<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/NCT03240250</url>
  </required_header>
  <id_info>
    <org_study_id>3564</org_study_id>
    <nct_id>NCT03240250</nct_id>
  </id_info>
  <brief_title>Randomized Study on Effects of Uniportal VATS Versus Triportal VATS</brief_title>
  <official_title>Randomized Study on Effects of Uniportal VATS Versus Triportal VATS for the Treatment of Stage I-II NSCLC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</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>
      For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized:&#xD;
      uni-portal and three-portal VATS. In the uniportal approach, the injury on a single&#xD;
      intercostal space could determine a lower level of pain than the three-portal approach,&#xD;
      allowing a better postoperative course. Few studies in Literature compare these techniques,&#xD;
      and most of them are retrospective.&#xD;
&#xD;
      The main purpose of this randomized study is to compare uni-portal VATS with three-portal&#xD;
      VATS, in terms of postoperative pain.&#xD;
&#xD;
      Secondary objectives of the study are valutations of:&#xD;
&#xD;
        -  respiratory and functional capacity between the two groups&#xD;
&#xD;
        -  operative time&#xD;
&#xD;
        -  number of resected lymphnodes&#xD;
&#xD;
        -  intra and postoperative complications, such as conversions to open surgery, amount of&#xD;
           bleeding, prolonged air leaks, surgical site infections, pulmonary complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized cohort clinical trial, prospectic, monocentric. Procedure of randomization: the&#xD;
      day before the operation, with the &quot;Random Allocation Rule&quot; technique&#xD;
&#xD;
      Arm 1: pulmonary lobectomy and lymphoadenectomy with uni-portal VATS approach&#xD;
&#xD;
      Arm 2: pulmonary lobectomy and lymphoadenectomy with three-portal VATS approach&#xD;
&#xD;
      Misurations Total analgesic consumption, normalized to morphine milligrams, recorded in the 7&#xD;
      days following the operation.&#xD;
&#xD;
      The choice of cumulative analgesic consumption as parameter of primary outcome is because&#xD;
      pain valuation with VAS is significantly affected by individual variability.&#xD;
&#xD;
      Secondary outcomes: measure of postoperative pain with NRS at 2,6,12,24 hours and at&#xD;
      2,3,4,5,30 days from sugery. A pain score will be assigned to each patient after the total&#xD;
      amount of NRS.&#xD;
&#xD;
      Respiratory function will be valuated with spirometry after 7 and 30 days from surgery, and&#xD;
      compared with pre-operative tests.&#xD;
&#xD;
      All intraoperative parameters will be compared between the two groups: operative time (skin&#xD;
      to skin), proportion of conversions to open surgery, number of resected lymphnodes, amount of&#xD;
      bleeding.&#xD;
&#xD;
      Postoperative complications will be analyzed: rate of prolonged air leaks, surgical site&#xD;
      infections, cardiac rythhm disfunctions, pulmonary complications, post-thoracotomy syndrome,&#xD;
      as well as lenght of stay at the hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2017</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of postoperative pain after uni-portal and three-portal VATS</measure>
    <time_frame>7 days</time_frame>
    <description>Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery.</measure>
    <time_frame>30 days</time_frame>
    <description>A pain score will be assigned to each patient after the total amount of NRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valuation of respiratory function</measure>
    <time_frame>30 days</time_frame>
    <description>Spirometry after 7 and 30 days from surgery, compared with pre-operative tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative parameters</measure>
    <time_frame>1 day</time_frame>
    <description>Operative time (skin to skin, minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative bleeding</measure>
    <time_frame>1 day</time_frame>
    <description>Amount of bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative air leakage</measure>
    <time_frame>15 days</time_frame>
    <description>Rate of prolonged air leaks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>1 month</time_frame>
    <description>Cardiac rythhm disfunctions</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Uni-portal VATS</arm_group_label>
    <description>VATS uni-portal lobectomy and lymphoadenectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Three-portal VATS</arm_group_label>
    <description>VATS three-portal lobectomy and lymphoadenectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>VATS uni-portal lobectomy and lymphoadenectomy</intervention_name>
    <description>VATS uni-portal lobectomy and lymphoadenectomy</description>
    <arm_group_label>Uni-portal VATS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>VATS three-portal lobectomy and lymphoadenectomy</intervention_name>
    <description>VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach</description>
    <arm_group_label>Three-portal VATS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with clinical diagnosis of NSCLC, stage I-II, age 30-75, who undergo pulmonary&#xD;
        lobectomy and limphadenectomy with radical intent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cT1-2N0-1M0 NSCLC, maximum diameter 5cm&#xD;
&#xD;
          -  ASA (American Society of Anestesiology) score 1-2-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N2-N3 disease&#xD;
&#xD;
          -  Induction chemotherapy&#xD;
&#xD;
          -  Thoracic wall infiltration&#xD;
&#xD;
          -  Previous thoracic surgery&#xD;
&#xD;
          -  Important pleural adhesions&#xD;
&#xD;
          -  Severe COPD, asthma, interstitial lung disease - Liver, kidney or cardiac failure&#xD;
&#xD;
          -  Clotting disorders&#xD;
&#xD;
          -  Analgesic allergy&#xD;
&#xD;
          -  Sublobar resection, sleeve lobectomy, pneumonectomy&#xD;
&#xD;
          -  Chronic analgesic, oppioids or cortisonic use&#xD;
&#xD;
          -  Absence of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Davide Tosi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione Ca' Granda IRCCS Policlinico Milan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thoracic Surgery Unit - Fondazione IRCCS Ca' Granda Policlinico</name>
      <address>
        <city>Milan</city>
        <state>Mi</state>
        <zip>20100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>VATS</keyword>
  <keyword>Pulmonary lobectomy</keyword>
  <keyword>Uniportal</keyword>
  <keyword>Postoperative pain</keyword>
  <keyword>Thoracic surgery</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/NCT03240250
org study id: 3564
nct id: NCT03240250
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized:
      uni-portal and three-portal VATS. In the uniportal approach, the injury on a single
      intercostal space could determine a lower level of pain than the three-portal approach,
      allowing a better postoperative course. Few studies in Literature compare these techniques,
      and most of them are retrospective.

      The main purpose of this randomized study is to compare uni-portal VATS with three-portal
      VATS, in terms of postoperative pain.

      Secondary objectives of the study are valutations of:

        -  respiratory and functional capacity between the two groups

        -  operative time

        -  number of resected lymphnodes

        -  intra and postoperative complications, such as conversions to open surgery, amount of
           bleeding, prolonged air leaks, surgical site infections, pulmonary complications.
Randomized cohort clinical trial, prospectic, monocentric. Procedure of randomization: the
      day before the operation, with the "Random Allocation Rule" technique

      Arm 1: pulmonary lobectomy and lymphoadenectomy with uni-portal VATS approach

      Arm 2: pulmonary lobectomy and lymphoadenectomy with three-portal VATS approach

      Misurations Total analgesic consumption, normalized to morphine milligrams, recorded in the 7
      days following the operation.

      The choice of cumulative analgesic consumption as parameter of primary outcome is because
      pain valuation with VAS is significantly affected by individual variability.

      Secondary outcomes: measure of postoperative pain with NRS at 2,6,12,24 hours and at
      2,3,4,5,30 days from sugery. A pain score will be assigned to each patient after the total
      amount of NRS.

      Respiratory function will be valuated with spirometry after 7 and 30 days from surgery, and
      compared with pre-operative tests.

      All intraoperative parameters will be compared between the two groups: operative time (skin
      to skin), proportion of conversions to open surgery, number of resected lymphnodes, amount of
      bleeding.

      Postoperative complications will be analyzed: rate of prolonged air leaks, surgical site
      infections, cardiac rythhm disfunctions, pulmonary complications, post-thoracotomy syndrome,
      as well as lenght of stay at the hospital.
observational model: Cohort
time perspective: Prospective
measure: Measurement of postoperative pain after uni-portal and three-portal VATS
time frame: 7 days
description: Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.
measure: Measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery.
time frame: 30 days
description: A pain score will be assigned to each patient after the total amount of NRS
measure: Valuation of respiratory function
time frame: 30 days
description: Spirometry after 7 and 30 days from surgery, compared with pre-operative tests
measure: Intraoperative parameters
time frame: 1 day
description: Operative time (skin to skin, minutes)
measure: Intraoperative bleeding
time frame: 1 day
description: Amount of bleeding
measure: Postoperative air leakage
time frame: 15 days
description: Rate of prolonged air leaks
measure: Postoperative complications
time frame: 1 month
description: Cardiac rythhm disfunctions
arm group label: Uni-portal VATS
description: VATS uni-portal lobectomy and lymphoadenectomy
arm group label: Three-portal VATS
description: VATS three-portal lobectomy and lymphoadenectomy
intervention type: Procedure
intervention name: VATS uni-portal lobectomy and lymphoadenectomy
description: VATS uni-portal lobectomy and lymphoadenectomy
arm group label: Uni-portal VATS
intervention type: Procedure
intervention name: VATS three-portal lobectomy and lymphoadenectomy
description: VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach
arm group label: Three-portal VATS
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Davide Tosi
role: Principal Investigator
affiliation: Fondazione Ca' Granda IRCCS Policlinico Milan
facility: 
country: Italy
responsible party type: Sponsor
sharing ipd: No