xml: <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/NCT05979233</url>
    </required_header>
    <id_info>
      <org_study_id>fac.med.23.42</org_study_id>
      <nct_id>NCT05979233</nct_id>
    </id_info>
    <brief_title>One Session Vs Staged Management of Calcular Obstructive Jaundice</brief_title>
    <official_title>One Session Vs Staged Laropendoscopic Management of Calcular Obstructive Jaundice</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>
        to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs&#xD;
        staged management&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic&#xD;
        cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy&#xD;
        then ERCP in the same session in group 3 we will do staged management&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 5, 2023</start_date>
    <completion_date type="Anticipated">February 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>total cost</measure>
      <time_frame>6 months</time_frame>
      <description>total cost in Egyptian pound</description>
    </primary_outcome>
    <primary_outcome>
      <measure>hospital stay</measure>
      <time_frame>6 months</time_frame>
      <description>total hospital stay in days</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>complications</measure>
      <time_frame>30 days</time_frame>
      <description>early postoperative complications</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Calcular Obstructive Jaundice</condition>
    <condition>Gall Bladder Disease</condition>
    <arm_group>
      <arm_group_label>staged managment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>ERCP then interval laparoscopic cholecystectomy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>one session ERCP then LC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>one session ERCP then LC</description>
    </arm_group>
    <arm_group>
      <arm_group_label>one session LC then ERCP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>one session LC then ERCP</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>staged managment</intervention_name>
      <description>staged management</description>
      <arm_group_label>staged managment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>one session ERCP then LC</intervention_name>
      <description>one session ERCP then LC</description>
      <arm_group_label>one session ERCP then LC</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>one session LC then ERCP</intervention_name>
      <description>one session LC then ERCP</description>
      <arm_group_label>one session LC then ERCP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age from 18-70 year&#xD;
  &#xD;
            -  combined CBD and gall stone&#xD;
  &#xD;
            -  stone less than 1.5 cm&#xD;
  &#xD;
            -  fit for surgery&#xD;
  &#xD;
            -  no upper abdominal surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age &lt;18 and &gt;70&#xD;
  &#xD;
            -  unfit for surgery&#xD;
  &#xD;
            -  stone more than 1.5 cm&#xD;
  &#xD;
            -  upper abdominal surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of medicine</name>
        <address>
          <city>Minya</city>
          <zip>61511</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Minia University</investigator_affiliation>
      <investigator_full_name>Alaa Mstafa Hassan Sewefy</investigator_full_name>
      <investigator_title>MD, professor &amp; consultant of general surgery, Department of surgery, Minia university hospital, Egypt</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gallbladder Diseases</mesh_term>
      <mesh_term>Urinary Bladder Diseases</mesh_term>
      <mesh_term>Jaundice</mesh_term>
      <mesh_term>Jaundice, Obstructive</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979233
  org study id: fac.med.23.42
  nct id: NCT05979233
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs
        staged management
  to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic
        cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy
        then ERCP in the same session in group 3 we will do staged management
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: total cost
  time frame: 6 months
  description: total cost in Egyptian pound
  measure: hospital stay
  time frame: 6 months
  description: total hospital stay in days
  measure: complications
  time frame: 30 days
  description: early postoperative complications
  arm group label: staged managment
  arm group type: Active Comparator
  description: ERCP then interval laparoscopic cholecystectomy
  arm group label: one session ERCP then LC
  arm group type: Experimental
  description: one session ERCP then LC
  arm group label: one session LC then ERCP
  arm group type: Experimental
  description: one session LC then ERCP
  intervention type: Procedure
  intervention name: staged managment
  description: staged management
  arm group label: staged managment
  intervention type: Procedure
  intervention name: one session ERCP then LC
  description: one session ERCP then LC
  arm group label: one session ERCP then LC
  intervention type: Procedure
  intervention name: one session LC then ERCP
  description: one session LC then ERCP
  arm group label: one session LC then ERCP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Minia University
  investigator full name: Alaa Mstafa Hassan Sewefy
  investigator title: MD, professor & consultant of general surgery, Department of surgery, Minia university hospital, Egypt
  mesh term: Gallbladder Diseases
  mesh term: Urinary Bladder Diseases
  mesh term: Jaundice
  mesh term: Jaundice, Obstructive