successful or not
arm group label: umbilical incision
arm group type: Experimental
description: neonates undergone surgery by umbilical incision
intervention type: Procedure
intervention name: umbilical incision
description: exploration through umbilical incision
arm group label: umbilical incision
criteria: 
gender: All
minimum age: 20 Hours
maximum age: 20 Days
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Gamal Abdelmalek
investigator title: assistant lecturer
sharing ipd: No