<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/NCT03024294</url>
  </required_header>
  <id_info>
    <org_study_id>2016P002308</org_study_id>
    <nct_id>NCT03024294</nct_id>
  </id_info>
  <brief_title>Care Pathway for Patients Undergoing VATS Lobectomy or Segmentectomy</brief_title>
  <official_title>Care Pathway for Patients Undergoing VATS Lobectomy or Segmentectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <brief_summary>
    <textblock>
      The goal of this study is to create a unified SOP for care of subjects undergoing VATS&#xD;
      lobectomy and segmentectomy by members of the Division of Thoracic Surgery. Other academic&#xD;
      centers have created standardized algorithms for the care of their subjects and this enables&#xD;
      the centers to determine which subjects can be placed on an accelerated pathway to discharge&#xD;
      and which cannot. Some of these SOPS dictate uniform treatment algorithms with reduction in&#xD;
      what may be unnecessary tests to simplify patient care and likely accelerate them towards&#xD;
      safe and more timely discharge from the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, study to develop, test, fine-tune and refine an SOP for the&#xD;
      post-operative care for patients who undergo a VATS lobectomy or segmentectomy performed by&#xD;
      one of the surgeons in The Division of Thoracic Surgery. This study will be conducted in two&#xD;
      phases. Phase 1 will be focused on early feasibility of the SOP and this will be done by&#xD;
      enrolling 50 participants among the subgroup of Thoracic VATS Surgeons who participate. An&#xD;
      analysis will take place upon the completion of the phase 1 to look at the percentage of&#xD;
      participants who were able to be discharged on or prior to POD 3. Upon this analysis,&#xD;
      modifications across all areas of the care pathway will be evaluated and altered if deemed&#xD;
      necessary by the PI and other members of the study team. This analysis will drive any&#xD;
      modifications needed that will be incorporated into the phase II design prior to its&#xD;
      implementation. The treating Thoracic Surgeon for each patient will follow the SOP as it is&#xD;
      outlined and the steps the post-operative team will follow will be dependent on which phase&#xD;
      the participant is enrolled too. Data will be collected for each participant starting just&#xD;
      prior to the VATS operation and continue through the discharge and conclude once the&#xD;
      participants have reached their 90-day post-discharge date. Upon discharge from the hospital&#xD;
      the participant will enter the follow-up period of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary objective is to evaluate feasibility of this SOP in two phases. The primary objective of phase 1 is to determine the POD 3 rate, defined as proportion of patients who are discharged by midnight on POD 3.</measure>
    <time_frame>From date of consent until midnight of post op day 3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The primary objective of phase II is to further evaluate this SOP. The study team will also have the opportunity to refine and fine tune this SOP between phase I and phase II.</measure>
    <time_frame>From date of consent until midnight of post op day 3</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>VATS Lobectomy</condition>
  <condition>VATS Segmentectomy</condition>
  <condition>Care Pathway</condition>
  <condition>Lung Nodule</condition>
  <arm_group>
    <arm_group_label>Patients undergoing VATS lobectomy or segmentectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients undergoing VATS lobectomy or segmentectomy performed by one of the surgeons in the Division of Thoracic Surgery who are then placed on this specific post-operative care pathway to determine the rate of discharge of these patients by post-operative day (POD) three.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomy</intervention_name>
    <description>To place participants on this specific post-operative care pathway upon the completion of their VATS surgery to determine the discharge rate by midnight on post-operative day (POD) three.</description>
    <arm_group_label>Patients undergoing VATS lobectomy or segmentectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Subjects planned to undergo a VATS lobectomy or segmentectomy procedure for lung&#xD;
             nodules&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who cannot undergo VATS surgery&#xD;
&#xD;
          -  Subjects undergoing any kind of resection in addition to VATS Lobectomy or&#xD;
             Segmentectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Swanson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>July 12, 2018</last_update_submitted>
  <last_update_submitted_qc>July 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Scott J Swanson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03024294
org study id: 2016P002308
nct id: NCT03024294
lead sponsor: 
The goal of this study is to create a unified SOP for care of subjects undergoing VATS
      lobectomy and segmentectomy by members of the Division of Thoracic Surgery. Other academic
      centers have created standardized algorithms for the care of their subjects and this enables
      the centers to determine which subjects can be placed on an accelerated pathway to discharge
      and which cannot. Some of these SOPS dictate uniform treatment algorithms with reduction in
      what may be unnecessary tests to simplify patient care and likely accelerate them towards
      safe and more timely discharge from the hospital.
This is a prospective, study to develop, test, fine-tune and refine an SOP for the
      post-operative care for patients who undergo a VATS lobectomy or segmentectomy performed by
      one of the surgeons in The Division of Thoracic Surgery. This study will be conducted in two
      phases. Phase 1 will be focused on early feasibility of the SOP and this will be done by
      enrolling 50 participants among the subgroup of Thoracic VATS Surgeons who participate. An
      analysis will take place upon the completion of the phase 1 to look at the percentage of
      participants who were able to be discharged on or prior to POD 3. Upon this analysis,
      modifications across all areas of the care pathway will be evaluated and altered if deemed
      necessary by the PI and other members of the study team. This analysis will drive any
      modifications needed that will be incorporated into the phase II design prior to its
      implementation. The treating Thoracic Surgeon for each patient will follow the SOP as it is
      outlined and the steps the post-operative team will follow will be dependent on which phase
      the participant is enrolled too. Data will be collected for each participant starting just
      prior to the VATS operation and continue through the discharge and conclude once the
      participants have reached their 90-day post-discharge date. Upon discharge from the hospital
      the participant will enter the follow-up period of the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The primary objective is to evaluate feasibility of this SOP in two phases. The primary objective of phase 1 is to determine the POD 3 rate, defined as proportion of patients who are discharged by midnight on POD 3.
time frame: From date of consent until midnight of post op day 3
measure: The primary objective of phase II is to further evaluate this SOP. The study team will also have the opportunity to refine and fine tune this SOP between phase I and phase II.
time frame: From date of consent until midnight of post op day 3
arm group label: Patients undergoing VATS lobectomy or segmentectomy
arm group type: Other
description: Patients undergoing VATS lobectomy or segmentectomy performed by one of the surgeons in the Division of Thoracic Surgery who are then placed on this specific post-operative care pathway to determine the rate of discharge of these patients by post-operative day (POD) three.
intervention type: Other
intervention name: Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomy
description: To place participants on this specific post-operative care pathway upon the completion of their VATS surgery to determine the discharge rate by midnight on post-operative day (POD) three.
arm group label: Patients undergoing VATS lobectomy or segmentectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Scott Swanson, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Scott J Swanson
investigator title: Principal Investigator