<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/NCT01709877</url>
  </required_header>
  <id_info>
    <org_study_id>AOUP_1</org_study_id>
    <secondary_id>RF-2009-1535329</secondary_id>
    <nct_id>NCT01709877</nct_id>
  </id_info>
  <brief_title>EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach</brief_title>
  <official_title>Randomised Non-inferiority Trial of Laparoscopic Cholecystectomy Performed With EndoCone Single Port Versus Conventional Multi-port Laparoscopic Approach Using Clinical, PROMS and Health Economic Endpoints</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliero, Universitaria Pisana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regione Toscana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Scuola Superiore Sant'Anna di Pisa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Università di Pisa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliero, Universitaria Pisana</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Its main objective is to evaluate the clinical outcome (including patient reported outcomes)&#xD;
      and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic&#xD;
      Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled&#xD;
      prospective clinical trial (RCT) on specific operations performed (on a random allocation&#xD;
      basis) by either the traditional multi-port laparoscopic approach or the Single Port-&#xD;
      ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion&#xD;
      criteria will be randomised over a three year period to have the operation by either of the&#xD;
      two approaches.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">July 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Conversion rate</measure>
    <time_frame>During the intervention</time_frame>
    <description>1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morbidity</measure>
    <time_frame>30 days</time_frame>
    <description>1 = if the patient has surgical complications 0 = no complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative course</measure>
    <time_frame>1 week</time_frame>
    <description>pain, measured using 1) visual linear analogue scale and 2) analgesic administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>6 days</time_frame>
    <description>Date of the operation Date of hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return of bowel function</measure>
    <time_frame>12, 24, 48 hours</time_frame>
    <description>Passage of flatus and/or bowel motion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Gallstones</condition>
  <arm_group>
    <arm_group_label>Traditional multiport laparoscopic cholecystectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard laparoscopic cholecystectomy performed by the traditional multiport technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single port laparoscopic cholecystectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cholecystectomy</intervention_name>
    <description>Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease</description>
    <arm_group_label>Single port laparoscopic cholecystectomy</arm_group_label>
    <arm_group_label>Traditional multiport laparoscopic cholecystectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic gallstone disease&#xD;
&#xD;
          -  ASA I/II&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA III or more&#xD;
&#xD;
          -  significant co-morbid cardiovascular, neurological diseases, diabetics and chronic&#xD;
             obstructive airway disease&#xD;
&#xD;
          -  patients with previous history of invasive cancer&#xD;
&#xD;
          -  patients with previous surgery&#xD;
&#xD;
          -  patients requiring urgent/emergency interventions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franco Mosca, Prof, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AOUP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alfred Cuschieri, Prof, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scuola Superiore Sant'Anna di Pisa</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Franco Mosca, Prof. MD</last_name>
    <phone>+39 (0)50 996820</phone>
    <email>f.mosca@med.unipi.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Giovanni Caprili, MD</last_name>
    <phone>+39 3286875111</phone>
    <email>mabcap@libero.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ospedale San Donato</name>
      <address>
        <city>Arezzo</city>
        <state>AR</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fabio Sbrana, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale Campo di Marte</name>
      <address>
        <city>Lucca</city>
        <state>LU</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Andrea Carobbi, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedinale di Cisanello</name>
      <address>
        <city>Pisa</city>
        <state>PI</state>
        <zip>56100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luca Morelli, MD</last_name>
      <phone>+39 (0)50 996820</phone>
      <email>llmorelli74@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale Felice Lotti</name>
      <address>
        <city>Pontedera</city>
        <state>PI</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Orlando Goletti, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>June 28, 2013</last_update_submitted>
  <last_update_submitted_qc>June 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 1, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero, Universitaria Pisana</investigator_affiliation>
    <investigator_full_name>Franco Mosca</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Multiport laparoscopy</keyword>
  <keyword>Single Port Laparoscopy</keyword>
  <keyword>Symptomatic Gallstones</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01709877
org study id: AOUP_1
secondary id: RF-2009-1535329
nct id: NCT01709877
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Its main objective is to evaluate the clinical outcome (including patient reported outcomes)
      and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic
      Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled
      prospective clinical trial (RCT) on specific operations performed (on a random allocation
      basis) by either the traditional multi-port laparoscopic approach or the Single Port-
      ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion
      criteria will be randomised over a three year period to have the operation by either of the
      two approaches.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Conversion rate
time frame: During the intervention
description: 1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port
measure: Morbidity
time frame: 30 days
description: 1 = if the patient has surgical complications 0 = no complications
measure: Mortality
time frame: 30 days
measure: Postoperative course
time frame: 1 week
description: pain, measured using 1) visual linear analogue scale and 2) analgesic administration
measure: Duration of hospital stay
time frame: 6 days
description: Date of the operation Date of hospital discharge
measure: Return of bowel function
time frame: 12, 24, 48 hours
description: Passage of flatus and/or bowel motion
arm group label: Traditional multiport laparoscopic cholecystectomy
arm group type: Active Comparator
description: Standard laparoscopic cholecystectomy performed by the traditional multiport technique
arm group label: Single port laparoscopic cholecystectomy
arm group type: Experimental
description: Laparoscopic cholecystectomy performed using the reusable ENDOCONE system with dedicated curved coaxial instruments
intervention type: Procedure
intervention name: Cholecystectomy
description: Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease
arm group label: Single port laparoscopic cholecystectomy
arm group label: Traditional multiport laparoscopic cholecystectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Franco Mosca, Prof, MD
role: Principal Investigator
affiliation: AOUP
last name: Alfred Cuschieri, Prof, MD
role: Principal Investigator
affiliation: Scuola Superiore Sant'Anna di Pisa
last name: Franco Mosca, Prof. MD
phone: +39 (0)50 996820
email: f.mosca@med.unipi.it
last name: Giovanni Caprili, MD
phone: +39 3286875111
email: mabcap@libero.it
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliero, Universitaria Pisana
investigator full name: Franco Mosca
investigator title: Prof.
mesh term: Gallstones
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis