<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/NCT04442139</url>
  </required_header>
  <id_info>
    <org_study_id>TaBLFood-MGB</org_study_id>
    <nct_id>NCT04442139</nct_id>
  </id_info>
  <brief_title>Patient Reported Outcomes of a &quot;Tailored&quot; Bilio-Pancreatic Limb Length on Daily Food Choices in Mini-Gastric Bypass</brief_title>
  <acronym>TaBLFood-MGB</acronym>
  <official_title>Patient Reported Outcomes of a &quot;Tailored&quot; Bilio-Pancreatic Limb Length on Mean Weight Loss and Mean Daily Dietary Food Choices in the One Anastomosis Gastric Bypass (Mini-Gastric Bypass-Original Technique)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kular Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kular Hospital</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>
      Bariatric surgery (BS) has a history of new procedures and techniques arising and then&#xD;
      disappearing due to problems and complications. The present is no different with new and old&#xD;
      procedures changing with the regularity of night following day.&#xD;
&#xD;
      One of the important questions today in BS is the length and or need/value of the&#xD;
      Biliopancreatic limb bypass (BPLL.) The Sleeve and the Band have &quot;0&quot; bypass, the RNY has a&#xD;
      &quot;short&quot; bypass and the Biliopancreatic Diversion type procedures have a &quot;long&quot; (distal)&#xD;
      bypass.&#xD;
&#xD;
      The Mini-Gastric Bypass Original Technique (MGB-OT) version of the One Anastomosis Bypass&#xD;
      (OAGB) includes a &quot;medium&quot; length of bypass, longer than the BPLL of the RNY and shorter than&#xD;
      the the &quot;Long&quot; BPL of the BPD procedures. In addition, uniquely, the MGB-OT includes a&#xD;
      &quot;Tailored&quot; BPLL.&#xD;
&#xD;
      Not all OAGB surgeons use this approach and several have argued in favor of a &quot;Fixed&quot; BPLL of&#xD;
      150 cm.&#xD;
&#xD;
      This paper is part of a series of studies of the &quot;Tailored&quot; BPLL specifically in MGB-OT&#xD;
      patients.&#xD;
&#xD;
      Notably it demonstrates in an online survey that patient reported weight loss and food&#xD;
      choices change after MGB-OT and in addition the changes are related to the &quot;Tailored&quot; BPLL&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Studies of different Bariatric procedures have resulted in conflicting findings on the&#xD;
      effects of the surgery on daily Dietary Food Choices (DFCs.) Some suggest a pure volume&#xD;
      effect, others report changes in type and preferences and still others suggest the effects&#xD;
      change over time. The Biliopancreatic Limb Length (BPLL) in the One Anastomosis Gastric&#xD;
      Bypass (OAGB), Mini-Gastric Bypass-Original Technique (MGB-OT) version, includes a &quot;tailored&quot;&#xD;
      BPLL. The purpose of this study was to investigate the relationship between BPLL and DFCs in&#xD;
      patients undergoing MGB-OT. The primary hypothesis was that the changes in dietary habits and&#xD;
      food choices would be related to the BPLL in the MGB-OT.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Data from a long term online patient survey including MGB-OT patients were collected&#xD;
      including basic demographics, MGB-OT BPLL, patient reported DFCs and weight loss classes.&#xD;
      Linear regression modeling was used to assess the relative association between BPLL with&#xD;
      various mean patient reported DFCs and a composite model of Food Choices.&#xD;
&#xD;
      Results:&#xD;
&#xD;
      Patients survey responses to be evaluated. Patients with reported BPLLs of 3 to 9 ft&#xD;
      (92-274cm) will be selected. Patient reported mean weight loss classes to be evaluated. The&#xD;
      linear relation to BPLL to be evaluated. The mean &quot;Bad&quot; Food Choices (BFC) to be determined.&#xD;
&#xD;
      Conclusions:&#xD;
&#xD;
      The present study of mean patient reported DFC outcomes following a &quot;Tailored&quot; BPLL in the&#xD;
      MGB-OT version of the OAGB to be evaluated. The patient dietary food choices for fried foods,&#xD;
      sugar sweetened beverages, processed meats and junk foods all to be determined. These changes&#xD;
      linear regression to the Bilio-pancreatic limb length to be determined. In cases of the&#xD;
      MGB-OT a longer Bilio-pancreatic Limb Length association with greater weight loss and a&#xD;
      greater improvement in daily Dietary Food Choices would be major importance. The possibility&#xD;
      of tailoring the power of a bariatric operation based upon BPLL might well be an important&#xD;
      advancement in bariatric surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2008</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Food Choices</measure>
    <time_frame>from 1 year up to 10 years post operative Mini-Gastric Bypass</time_frame>
    <description>Patient Reported Food choices</description>
  </primary_outcome>
  <other_outcome>
    <measure>Weight Loss</measure>
    <time_frame>from 1 year up to 10 years post operative Mini-Gastric Bypass</time_frame>
    <description>Pre and post reported weights and amount of reported weight loss</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">190</enrollment>
  <condition>Obesity</condition>
  <condition>Morbid Obesity</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Food Selection</condition>
  <condition>Diet Habit</condition>
  <arm_group>
    <arm_group_label>Mini-Gastric Bypass</arm_group_label>
    <description>Patients reported completing survey following Mini-Gastric Bypass</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mini-Gastric Bypass</intervention_name>
    <description>Mini-Gastric Bypass bariatric surgery</description>
    <arm_group_label>Mini-Gastric Bypass</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients completing survey following surgery for Mini-Gastric Bypass performed for morbid&#xD;
        obesity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Post Mini-Gastric Bypass Patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>R Rutledge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kular Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kular Hospital</name>
      <address>
        <city>Khanna</city>
        <state>Punjab</state>
        <zip>141412</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kular Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Robert Rutledge</investigator_full_name>
    <investigator_title>Research Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <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/NCT04442139
org study id: TaBLFood-MGB
nct id: NCT04442139
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bariatric surgery (BS) has a history of new procedures and techniques arising and then
      disappearing due to problems and complications. The present is no different with new and old
      procedures changing with the regularity of night following day.

      One of the important questions today in BS is the length and or need/value of the
      Biliopancreatic limb bypass (BPLL.) The Sleeve and the Band have "0" bypass, the RNY has a
      "short" bypass and the Biliopancreatic Diversion type procedures have a "long" (distal)
      bypass.

      The Mini-Gastric Bypass Original Technique (MGB-OT) version of the One Anastomosis Bypass
      (OAGB) includes a "medium" length of bypass, longer than the BPLL of the RNY and shorter than
      the the "Long" BPL of the BPD procedures. In addition, uniquely, the MGB-OT includes a
      "Tailored" BPLL.

      Not all OAGB surgeons use this approach and several have argued in favor of a "Fixed" BPLL of
      150 cm.

      This paper is part of a series of studies of the "Tailored" BPLL specifically in MGB-OT
      patients.

      Notably it demonstrates in an online survey that patient reported weight loss and food
      choices change after MGB-OT and in addition the changes are related to the "Tailored" BPLL
Introduction:

      Studies of different Bariatric procedures have resulted in conflicting findings on the
      effects of the surgery on daily Dietary Food Choices (DFCs.) Some suggest a pure volume
      effect, others report changes in type and preferences and still others suggest the effects
      change over time. The Biliopancreatic Limb Length (BPLL) in the One Anastomosis Gastric
      Bypass (OAGB), Mini-Gastric Bypass-Original Technique (MGB-OT) version, includes a "tailored"
      BPLL. The purpose of this study was to investigate the relationship between BPLL and DFCs in
      patients undergoing MGB-OT. The primary hypothesis was that the changes in dietary habits and
      food choices would be related to the BPLL in the MGB-OT.

      Methods:

      Data from a long term online patient survey including MGB-OT patients were collected
      including basic demographics, MGB-OT BPLL, patient reported DFCs and weight loss classes.
      Linear regression modeling was used to assess the relative association between BPLL with
      various mean patient reported DFCs and a composite model of Food Choices.

      Results:

      Patients survey responses to be evaluated. Patients with reported BPLLs of 3 to 9 ft
      (92-274cm) will be selected. Patient reported mean weight loss classes to be evaluated. The
      linear relation to BPLL to be evaluated. The mean "Bad" Food Choices (BFC) to be determined.

      Conclusions:

      The present study of mean patient reported DFC outcomes following a "Tailored" BPLL in the
      MGB-OT version of the OAGB to be evaluated. The patient dietary food choices for fried foods,
      sugar sweetened beverages, processed meats and junk foods all to be determined. These changes
      linear regression to the Bilio-pancreatic limb length to be determined. In cases of the
      MGB-OT a longer Bilio-pancreatic Limb Length association with greater weight loss and a
      greater improvement in daily Dietary Food Choices would be major importance. The possibility
      of tailoring the power of a bariatric operation based upon BPLL might well be an important
      advancement in bariatric surgery.
observational model: Cohort
time perspective: Retrospective
measure: Food Choices
time frame: from 1 year up to 10 years post operative Mini-Gastric Bypass
description: Patient Reported Food choices
measure: Weight Loss
time frame: from 1 year up to 10 years post operative Mini-Gastric Bypass
description: Pre and post reported weights and amount of reported weight loss
arm group label: Mini-Gastric Bypass
description: Patients reported completing survey following Mini-Gastric Bypass
intervention type: Other
intervention name: Mini-Gastric Bypass
description: Mini-Gastric Bypass bariatric surgery
arm group label: Mini-Gastric Bypass
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: R Rutledge, MD
role: Principal Investigator
affiliation: Kular Hospital
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Kular Hospital
investigator full name: Dr. Robert Rutledge
investigator title: Research Director
mesh term: Obesity
mesh term: Obesity, Morbid
sharing ipd: No