<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/NCT03236142</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 016-16</org_study_id>
    <nct_id>NCT03236142</nct_id>
  </id_info>
  <brief_title>DS vs SIPS-Bariatric Surgery Comparasion</brief_title>
  <official_title>The Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) Results in Less Nutritional Deficiencies Than the Standard Duodenal Switch (DS) Operation: A Multicenter, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Reading Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Reading Health System</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>
      The aim of this study is to answer the question of whether the single anastomosis, 300 cm&#xD;
      loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less&#xD;
      nutritional and surgical risks than the standard duodenal switch (DS) operation. Please note,&#xD;
      this study does not provide a stipend or coverage for surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">January 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2023</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vitamin A Deficiency</measure>
    <time_frame>36 months post surgery</time_frame>
    <description>Proportion of patients with a vitamin A deficiency</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vitamin D, zinc, copper, and albumin</measure>
    <time_frame>36 months post surgery</time_frame>
    <description>Proportion of patients with vitamin D, zinc, copper, and albumin deficiency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of stools</measure>
    <time_frame>36 months post surgery</time_frame>
    <description>Amount of stools per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Operation</measure>
    <time_frame>Date of operation</time_frame>
    <description>Length of surgical procedure in time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of excess weight lost</measure>
    <time_frame>36 months post surgery</time_frame>
    <description>Weight in excess of a body mass index (BMI) of 25.0 lost</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>36 months post surgery</time_frame>
    <description>Body mass index (weight in kilograms divided by height in meters squared</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>Standard Duodenal Switch (DS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SIPS Operation</intervention_name>
    <description>The SIPS modification of the DS operation entails one less division of the small intestine and one less anastomosis, thereby reducing the time of the procedure.</description>
    <arm_group_label>Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Duodenal Switch Operation</intervention_name>
    <arm_group_label>Standard Duodenal Switch (DS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) of 40 to 65&#xD;
&#xD;
          -  Agree to not use weight loss medications for the length of the study&#xD;
&#xD;
          -  Compliance with standards of surgical program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of previous bariatric surgery except for patients who have had&#xD;
             a previous gastric sleeve&#xD;
&#xD;
          -  Previous complex abdominal surgery&#xD;
&#xD;
          -  Poorly controlled medical or psychiatric disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Reading Health Physician Network Weight Management Center</name>
      <address>
        <city>West Reading</city>
        <state>Pennsylvania</state>
        <zip>19611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Malissa Sullivan Bariatric Coordinator</last_name>
      <phone>484-628-3141</phone>
      <email>Malissa.Sullivan@towerhealth.org</email>
    </contact>
    <contact_backup>
      <last_name>Stephan Myers Principal Investigator</last_name>
      <phone>484-628-3064</phone>
      <email>stephan.myers@towerhealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Stephan Myers, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Leon Katz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>June 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2018</last_update_submitted>
  <last_update_submitted_qc>August 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Reading Health System</investigator_affiliation>
    <investigator_full_name>Stephan Myers, MD</investigator_full_name>
    <investigator_title>Stephan Myers, MD, FACS, Medical Director, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>bariatric</keyword>
  <keyword>duodenal switch</keyword>
  <keyword>DS</keyword>
  <keyword>weight loss surgery</keyword>
  <keyword>SIPS</keyword>
  <keyword>Single Anastomosis</keyword>
  <!-- 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/NCT03236142
org study id: IRB 016-16
nct id: NCT03236142
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to answer the question of whether the single anastomosis, 300 cm
      loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less
      nutritional and surgical risks than the standard duodenal switch (DS) operation. Please note,
      this study does not provide a stipend or coverage for surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Vitamin A Deficiency
time frame: 36 months post surgery
description: Proportion of patients with a vitamin A deficiency
measure: Vitamin D, zinc, copper, and albumin
time frame: 36 months post surgery
description: Proportion of patients with vitamin D, zinc, copper, and albumin deficiency
measure: Frequency of stools
time frame: 36 months post surgery
description: Amount of stools per day
measure: Length of Operation
time frame: Date of operation
description: Length of surgical procedure in time
measure: Percentage of excess weight lost
time frame: 36 months post surgery
description: Weight in excess of a body mass index (BMI) of 25.0 lost
measure: Body Mass Index (BMI)
time frame: 36 months post surgery
description: Body mass index (weight in kilograms divided by height in meters squared
arm group label: Standard Duodenal Switch (DS)
arm group type: Active Comparator
arm group label: Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS)
arm group type: Experimental
intervention type: Procedure
intervention name: SIPS Operation
description: The SIPS modification of the DS operation entails one less division of the small intestine and one less anastomosis, thereby reducing the time of the procedure.
arm group label: Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS)
intervention type: Procedure
intervention name: Standard Duodenal Switch Operation
arm group label: Standard Duodenal Switch (DS)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Reading Health System
investigator full name: Stephan Myers, MD
investigator title: Stephan Myers, MD, FACS, Medical Director, Principal Investigator