<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/NCT03838276</url>
  </required_header>
  <id_info>
    <org_study_id>HRJC 19-21</org_study_id>
    <nct_id>NCT03838276</nct_id>
  </id_info>
  <brief_title>RYGB AL 150cm BPL 100cm vs RYGB AL 100cc BPL 150cm</brief_title>
  <official_title>Ponderal Outcomes After Roux-en-Y Gastric Bypass With Alimentary Limb (AL) of 150cm and Biliopancreatic Limb (BPL) of 100cm vs AL 100cm and BPL 150cm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Elche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Elche</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>
      A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized&#xD;
      according the limb lengths:&#xD;
&#xD;
        -  Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm&#xD;
&#xD;
        -  Group 2: AL 100cm and BPL 150cm&#xD;
&#xD;
      Weight loss will be evaluated 1 year after surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized&#xD;
      according the limb lengths:&#xD;
&#xD;
        -  Group 1: Alimentary limb 150cm and biliopancreatic limb 100cm&#xD;
&#xD;
        -  Group 2: Alimentary limb 100cm and biliopancreatic limb 150cm&#xD;
&#xD;
      Weight loss will be evaluated 1 year after surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">February 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 15, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Weight loss will be assessed 1 year after surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>AL150 BPL100</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AL100 BPL150</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>AL 150 BPL100</intervention_name>
    <description>Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb</description>
    <arm_group_label>AL150 BPL100</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>AL 100 BPL 150</intervention_name>
    <description>Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb</description>
    <arm_group_label>AL100 BPL150</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 40 Kg/m2&#xD;
&#xD;
          -  BMI &gt; 35 Kg/m2, associated with obesity-related comorbidities&#xD;
&#xD;
          -  Patients undergoing Roux-en-Y gastric bypass as bariatric procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing Roux-en-Y gastric bypass as revisional procedure&#xD;
&#xD;
          -  Patients lost to follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Santiago de Battista</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital La PLata</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jaime Ruiz-Tovar</last_name>
    <phone>630534808</phone>
    <email>jruiztovar@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lucas Rivalletto</last_name>
    <phone>+34654987159</phone>
  </overall_contact_backup>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 9, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 9, 2019</last_update_submitted>
  <last_update_submitted_qc>February 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Elche</investigator_affiliation>
    <investigator_full_name>Jaime Ruiz-Tovar, MD, PhD</investigator_full_name>
    <investigator_title>Department of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</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/NCT03838276
org study id: HRJC 19-21
nct id: NCT03838276
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized
      according the limb lengths:

        -  Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm

        -  Group 2: AL 100cm and BPL 150cm

      Weight loss will be evaluated 1 year after surgery
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized
      according the limb lengths:

        -  Group 1: Alimentary limb 150cm and biliopancreatic limb 100cm

        -  Group 2: Alimentary limb 100cm and biliopancreatic limb 150cm

      Weight loss will be evaluated 1 year after surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight loss
time frame: 1 year after surgery
description: Weight loss will be assessed 1 year after surgery
arm group label: AL150 BPL100
arm group type: Active Comparator
description: Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb
arm group label: AL100 BPL150
arm group type: Experimental
description: Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb
intervention type: Procedure
intervention name: AL 150 BPL100
description: Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb
arm group label: AL150 BPL100
intervention type: Procedure
intervention name: AL 100 BPL 150
description: Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb
arm group label: AL100 BPL150
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Santiago de Battista
role: Study Chair
affiliation: Hospital La PLata
last name: Jaime Ruiz-Tovar
phone: 630534808
email: jruiztovar@gmail.com
last name: Lucas Rivalletto
phone: +34654987159
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Elche
investigator full name: Jaime Ruiz-Tovar, MD, PhD
investigator title: Department of Surgery
mesh term: Weight Loss