<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/NCT04440306</url>
  </required_header>
  <id_info>
    <org_study_id>BPLL-vs-WtLoss</org_study_id>
    <nct_id>NCT04440306</nct_id>
  </id_info>
  <brief_title>&quot;Tailored&quot; Bilio-Pancreatic Limb Length and Weight Loss After Mini-Gastric Bypass</brief_title>
  <acronym>BplVsWtLoss</acronym>
  <official_title>&quot;Tailored&quot; Bilio-Pancreatic Limb Length and Weight Loss After One Anastomosis Gastric Bypass [&quot; Mini-Gastric Bypass Original Technique&quot;]</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>
      Retrospective review of prospectively collected blinded patient data. To Address simple&#xD;
      question:&#xD;
&#xD;
      In cases of Mini-Gastric Bypass performed using the Original Technique what (if any) is the&#xD;
      relation between the Bilio-pancreatic limb length (BPLL) and the patient weight loss at 10&#xD;
      years following operation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods:&#xD;
&#xD;
      The investigators performed a review of a prospectively collected database system of patients&#xD;
      undergoing tailored MGB-OT at Kular hospital, Punjab, India. Patients who underwent tailored&#xD;
      MGB-OT between June 2008 and December 2009 were included. Primary outcomes of interest&#xD;
      included a variety of weight loss outcome measures including % Excess Weight Loss (%EWL) at&#xD;
      1, 5 and 10 years in relation to a &quot;tailored&quot; Bilio-Pancreatic Limb Length (BPLL.)&#xD;
&#xD;
      The study was motivated by questions raised suggesting that a BPLL in the OAGB (MGB-OT)&#xD;
      should be limited to 150 cm. Data were collected with a team of nurses and support staff that&#xD;
      maintained a daily calling and follow up list adding data to an easily accessible online&#xD;
      electronic database.&#xD;
&#xD;
      The analytic process assessed various weight loss outcomes at 1, 5 and 10 years following&#xD;
      &quot;tailored&quot; BPLLs in patients undergoing the Mini-Gastric Bypass Original Technique (MGB-OT)&#xD;
      as described by Rutledge. In addition to using simple statistical methods to assess the&#xD;
      relation of the BPLLs to weight loss outcomes, a linear regression model was used to analyse&#xD;
      and quantify the relationship between the length of the tailored BP limb and the weight loss&#xD;
      measures a 1, 5 and 10 years after operation.&#xD;
&#xD;
      The study design focused upon the &quot;power&quot; of the BPLL as measured by 1, 5 and 10 year weight&#xD;
      loss outcomes. The study was designed to answer two specific questions: first is a &quot;FIXED&quot;&#xD;
      BPLL of 150 cm best for everyone (I.e. like the fixed BPLL used in the RNY) or put&#xD;
      differently: is a 150 cm BPLL equally efficacious as compared to a longer BPLL when judged by&#xD;
      measures of weight loss at 1, 5 and 10 years after surgery. Analysis included comparing BPLLs&#xD;
      to the various 1, 5 and 10 year weight loss measures such as BMI, %BMI lost, Total weight at&#xD;
      10 years, % Excess Weight Loss at 10 yrs and other standard outcome measures.&#xD;
&#xD;
      Further, if such a relationship does indeed exist, can it be more precisely quantified? For&#xD;
      example, is it &quot;linear,&quot; that is to say for each and every additional cm of BPLL do the&#xD;
      various long term weight loss measures increase similarly?.&#xD;
&#xD;
      There are of course many other questions now in bariatric surgery and related to the MGB/OAGB&#xD;
      but the present study was designed to be sharply focused upon these two questions. Risk&#xD;
      benefit and predictive power and multivariate analysis and creation of guidelines are in&#xD;
      process and have been addressed in the past and will be part of subsequent publications., , ,&#xD;
&#xD;
      Notably the government of India health-care system provides no support for bariatric surgery&#xD;
      and specifically no support at all for the MGB at any time during the course of this study&#xD;
      and up until the time of this writing. All patients in the study paid out of pocket for the&#xD;
      operation. The self pay situation and the fact that poor outcomes are little tolerated are&#xD;
      also worthwhile noting. Given this climate and the capped hospital resources in a small town,&#xD;
      it has been remarkable that the surgeons in this study have maintained a sterling record of&#xD;
      excellent outcomes, a busy clinical practice with outcomes and results that rival those&#xD;
      reported from other areas of the world including some of the best hospitals in the United&#xD;
      States. The &quot;tailored&quot; MGB-OT used by the surgeon authors facilitated excellent outcomes and&#xD;
      supported their success even in such demanding circumstances.&#xD;
&#xD;
      Once a significant association between BPLL and outcomes was determined, then a linear&#xD;
      regression analysis was performed to further quantitate and describe the relationship between&#xD;
      BPLL and outcome measures.&#xD;
&#xD;
      The present small first step is part of a longer term effort to investigate creation of a&#xD;
      tool so robust that it might act as a guide for both patients and surgeons who might select&#xD;
      the MGB-OT.&#xD;
&#xD;
      The study was conducted in accordance with the principles of the Declaration of Helsinki.&#xD;
      Ethical permission was obtained from the local ethics committee and all participants provided&#xD;
      written informed consent for data sharing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>Percent Excess Weight Loss</measure>
    <time_frame>10 years following operation</time_frame>
    <description>Amount of weight lost assessed by Percent Excess Weight Loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Total Weight Loss</measure>
    <time_frame>10 years following operation</time_frame>
    <description>Amount of weight lost assessed by Percent of Total Weight Loss</description>
  </primary_outcome>
  <enrollment type="Actual">191</enrollment>
  <condition>Obesity, Morbid</condition>
  <condition>Weight Loss</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Power</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mini-Gastric Bypass - Original Technique</intervention_name>
    <description>Mini-Gastric Bypass - Original Technique is widely used form of bariatric surgery and includes a tailored BPLL</description>
    <other_name>Tailored Bilio-Pancreatic Limb Length</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients selected for Mini-Gastric Bypass - Original Technique at Kular Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Patients selected for Mini-Gastric Bypass - Original Technique at Kular&#xD;
        Hospital -&#xD;
&#xD;
        Exclusion Criteria: None&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </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 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 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>
  <keyword>Mini-Gastric Bypass</keyword>
  <keyword>Bilio-Pancreatic Limb Length</keyword>
  <keyword>Weight loss</keyword>
  <keyword>One Anastomosis Gastric Bypass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</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/NCT04440306
org study id: BPLL-vs-WtLoss
nct id: NCT04440306
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective review of prospectively collected blinded patient data. To Address simple
      question:

      In cases of Mini-Gastric Bypass performed using the Original Technique what (if any) is the
      relation between the Bilio-pancreatic limb length (BPLL) and the patient weight loss at 10
      years following operation.
Methods:

      The investigators performed a review of a prospectively collected database system of patients
      undergoing tailored MGB-OT at Kular hospital, Punjab, India. Patients who underwent tailored
      MGB-OT between June 2008 and December 2009 were included. Primary outcomes of interest
      included a variety of weight loss outcome measures including % Excess Weight Loss (%EWL) at
      1, 5 and 10 years in relation to a "tailored" Bilio-Pancreatic Limb Length (BPLL.)

      The study was motivated by questions raised suggesting that a BPLL in the OAGB (MGB-OT)
      should be limited to 150 cm. Data were collected with a team of nurses and support staff that
      maintained a daily calling and follow up list adding data to an easily accessible online
      electronic database.

      The analytic process assessed various weight loss outcomes at 1, 5 and 10 years following
      "tailored" BPLLs in patients undergoing the Mini-Gastric Bypass Original Technique (MGB-OT)
      as described by Rutledge. In addition to using simple statistical methods to assess the
      relation of the BPLLs to weight loss outcomes, a linear regression model was used to analyse
      and quantify the relationship between the length of the tailored BP limb and the weight loss
      measures a 1, 5 and 10 years after operation.

      The study design focused upon the "power" of the BPLL as measured by 1, 5 and 10 year weight
      loss outcomes. The study was designed to answer two specific questions: first is a "FIXED"
      BPLL of 150 cm best for everyone (I.e. like the fixed BPLL used in the RNY) or put
      differently: is a 150 cm BPLL equally efficacious as compared to a longer BPLL when judged by
      measures of weight loss at 1, 5 and 10 years after surgery. Analysis included comparing BPLLs
      to the various 1, 5 and 10 year weight loss measures such as BMI, %BMI lost, Total weight at
      10 years, % Excess Weight Loss at 10 yrs and other standard outcome measures.

      Further, if such a relationship does indeed exist, can it be more precisely quantified? For
      example, is it "linear," that is to say for each and every additional cm of BPLL do the
      various long term weight loss measures increase similarly?.

      There are of course many other questions now in bariatric surgery and related to the MGB/OAGB
      but the present study was designed to be sharply focused upon these two questions. Risk
      benefit and predictive power and multivariate analysis and creation of guidelines are in
      process and have been addressed in the past and will be part of subsequent publications., , ,

      Notably the government of India health-care system provides no support for bariatric surgery
      and specifically no support at all for the MGB at any time during the course of this study
      and up until the time of this writing. All patients in the study paid out of pocket for the
      operation. The self pay situation and the fact that poor outcomes are little tolerated are
      also worthwhile noting. Given this climate and the capped hospital resources in a small town,
      it has been remarkable that the surgeons in this study have maintained a sterling record of
      excellent outcomes, a busy clinical practice with outcomes and results that rival those
      reported from other areas of the world including some of the best hospitals in the United
      States. The "tailored" MGB-OT used by the surgeon authors facilitated excellent outcomes and
      supported their success even in such demanding circumstances.

      Once a significant association between BPLL and outcomes was determined, then a linear
      regression analysis was performed to further quantitate and describe the relationship between
      BPLL and outcome measures.

      The present small first step is part of a longer term effort to investigate creation of a
      tool so robust that it might act as a guide for both patients and surgeons who might select
      the MGB-OT.

      The study was conducted in accordance with the principles of the Declaration of Helsinki.
      Ethical permission was obtained from the local ethics committee and all participants provided
      written informed consent for data sharing.
observational model: Cohort
time perspective: Retrospective
measure: Percent Excess Weight Loss
time frame: 10 years following operation
description: Amount of weight lost assessed by Percent Excess Weight Loss
measure: Percent Total Weight Loss
time frame: 10 years following operation
description: Amount of weight lost assessed by Percent of Total Weight Loss
intervention type: Procedure
intervention name: Mini-Gastric Bypass - Original Technique
description: Mini-Gastric Bypass - Original Technique is widely used form of bariatric surgery and includes a tailored BPLL
other name: Tailored Bilio-Pancreatic Limb Length
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
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, Morbid
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: No