<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/NCT03004560</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00075024</org_study_id>
    <nct_id>NCT03004560</nct_id>
  </id_info>
  <brief_title>Psychology of Minimally Invasive Surgical Scars</brief_title>
  <official_title>Psychology of Minimally Invasive Surgical Scars</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Teleflex</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the psychological and psychosocial impact of surgical&#xD;
      scars after minimally invasive surgery (MIS). 100 adult patients who are about to undergo&#xD;
      bariatric procedures through the Duke Metabolic &amp; Weight Loss Surgery program will be&#xD;
      enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic&#xD;
      surgery and 50 will be assigned to the percutaneous group. All patients will complete&#xD;
      pre-operative psychometric testing to establish a baseline body-image score as well as a&#xD;
      patient's initial subjective perceptions around surgery and surgical scars. Follow-up visits&#xD;
      will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after&#xD;
      surgery. Subjects will complete the same psychometric measures to identify differences in&#xD;
      psychological and psychosocial responses to standard laparoscopic and percutaneous scars.&#xD;
      Patients will also complete a measure on scar satisfaction. The investigators hope to&#xD;
      identify any differences between standard laparoscopic versus percutaneous approaches.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Scar satisfaction</measure>
    <time_frame>Baseline, 3 weeks, 3 months, 6 months and 1 year post-op</time_frame>
    <description>Patients will complete a scar assessment at post-op and routine follow up visits at 3 weeks, 3 months, 6 months, and 1 year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Abdominal pain scale</measure>
    <time_frame>Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op</time_frame>
    <description>Patients will complete an abdominal pain scale (0-10) at post-op and routine follow up visits at 3 weeks, 3 months, 6 months, and 1 year.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Psychometric testing questionnaire</measure>
    <time_frame>Baseline, 3 weeks, 3 months, 6 months and 1 year post-op</time_frame>
    <description>Psychometric testing will be performed to obtain a body image score and to see how/if that changes over time.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Standard Laparoscopic Approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Minimally invasive laparoscopic procedure with 5-10 mm incisions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Percutaneous Approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Minimally invasive laparoscopic procedure with 2-3 mm incisions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Laparoscopic Approach</intervention_name>
    <description>Minimally invasive laparoscopic surgery with 5-10 mm incisions.</description>
    <arm_group_label>Standard Laparoscopic Approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Approach</intervention_name>
    <description>Minimally invasive laparoscopic surgery with 2-3 mm incisions.</description>
    <arm_group_label>Percutaneous Approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index 35 to 45&#xD;
&#xD;
          -  Undergoing Bariatric Surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index &lt;35 or &gt;45&#xD;
&#xD;
          -  Previous Bariatric Surgery&#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>Dana Portenier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Center for Metabolic and Weight Loss Surgery</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bariatric</keyword>
  <keyword>standard laparoscopic surgery</keyword>
  <keyword>minimally invasive</keyword>
  <keyword>scars</keyword>
  <keyword>psychology</keyword>
  <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/NCT03004560
org study id: Pro00075024
nct id: NCT03004560
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to examine the psychological and psychosocial impact of surgical
      scars after minimally invasive surgery (MIS). 100 adult patients who are about to undergo
      bariatric procedures through the Duke Metabolic & Weight Loss Surgery program will be
      enrolled in this study. 50 patients will be randomly assigned to standard laparoscopic
      surgery and 50 will be assigned to the percutaneous group. All patients will complete
      pre-operative psychometric testing to establish a baseline body-image score as well as a
      patient's initial subjective perceptions around surgery and surgical scars. Follow-up visits
      will be done at standard of care timepoints - 3 weeks, 3 and 6 months, and 1 year after
      surgery. Subjects will complete the same psychometric measures to identify differences in
      psychological and psychosocial responses to standard laparoscopic and percutaneous scars.
      Patients will also complete a measure on scar satisfaction. The investigators hope to
      identify any differences between standard laparoscopic versus percutaneous approaches.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Scar satisfaction
time frame: Baseline, 3 weeks, 3 months, 6 months and 1 year post-op
description: Patients will complete a scar assessment at post-op and routine follow up visits at 3 weeks, 3 months, 6 months, and 1 year.
measure: Change in the Abdominal pain scale
time frame: Baseline, 1 day post-op, 3 weeks, 3 months, 6 months and 1 year post-op
description: Patients will complete an abdominal pain scale (0-10) at post-op and routine follow up visits at 3 weeks, 3 months, 6 months, and 1 year.
measure: Change in Psychometric testing questionnaire
time frame: Baseline, 3 weeks, 3 months, 6 months and 1 year post-op
description: Psychometric testing will be performed to obtain a body image score and to see how/if that changes over time.
arm group label: Standard Laparoscopic Approach
arm group type: Active Comparator
description: Minimally invasive laparoscopic procedure with 5-10 mm incisions.
arm group label: Percutaneous Approach
arm group type: Active Comparator
description: Minimally invasive laparoscopic procedure with 2-3 mm incisions.
intervention type: Procedure
intervention name: Standard Laparoscopic Approach
description: Minimally invasive laparoscopic surgery with 5-10 mm incisions.
arm group label: Standard Laparoscopic Approach
intervention type: Procedure
intervention name: Percutaneous Approach
description: Minimally invasive laparoscopic surgery with 2-3 mm incisions.
arm group label: Percutaneous Approach
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dana Portenier, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No