<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/NCT01715402</url>
  </required_header>
  <id_info>
    <org_study_id>AOM 11060</org_study_id>
    <nct_id>NCT01715402</nct_id>
  </id_info>
  <brief_title>Optimization of Health Expenditure in Liver Surgery</brief_title>
  <official_title>Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to reduce the length of stay after liver surgery by taking account&#xD;
      of objective quantitative clinical variables, subjective qualitative clinical variables and&#xD;
      non clinical variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      a new dimension of the activity expected of physicians is to improve the safety of care on&#xD;
      the one hand and the control of health care costs on the other.&#xD;
&#xD;
      key measures to help them are the publication of national recommendations, assessment of&#xD;
      actual practices and the incentive to activity.&#xD;
&#xD;
      Internationalwide recent and concordant data suggest that&#xD;
&#xD;
        -  quality and security of care, after an initial improvement, are going to stall&#xD;
&#xD;
        -  scientific recommendations are rarely validated by an impact analysis and are not&#xD;
           applied&#xD;
&#xD;
        -  clinical data collected within an administrative framework are unreliable and too&#xD;
           generalist&#xD;
&#xD;
        -  the evaluation, especially in the surgical field, is based on indicators sometimes&#xD;
           irrelevant and often unclear&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>overall postoperative length of stay</measure>
    <time_frame>during the 3 months after the surgery</time_frame>
    <description>the overall postoperative length of stay is defined as the hospitalization between the surgery and patient's discharge.&#xD;
This period includes the readmission for at least 24 hours in case of outcomes related to the surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>peroperative outcomes</measure>
    <time_frame>during the surgical procedure</time_frame>
    <description>the peroperative outcomes are collected during the surgery and correspond to any event occured during the surgical intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative outcomes</measure>
    <time_frame>after the surgery until postoperative month 3</time_frame>
    <description>the postoperative outcomes correspond to any event occured after the surgical intervention. These outcomes include fistulae; bleeding...</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>construct of pronostic models</measure>
    <time_frame>after the postoperative month 3</time_frame>
    <description>the construct of pronostic models include variables that affect the length of stay; morbidity and mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of PMSI indicators</measure>
    <time_frame>after the postoperative month 3</time_frame>
    <description>this evaluation includes the analysis of PMSI indicators; their validity and the influence of centres on hepatectomies results</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Hilar Cholangiocarcinoma</condition>
  <condition>Intra Hepatic Cholangiocarcinoma</condition>
  <condition>Liver Metastasis</condition>
  <arm_group>
    <arm_group_label>operated patients</arm_group_label>
    <description>this cohort includes patients who underwent a liver surgery whatever the pathology and whatever the surgical procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>liver surgery</intervention_name>
    <description>this intervention type includes hepatectomies; wedge; segmentectomies etc...</description>
    <arm_group_label>operated patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the population corresponds to patients operated in one of the thirteen hospitals.&#xD;
&#xD;
        These hospitals are distributed on the french territory to ensure that the recruitment is&#xD;
        representative of the general population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective liver surgery&#xD;
&#xD;
          -  older than 18&#xD;
&#xD;
          -  agreed to participate&#xD;
&#xD;
          -  surgical procedure included procedures registered as &quot;HLFA003 - 007 ; 009 - 011 ; 017&#xD;
             - 020 ; HLFC002 à 004 ; 027 ; 032 ; 037&quot; in the PMSI database&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  refused to participate&#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>Olivier FARGES, MD, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beaujon University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amiens North Hospital</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bordeaux Hospital</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaujon University Hospital</name>
      <address>
        <city>Clichy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lille Regional Hospital</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyon Hospital</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marseille Hospital</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paoli calmette institute</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Antoine Hospital</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strasbourg hospital</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy institute</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paul Brousse Hospital</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>February 3, 2017</last_update_submitted>
  <last_update_submitted_qc>February 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>liver tumor</keyword>
  <keyword>carcinoma</keyword>
  <keyword>cholangiocarcinoma</keyword>
  <keyword>metastasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Klatskin Tumor</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/NCT01715402
org study id: AOM 11060
nct id: NCT01715402
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to reduce the length of stay after liver surgery by taking account
      of objective quantitative clinical variables, subjective qualitative clinical variables and
      non clinical variables.
a new dimension of the activity expected of physicians is to improve the safety of care on
      the one hand and the control of health care costs on the other.

      key measures to help them are the publication of national recommendations, assessment of
      actual practices and the incentive to activity.

      Internationalwide recent and concordant data suggest that

        -  quality and security of care, after an initial improvement, are going to stall

        -  scientific recommendations are rarely validated by an impact analysis and are not
           applied

        -  clinical data collected within an administrative framework are unreliable and too
           generalist

        -  the evaluation, especially in the surgical field, is based on indicators sometimes
           irrelevant and often unclear
observational model: Cohort
time perspective: Prospective
measure: overall postoperative length of stay
time frame: during the 3 months after the surgery
description: the overall postoperative length of stay is defined as the hospitalization between the surgery and patient's discharge.
This period includes the readmission for at least 24 hours in case of outcomes related to the surgery.
measure: peroperative outcomes
time frame: during the surgical procedure
description: the peroperative outcomes are collected during the surgery and correspond to any event occured during the surgical intervention
measure: postoperative outcomes
time frame: after the surgery until postoperative month 3
description: the postoperative outcomes correspond to any event occured after the surgical intervention. These outcomes include fistulae; bleeding...
measure: construct of pronostic models
time frame: after the postoperative month 3
description: the construct of pronostic models include variables that affect the length of stay; morbidity and mortality
measure: evaluation of PMSI indicators
time frame: after the postoperative month 3
description: this evaluation includes the analysis of PMSI indicators; their validity and the influence of centres on hepatectomies results
arm group label: operated patients
description: this cohort includes patients who underwent a liver surgery whatever the pathology and whatever the surgical procedure
intervention type: Procedure
intervention name: liver surgery
description: this intervention type includes hepatectomies; wedge; segmentectomies etc...
arm group label: operated patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier FARGES, MD, phD
role: Principal Investigator
affiliation: Beaujon University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Cholangiocarcinoma
mesh term: Klatskin Tumor