<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/NCT04453176</url>
  </required_header>
  <id_info>
    <org_study_id>LOCAL/2018/PC-01</org_study_id>
    <nct_id>NCT04453176</nct_id>
  </id_info>
  <brief_title>Evaluation of the Satisfaction of Patients Coming &quot;on Foot&quot; in the Operating Room</brief_title>
  <acronym>Bloc3D</acronym>
  <official_title>Evaluation of the Satisfaction of Patients Coming &quot;on Foot&quot; in the Operating Room (Standing, Dignified, Relaxed)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</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>
      Ambulatory surgery is currently experiencing unprecedented growth and is becoming the&#xD;
      standard of care compared to traditional hospitalization. Without mentioning the obvious&#xD;
      financial gains, the benefits of ambulatory care essentially lie in optimised perioperative&#xD;
      comfort. This comfort is due to a limited period of stay (&lt; 12 hours) and to the proactive&#xD;
      action of the care providers.&#xD;
&#xD;
      In this context, the optimization of the whole patient's journey during the perioperative&#xD;
      period has been reviewed and adapted to personalized management within healthcare facilities.&#xD;
      For more than a year now, multimodal approaches such as early rehabilitation have been&#xD;
      undertaken, including&#xD;
&#xD;
        -  morning admission with an innovative principle of &quot;3D&quot; patient (standing, dignified,&#xD;
           relaxed)&#xD;
&#xD;
        -  no premedication, wearing glasses and wigs,&#xD;
&#xD;
        -  Drinking on the morning of the intervention (2H before admission),&#xD;
&#xD;
        -  Walking to the block on foot (or in a wheelchair), return adapted to the wheelchair and&#xD;
           no longer in a stretcher,&#xD;
&#xD;
        -  fast resumption of feeding.&#xD;
&#xD;
      Currently, in the investigator's various institutions, several modes of transport to the&#xD;
      operating theatres coexist. The purpose of this observational study is to evaluate this&#xD;
      optimization of perioperative management &quot;3D mode&quot;, in particular the mode of transport.&#xD;
&#xD;
      The main objective is to determine the level of patient satisfaction with this management&#xD;
      using a standardized quality questionnaire: the &quot;EVAN&quot; questionnaire. This questionnaire&#xD;
      contains 22 items allowing a global analysis of patient satisfaction. This questionnaire is&#xD;
      already routinely conducted in many institutions. The EVAN questionnaire will be supplemented&#xD;
      by questionnaires assessing the level of perioperative anxiety. They will be initiated into&#xD;
      the anesthesia consultation, and finalized on the day of the surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Satisfaction of day case surgery: EVAN-G score</measure>
    <time_frame>Day 0</time_frame>
    <description>Satisfaction is measured with an EVAN-G score (1-100 points)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Anesthesiology</condition>
  <condition>Satisfaction, Patient</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>operating block admission &quot;on foot&quot;</arm_group_label>
    <description>Patient going to the oparating block on foot</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard operating block admission</arm_group_label>
    <description>Patient going to the operating room in a conventional way (stretcher)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Satisfaction</intervention_name>
    <description>Patient satisfaction evaluated with EVAN G questionnaire</description>
    <arm_group_label>operating block admission &quot;on foot&quot;</arm_group_label>
    <arm_group_label>standard operating block admission</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients included in the study are patients at least 18 years old, hospitalized for&#xD;
        scheduled surgery, who have accepted the principle of the study, are able to complete the&#xD;
        EVAN-G questionnaire and are able to walk alone.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 yars&#xD;
&#xD;
          -  Consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  ASA &gt;4&#xD;
&#xD;
          -  Difficulties in French reading, incapacity to complete questionnaire&#xD;
&#xD;
          -  patient in a wheelchair or stretcher or having difficulty walking alone&#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>Blandine Fayard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nimes, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Nimes</name>
      <address>
        <city>Nîmes</city>
        <state>Gard</state>
        <zip>30 000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Juge</name>
      <address>
        <city>Marseille</city>
        <zip>13000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut paoli Calmette</name>
      <address>
        <city>Marseille</city>
        <zip>13000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Montpellier - Saint-Eloi</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de cancerologie de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04453176
org study id: LOCAL/2018/PC-01
nct id: NCT04453176
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ambulatory surgery is currently experiencing unprecedented growth and is becoming the
      standard of care compared to traditional hospitalization. Without mentioning the obvious
      financial gains, the benefits of ambulatory care essentially lie in optimised perioperative
      comfort. This comfort is due to a limited period of stay (< 12 hours) and to the proactive
      action of the care providers.

      In this context, the optimization of the whole patient's journey during the perioperative
      period has been reviewed and adapted to personalized management within healthcare facilities.
      For more than a year now, multimodal approaches such as early rehabilitation have been
      undertaken, including

        -  morning admission with an innovative principle of "3D" patient (standing, dignified,
           relaxed)

        -  no premedication, wearing glasses and wigs,

        -  Drinking on the morning of the intervention (2H before admission),

        -  Walking to the block on foot (or in a wheelchair), return adapted to the wheelchair and
           no longer in a stretcher,

        -  fast resumption of feeding.

      Currently, in the investigator's various institutions, several modes of transport to the
      operating theatres coexist. The purpose of this observational study is to evaluate this
      optimization of perioperative management "3D mode", in particular the mode of transport.

      The main objective is to determine the level of patient satisfaction with this management
      using a standardized quality questionnaire: the "EVAN" questionnaire. This questionnaire
      contains 22 items allowing a global analysis of patient satisfaction. This questionnaire is
      already routinely conducted in many institutions. The EVAN questionnaire will be supplemented
      by questionnaires assessing the level of perioperative anxiety. They will be initiated into
      the anesthesia consultation, and finalized on the day of the surgery.
observational model: Cohort
time perspective: Prospective
measure: Satisfaction of day case surgery: EVAN-G score
time frame: Day 0
description: Satisfaction is measured with an EVAN-G score (1-100 points)
arm group label: operating block admission "on foot"
description: Patient going to the oparating block on foot
arm group label: standard operating block admission
description: Patient going to the operating room in a conventional way (stretcher)
intervention type: Other
intervention name: Patient Satisfaction
description: Patient satisfaction evaluated with EVAN G questionnaire
arm group label: operating block admission "on foot"
arm group label: standard operating block admission
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Blandine Fayard, MD
role: Principal Investigator
affiliation: CHU Nimes, France
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No