<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/NCT01686997</url>
  </required_header>
  <id_info>
    <org_study_id>Elegance01</org_study_id>
    <nct_id>NCT01686997</nct_id>
  </id_info>
  <brief_title>Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities</brief_title>
  <acronym>Elegance</acronym>
  <official_title>'Effect of Long biLiopancrEatic Limb lenGth in lAparoscopic Roux-eN-Y Gastric Bypass on Weight Loss and Comorbidities in Patients With Morbid obEsity: a Prospective Randomized Control Trial'</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rijnstate Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rijnstate Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Morbid obesity is an increasing medical problem in the western countries. It's related to&#xD;
      comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia.&#xD;
      The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese&#xD;
      patients. A part of these patients will have disappointing results, and have weight regain on&#xD;
      the long term. Some studies show more weight reduction by increasing the biliopancreatic limb&#xD;
      in patients with morbid obesity.&#xD;
&#xD;
      The objective of this study is to investigate the effect of variations in the length of&#xD;
      biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery.&#xD;
      We hypothesize that longer biliopancreatic limb results in more weight reduction.&#xD;
&#xD;
      The study design is a prospective, randomized control trial. The patients will be randomized&#xD;
      in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight reduction</measure>
    <time_frame>2 years</time_frame>
    <description>excess weight loss (%EWL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in comorbidities</measure>
    <time_frame>2 years</time_frame>
    <description>diabetes mellitus, hypertension, hypercholesterolemia, arthrosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>SF-36 and BAROS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications and re-operations</measure>
    <time_frame>2 years</time_frame>
    <description>bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>Primairy long biliopancreatic limb RYGB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Roux limb 75 cm and Biliopancreatic Limb 150 cm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Redo Long biliopancreatic limb RYGB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Roux limb 75 cm and Biliopancreatic limb 150 cm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primairy standard RYGB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Roux limb 150 cm and Biliopancreatic limb 75 cm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Redo standard RYGB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Roux limb 150 cm and Biliopancreatic limb 75 cm</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Roux-en-Y Gastric Bypass</intervention_name>
    <arm_group_label>Primairy long biliopancreatic limb RYGB</arm_group_label>
    <arm_group_label>Primairy standard RYGB</arm_group_label>
    <arm_group_label>Redo Long biliopancreatic limb RYGB</arm_group_label>
    <arm_group_label>Redo standard RYGB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient eligible for bariatric surgery according Fried guidelines&#xD;
&#xD;
        Primary Gastric bypass&#xD;
&#xD;
          -  BMI 35 - 40 with a comorbidity&#xD;
&#xD;
          -  or BMI &gt; 40&#xD;
&#xD;
        Redo- operation&#xD;
&#xD;
          -  medical history: gastric sleeve/ mason / gastric band&#xD;
&#xD;
          -  all BMI levels&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria for bariatric surgery (Fried Guidelines)&#xD;
&#xD;
          -  Patients with language problems that interveins to follow medical advises&#xD;
&#xD;
          -  Genetic diseases that intervens to follow medical advises&#xD;
&#xD;
          -  Chronic bowel diseases&#xD;
&#xD;
          -  Nephrologic (MDRD &lt;30) of liver diseases (AST/ALT more than twice the norm)&#xD;
&#xD;
          -  Pregnancy&#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>F.J. Berends, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rijnstate Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>June 2, 2016</last_update_submitted>
  <last_update_submitted_qc>June 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bariatric surgery</keyword>
  <keyword>Roux-en-Y Gastric Bypass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
    <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/NCT01686997
org study id: Elegance01
nct id: NCT01686997
lead sponsor: 
has dmc: No
Morbid obesity is an increasing medical problem in the western countries. It's related to
      comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia.
      The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese
      patients. A part of these patients will have disappointing results, and have weight regain on
      the long term. Some studies show more weight reduction by increasing the biliopancreatic limb
      in patients with morbid obesity.

      The objective of this study is to investigate the effect of variations in the length of
      biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery.
      We hypothesize that longer biliopancreatic limb results in more weight reduction.

      The study design is a prospective, randomized control trial. The patients will be randomized
      in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Weight reduction
time frame: 2 years
description: excess weight loss (%EWL)
measure: Decrease in comorbidities
time frame: 2 years
description: diabetes mellitus, hypertension, hypercholesterolemia, arthrosis
measure: Quality of life
time frame: 2 years
description: SF-36 and BAROS
measure: Complications and re-operations
time frame: 2 years
description: bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies
arm group label: Primairy long biliopancreatic limb RYGB
arm group type: Active Comparator
description: Roux limb 75 cm and Biliopancreatic Limb 150 cm
arm group label: Redo Long biliopancreatic limb RYGB
arm group type: Active Comparator
description: Roux limb 75 cm and Biliopancreatic limb 150 cm
arm group label: Primairy standard RYGB
arm group type: Active Comparator
description: Roux limb 150 cm and Biliopancreatic limb 75 cm
arm group label: Redo standard RYGB
arm group type: Active Comparator
description: Roux limb 150 cm and Biliopancreatic limb 75 cm
intervention type: Procedure
intervention name: Roux-en-Y Gastric Bypass
arm group label: Primairy long biliopancreatic limb RYGB
arm group label: Primairy standard RYGB
arm group label: Redo Long biliopancreatic limb RYGB
arm group label: Redo standard RYGB
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: F.J. Berends, MD, PhD
role: Principal Investigator
affiliation: Rijnstate Hospital
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Obesity
mesh term: Obesity, Morbid
mesh term: Weight Loss