<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/NCT04504656</url>
  </required_header>
  <id_info>
    <org_study_id>Esophageal replacement</org_study_id>
    <nct_id>NCT04504656</nct_id>
  </id_info>
  <brief_title>Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children</brief_title>
  <official_title>Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children</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>
      a comparative prospective study of postoperative between minimally invasive and open surgery&#xD;
      complications for esophageal replacement in children&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Esophageal replacement in childhood is indicated in esophageal atresia patients with long-gap&#xD;
      defects or following complications of primary esophageal anastomosis, as well as in patients&#xD;
      with trauma and scarring to the esophagus following caustic ingestion. It is widely accepted&#xD;
      that the ideal esophageal replacement is one that resembles the function of the native&#xD;
      esophagus with minimal deterioration over time. Several techniques of esophageal replacement&#xD;
      have been developed. These have focused mainly on the use of native tissues (including the&#xD;
      stomach, jejunum, and colon) as conduits (1), attempts to use a synthetic prosthesis have&#xD;
      been largely unsuccessful. In an attempt to reduce the trauma and morbidity associated with&#xD;
      laparotomy and thoracotomy incisions, minimally invasive techniques are increasingly used.&#xD;
      (2-4). Meta-analyses of adult esophagectomy for the treatment of esophageal cancer support&#xD;
      the use of minimally invasive surgery (5) however, equivalent comparative studies in the&#xD;
      pediatric population are lacking. As such, it is unclear whether minimally esophageal&#xD;
      replacement is as safe as the open procedure in children. The present study aims to address&#xD;
      this question by comparing the postoperative outcomes of children who underwent minimally&#xD;
      invasive versus open esophageal replacement procedures at single-center and multicenter&#xD;
      levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2022</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>Anastamotic leaks</measure>
    <time_frame>2 years</time_frame>
    <description>Incidence of anastamotic leak which is identified clinically in both groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anastamotic stricture</measure>
    <time_frame>2 years</time_frame>
    <description>Incidence of symptomstic strictures which is identified by upper barium studies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>2 years</time_frame>
    <description>Number of patient who die intraoperative and post operative in both groups</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Post-Op Complication</condition>
  <condition>Anastomosis; Complications</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>open surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>minimally invasive surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observation of postoperative leak, stenosis, mortality</intervention_name>
    <description>detect complications in both groups</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        children up to 18 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All children undergoing oesophageal replacement aged one to 18 years. Due to&#xD;
&#xD;
          1. long gap esophageal atresia&#xD;
&#xD;
          2. caustic ingestion&#xD;
&#xD;
          3. congenital esophageal stenosis or strictures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient who underwent previous esophageal replacement operations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Eltayeb, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Maher, Msc.</last_name>
    <phone>01026338229</phone>
    <email>ahmedmaherali31@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mahmoud Mohamed Mostafa, MD</last_name>
    <phone>01005010897</phone>
    <email>mmostafa@aun.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University Children Hospitals</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Abdel-Kadir Othman Ahmed, MD</last_name>
      <phone>01062226639</phone>
      <email>osman@med.aun.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>A maher</investigator_full_name>
    <investigator_title>Assistant lecturer of surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </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/NCT04504656
org study id: Esophageal replacement
nct id: NCT04504656
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
a comparative prospective study of postoperative between minimally invasive and open surgery
      complications for esophageal replacement in children
Esophageal replacement in childhood is indicated in esophageal atresia patients with long-gap
      defects or following complications of primary esophageal anastomosis, as well as in patients
      with trauma and scarring to the esophagus following caustic ingestion. It is widely accepted
      that the ideal esophageal replacement is one that resembles the function of the native
      esophagus with minimal deterioration over time. Several techniques of esophageal replacement
      have been developed. These have focused mainly on the use of native tissues (including the
      stomach, jejunum, and colon) as conduits (1), attempts to use a synthetic prosthesis have
      been largely unsuccessful. In an attempt to reduce the trauma and morbidity associated with
      laparotomy and thoracotomy incisions, minimally invasive techniques are increasingly used.
      (2-4). Meta-analyses of adult esophagectomy for the treatment of esophageal cancer support
      the use of minimally invasive surgery (5) however, equivalent comparative studies in the
      pediatric population are lacking. As such, it is unclear whether minimally esophageal
      replacement is as safe as the open procedure in children. The present study aims to address
      this question by comparing the postoperative outcomes of children who underwent minimally
      invasive versus open esophageal replacement procedures at single-center and multicenter
      levels.
observational model: Cohort
time perspective: Prospective
measure: Anastamotic leaks
time frame: 2 years
description: Incidence of anastamotic leak which is identified clinically in both groups
measure: Anastamotic stricture
time frame: 2 years
description: Incidence of symptomstic strictures which is identified by upper barium studies
measure: Mortality
time frame: 2 years
description: Number of patient who die intraoperative and post operative in both groups
arm group label: 1
description: open surgery
arm group label: 2
description: minimally invasive surgery
intervention type: Other
intervention name: observation of postoperative leak, stenosis, mortality
description: detect complications in both groups
arm group label: 1
arm group label: 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Ahmed Eltayeb, MD
role: Study Director
affiliation: Assiut University
last name: Ahmed Maher, Msc.
phone: 01026338229
email: ahmedmaherali31@gmail.com
last name: Mahmoud Mohamed Mostafa, MD
phone: 01005010897
email: mmostafa@aun.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: A maher
investigator title: Assistant lecturer of surgery
mesh term: Postoperative Complications
sharing ipd: Yes
ipd info type: Study Protocol