<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/NCT01722279</url>
  </required_header>
  <id_info>
    <org_study_id>10070</org_study_id>
    <nct_id>NCT01722279</nct_id>
  </id_info>
  <brief_title>The Long Term Impact of Bariatric Surgery on Quality of Life</brief_title>
  <official_title>The Long Term Impact of Bariatric Surgery on Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascension St. Vincent Carmel Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ascension St. Vincent Carmel Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to examine the breadth, nature, and factors affecting&#xD;
      the long term changes in physical and psychological health and quality of life (QOL)&#xD;
      following bariatric surgery. Data will be gathered via electronic survey (SurveyMonkey),&#xD;
      postal mail, or phone, or using a standardized questionnaire expected to last 25-35 minutes.&#xD;
      Archival data available from patient medical records will also be gathered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Information from existing databases and medical records will be used to obtain a list of&#xD;
      phone numbers for persons who had roux-en-y bariatric surgery at the SVBCE five or more years&#xD;
      ago at the St. Vincent Bariatric Center of Excellence (SVBCE. The interview includes scripts&#xD;
      that the caller will use to recruit subjects in either direct conversation, in voice mail or&#xD;
      by leaving a message. Recruitment will cease after 400 complete post pilot interviews are&#xD;
      obtained.&#xD;
&#xD;
      The interview covers topics related to physical and psychological health and quality of life.&#xD;
      The number of questions asked will vary from subject to subject since some questions are&#xD;
      asked only if a prior question is answered affirmatively. For example, if a subject responds&#xD;
      &quot;yes&quot; when asked &quot;have you had plastic surgery?&quot; the subject is then asked what type of&#xD;
      procedure they had. The topics covered are as follows: weight, current health, post surgery&#xD;
      complications, relationships, work, cross addiction, mental health, diet, television viewing,&#xD;
      exercise, and life satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Flourishing Scale (Diener et al, 2009)</measure>
    <time_frame>5 or more years after bariatric surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with Life Scale (Diener et al, 1985)</measure>
    <time_frame>5 or more years after bariatric surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship satisfaction</measure>
    <time_frame>At least 5 years post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance abuse and behavioral excesses</measure>
    <time_frame>At least 5 years post-surgery</time_frame>
    <description>Assesses presence of alcohol or other drug use problems, excessive spending, and problematic gambling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Health Problems</measure>
    <time_frame>At least 5 years post-surgery</time_frame>
    <description>Assesses presence of various obesity-related health problems including diabetes, hypertension, heart disease, stroke, hich cholesterol, sleep apnea, joint pain, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight history</measure>
    <time_frame>At least 5 years post-surgery</time_frame>
    <description>Assesses pre-surgery weight, current weight, and lowest post-surgical weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with surgery</measure>
    <time_frame>At least 5 years post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contact with Bariatric Center caregivers</measure>
    <time_frame>At least 5 years post-surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">414</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Bariatric surgery patients, at least 5 years post-surgery</arm_group_label>
    <description>Survey participants had bariatric surgery at the St. Vincent Bariatric Center of Excellence at least 5 years before completing survey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric surgery</intervention_name>
    <arm_group_label>Bariatric surgery patients, at least 5 years post-surgery</arm_group_label>
    <other_name>roux-en-y gastric bypass</other_name>
    <other_name>gastric band</other_name>
    <other_name>biliopancreatic diversion with duodenal switch</other_name>
    <other_name>vertical banded gastroplasty</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Bariatric surgery patients of the St. Vincent Bariatric Center of Excellence who had&#xD;
        surgery at least 5 years before the survey was administered.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bariatric surgery patients of the St. Vincent Bariatric Center of Excellence who had&#xD;
             surgery at least 5 years before the survey was administered.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having bariatric surgery at facilities other than St. Vincent Bariatric&#xD;
             Center.&#xD;
&#xD;
          -  Patients who had bariatric surgery less than 5 years before the survey period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leslie M Schuh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Vincent Carmel Bariatric Center of Excellence</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Vincent Carmel Hospital Bariatric Center of Excellence</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bariatric surgery</keyword>
  <keyword>long-term outcomes</keyword>
  <keyword>obesity</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/NCT01722279
org study id: 10070
nct id: NCT01722279
lead sponsor: 
has dmc: No
The primary purpose of this study is to examine the breadth, nature, and factors affecting
      the long term changes in physical and psychological health and quality of life (QOL)
      following bariatric surgery. Data will be gathered via electronic survey (SurveyMonkey),
      postal mail, or phone, or using a standardized questionnaire expected to last 25-35 minutes.
      Archival data available from patient medical records will also be gathered.
Information from existing databases and medical records will be used to obtain a list of
      phone numbers for persons who had roux-en-y bariatric surgery at the SVBCE five or more years
      ago at the St. Vincent Bariatric Center of Excellence (SVBCE. The interview includes scripts
      that the caller will use to recruit subjects in either direct conversation, in voice mail or
      by leaving a message. Recruitment will cease after 400 complete post pilot interviews are
      obtained.

      The interview covers topics related to physical and psychological health and quality of life.
      The number of questions asked will vary from subject to subject since some questions are
      asked only if a prior question is answered affirmatively. For example, if a subject responds
      "yes" when asked "have you had plastic surgery?" the subject is then asked what type of
      procedure they had. The topics covered are as follows: weight, current health, post surgery
      complications, relationships, work, cross addiction, mental health, diet, television viewing,
      exercise, and life satisfaction.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Flourishing Scale (Diener et al, 2009)
time frame: 5 or more years after bariatric surgery
measure: Satisfaction with Life Scale (Diener et al, 1985)
time frame: 5 or more years after bariatric surgery
measure: Relationship satisfaction
time frame: At least 5 years post-surgery
measure: Substance abuse and behavioral excesses
time frame: At least 5 years post-surgery
description: Assesses presence of alcohol or other drug use problems, excessive spending, and problematic gambling
measure: Physical Health Problems
time frame: At least 5 years post-surgery
description: Assesses presence of various obesity-related health problems including diabetes, hypertension, heart disease, stroke, hich cholesterol, sleep apnea, joint pain, etc.
measure: Weight history
time frame: At least 5 years post-surgery
description: Assesses pre-surgery weight, current weight, and lowest post-surgical weight.
measure: Satisfaction with surgery
time frame: At least 5 years post-surgery
measure: Contact with Bariatric Center caregivers
time frame: At least 5 years post-surgery
arm group label: Bariatric surgery patients, at least 5 years post-surgery
description: Survey participants had bariatric surgery at the St. Vincent Bariatric Center of Excellence at least 5 years before completing survey.
intervention type: Procedure
intervention name: Bariatric surgery
arm group label: Bariatric surgery patients, at least 5 years post-surgery
other name: roux-en-y gastric bypass
other name: gastric band
other name: biliopancreatic diversion with duodenal switch
other name: vertical banded gastroplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leslie M Schuh, PhD
role: Principal Investigator
affiliation: St. Vincent Carmel Bariatric Center of Excellence
facility: 
country: United States
responsible party type: Sponsor