<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/NCT04431583</url>
  </required_header>
  <id_info>
    <org_study_id>13204</org_study_id>
    <nct_id>NCT04431583</nct_id>
  </id_info>
  <brief_title>Transition of Single Surgeon Bariatric Service to an Interdisciplinary Multiple Surgeon Model</brief_title>
  <official_title>Transition of Single Surgeon Bariatric Service to an Interdisciplinary Multiple Surgeon Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Adelaide</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Central Adelaide Local Health Network Incorporated</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Adelaide</source>
  <oversight_info>
    <has_dmc>No</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>
      This retrospective study will analyse the transition of an Australian hospital which&#xD;
      significantly increased volume of bariatric operations after introduction of a clinical&#xD;
      pathway, and to assess the outcomes. Barriers to introduction of the multidisciplinary&#xD;
      pathway and the means to overcome these will also be analysed and discussed. The analysis&#xD;
      will also determine if there are any other areas of bariatric surgery which can be further&#xD;
      investigated to optimise current practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2008</start_date>
  <completion_date type="Actual">June 3, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative length of stay (nights)</measure>
    <time_frame>The number of nights the participant stay in hospital from the day of procedure to the day of hospital discharge. This time period occurs immediately after the procedure. This data will be retrospectively reviewed on an average of 5 years.</time_frame>
    <description>This will be measured in number of nights the participant stayed in hospital after the procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End weight loss</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Post-operative weight loss</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>End weight loss</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Post-operative weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End weight loss</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Post-operative weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative time</measure>
    <time_frame>The start time of the operation to the end time of the procedure. This data will be retrospectively reviewed on an average of 5 years.</time_frame>
    <description>Duration of operative time measured in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Complications which occurred in the post operative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of operations performed in time period</measure>
    <time_frame>Retrospectively reviewed, 1 yearly</time_frame>
    <description>The number of operations which occurred in each group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of Operation Performed</measure>
    <time_frame>Retrospectively reviewed, 1 yearly</time_frame>
    <description>The number of the different types of bariatric operations which occurred in each group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants converted from Gastric Sleeve to Gastric Bypass</measure>
    <time_frame>Retrospectively reviewed, 1 yearly</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients on surgical waitlist</measure>
    <time_frame>Retrospectively reviewed, 1 yearly</time_frame>
    <description>The number of patients on the surgical waitlist for each time period</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">146</enrollment>
  <condition>Obesity</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>2008-2012 Participants</arm_group_label>
    <description>Participants who underwent bariatric surgery between 2008 and 2012 (inclusive).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2013-2016 Participants</arm_group_label>
    <description>Participants who underwent bariatric surgery between 2013 and 2016 (inclusive).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2017- 2018 Participants</arm_group_label>
    <description>Participants who underwent bariatric surgery between 2017 and 2018 (inclusive).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric surgery- single surgeon service</intervention_name>
    <arm_group_label>2008-2012 Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric surgery- multiple surgeon + multidisciplinary team approach</intervention_name>
    <arm_group_label>2013-2016 Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approach</intervention_name>
    <arm_group_label>2017- 2018 Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent bariatric surgery at the Queen Elizabeth Hospital (South Australia)&#xD;
        between the years of 2008 and 2018.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have had bariatric surgery at The Queen Elizabeth Hospital between&#xD;
             2008-2018&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  nil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Barbaro, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Adelaide</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Harsh Kanhere, MS, FRACS, AFRACMA</last_name>
    <role>Study Director</role>
    <affiliation>Central Adelaide Local Health Network</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Markus Trochsler, MD, FMH, MMIS, FRACS</last_name>
    <role>Study Director</role>
    <affiliation>Central Adelaide Local Health Network</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gayatri Asokan, MBBS, FRACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Adelaide Local Health Network</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matheesha Herath, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Adelaide Local Health Network</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raghav Goel, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Adelaide Local Health Network</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Adelaide</investigator_affiliation>
    <investigator_full_name>Antonio Barbaro</investigator_full_name>
    <investigator_title>Associate Clinical Lecturer</investigator_title>
  </responsible_party>
  <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/NCT04431583
org study id: 13204
nct id: NCT04431583
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This retrospective study will analyse the transition of an Australian hospital which
      significantly increased volume of bariatric operations after introduction of a clinical
      pathway, and to assess the outcomes. Barriers to introduction of the multidisciplinary
      pathway and the means to overcome these will also be analysed and discussed. The analysis
      will also determine if there are any other areas of bariatric surgery which can be further
      investigated to optimise current practice.
observational model: Cohort
time perspective: Retrospective
measure: Post-operative length of stay (nights)
time frame: The number of nights the participant stay in hospital from the day of procedure to the day of hospital discharge. This time period occurs immediately after the procedure. This data will be retrospectively reviewed on an average of 5 years.
description: This will be measured in number of nights the participant stayed in hospital after the procedure.
measure: End weight loss
time frame: Up to 12 months
description: Post-operative weight loss
measure: End weight loss
time frame: Up to 24 months
description: Post-operative weight loss
measure: End weight loss
time frame: Up to 36 months
description: Post-operative weight loss
measure: Intraoperative time
time frame: The start time of the operation to the end time of the procedure. This data will be retrospectively reviewed on an average of 5 years.
description: Duration of operative time measured in minutes
measure: Post-operative complications
time frame: Up to 36 months
description: Complications which occurred in the post operative period
measure: Number of operations performed in time period
time frame: Retrospectively reviewed, 1 yearly
description: The number of operations which occurred in each group
measure: Type of Operation Performed
time frame: Retrospectively reviewed, 1 yearly
description: The number of the different types of bariatric operations which occurred in each group
measure: Number of participants converted from Gastric Sleeve to Gastric Bypass
time frame: Retrospectively reviewed, 1 yearly
measure: Number of patients on surgical waitlist
time frame: Retrospectively reviewed, 1 yearly
description: The number of patients on the surgical waitlist for each time period
arm group label: 2008-2012 Participants
description: Participants who underwent bariatric surgery between 2008 and 2012 (inclusive).
arm group label: 2013-2016 Participants
description: Participants who underwent bariatric surgery between 2013 and 2016 (inclusive).
arm group label: 2017- 2018 Participants
description: Participants who underwent bariatric surgery between 2017 and 2018 (inclusive).
intervention type: Procedure
intervention name: Bariatric surgery- single surgeon service
arm group label: 2008-2012 Participants
intervention type: Procedure
intervention name: Bariatric surgery- multiple surgeon + multidisciplinary team approach
arm group label: 2013-2016 Participants
intervention type: Procedure
intervention name: Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approach
arm group label: 2017- 2018 Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Antonio Barbaro, MBBS
role: Principal Investigator
affiliation: University of Adelaide
last name: Harsh Kanhere, MS, FRACS, AFRACMA
role: Study Director
affiliation: Central Adelaide Local Health Network
last name: Markus Trochsler, MD, FMH, MMIS, FRACS
role: Study Director
affiliation: Central Adelaide Local Health Network
last name: Gayatri Asokan, MBBS, FRACS
role: Principal Investigator
affiliation: Central Adelaide Local Health Network
last name: Matheesha Herath, MBBS
role: Principal Investigator
affiliation: Central Adelaide Local Health Network
last name: Raghav Goel, MBBS
role: Principal Investigator
affiliation: Central Adelaide Local Health Network
responsible party type: Principal Investigator
investigator affiliation: University of Adelaide
investigator full name: Antonio Barbaro
investigator title: Associate Clinical Lecturer
sharing ipd: No