<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/NCT02218957</url>
  </required_header>
  <id_info>
    <org_study_id>ExtPouch</org_study_id>
    <nct_id>NCT02218957</nct_id>
  </id_info>
  <brief_title>Extended Pouch Roux-en-Y Gastric Bypass Study</brief_title>
  <official_title>Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: 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 a restrictive/extended pouch on&#xD;
      weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the&#xD;
      restrictive/extended pouch 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 (normal pouch) and restrictive/extended pouch RYGB.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">October 2017</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>Change in comorbidities</measure>
    <time_frame>2 years</time_frame>
    <description>Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:&#xD;
comorbidity resolved&#xD;
comorbidity improved&#xD;
comorbidity unchanged&#xD;
comorbidity worsened&#xD;
This will be done for diabetes mellitus, hypertension, dislipedimia and OSAS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in comorbidities</measure>
    <time_frame>2 years</time_frame>
    <description>Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:&#xD;
comorbidity resolved&#xD;
comorbidity improved&#xD;
comorbidity unchanged&#xD;
comorbidity worsened&#xD;
This will be done for diabetes mellitus, hypertension, dislipidemia and OSAS.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Complications</measure>
    <time_frame>2 years</time_frame>
    <description>Complications will be divided in short-term complications (within 30 days after operation) and long-term complications (after 30 days). All adverse event will be registered.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>The quality of life will be assessed by using the BAROS.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>Standard RYGB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard RYGB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extended Pouch RYGB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Restrictive/extended pouch RYGB</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Extended Pouch RYGB</intervention_name>
    <arm_group_label>Extended Pouch RYGB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard RYGB</intervention_name>
    <arm_group_label>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;
        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>Jens Homan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rijnstate Hospital Arnhem</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <state>Gelderland</state>
        <zip>6800WC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</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, Morbid</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/NCT02218957
org study id: ExtPouch
nct id: NCT02218957
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 a restrictive/extended pouch on
      weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the
      restrictive/extended pouch 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 (normal pouch) and restrictive/extended pouch 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: Change in comorbidities
time frame: 2 years
description: Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:
comorbidity resolved
comorbidity improved
comorbidity unchanged
comorbidity worsened
This will be done for diabetes mellitus, hypertension, dislipedimia and OSAS.
measure: Change in comorbidities
time frame: 2 years
description: Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:
comorbidity resolved
comorbidity improved
comorbidity unchanged
comorbidity worsened
This will be done for diabetes mellitus, hypertension, dislipidemia and OSAS.
measure: Complications
time frame: 2 years
description: Complications will be divided in short-term complications (within 30 days after operation) and long-term complications (after 30 days). All adverse event will be registered.
measure: Quality of life
time frame: 2 years
description: The quality of life will be assessed by using the BAROS.
arm group label: Standard RYGB
arm group type: Active Comparator
description: Standard RYGB
arm group label: Extended Pouch RYGB
arm group type: Experimental
description: Restrictive/extended pouch RYGB
intervention type: Procedure
intervention name: Extended Pouch RYGB
arm group label: Extended Pouch RYGB
intervention type: Procedure
intervention name: Standard RYGB
arm group label: Standard RYGB
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jens Homan, MD
role: Principal Investigator
affiliation: Rijnstate Hospital Arnhem
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Obesity, Morbid