<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/NCT01732159</url>
  </required_header>
  <id_info>
    <org_study_id>K110601</org_study_id>
    <nct_id>NCT01732159</nct_id>
  </id_info>
  <brief_title>Impact of a Checklist on the Rate of Late Cancellation in Ambulatory Surgery</brief_title>
  <acronym>AMBUPROG</acronym>
  <official_title>Impact of a Checklist on the Rate of Late Cancellation in Ambulatory Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the impact of a check list on the rate of late&#xD;
      cancellation, i.e. the day before or the day of the ambulatory surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The checklist is administered to the patients by phone between 7 and 3 days before the&#xD;
      surgery. Each item of the checklist is associated with a decisional algorithm that allows&#xD;
      take care for patients in case of any problem.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">January 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease in the rate of late cancellation</measure>
    <time_frame>At day 0 (the day of the surgery)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of the organization of the ambulatory unit</measure>
    <time_frame>At day 0 (the day of the surgery)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4093</enrollment>
  <condition>Ambulatory Surgery Programmed</condition>
  <arm_group>
    <arm_group_label>Administration of the checklist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be contacted by phone for administration of the checklist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No contact by phone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who will not be contacted by phone</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Checklist</intervention_name>
    <description>he checklist will be administered to the patients by phone between 7 and 3 days before the surgery</description>
    <arm_group_label>Administration of the checklist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient (adult or minor) for which ambulatory surgery is programmed in a multipurpose&#xD;
             ASU&#xD;
&#xD;
          -  Surgery under general anesthesia or loco&#xD;
&#xD;
          -  Regional or neuroleptanalgesia3. Patient contacted by phone&#xD;
&#xD;
          -  Patient does not oppose his participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient programmed for endoscopy in ASU non surgical&#xD;
&#xD;
          -  Ambulatory surgery scheduled for orthogenic&#xD;
&#xD;
          -  Ambulatory surgery scheduled for urgency&#xD;
&#xD;
          -  Ambulatory surgery performed under local anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Pierre BETHOUX, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cochin Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cochin Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>April 20, 2015</last_update_submitted>
  <last_update_submitted_qc>April 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ambulatory surgery</keyword>
  <keyword>Checklist</keyword>
  <keyword>Cancellation</keyword>
  <!-- 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/NCT01732159
org study id: K110601
nct id: NCT01732159
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the impact of a check list on the rate of late
      cancellation, i.e. the day before or the day of the ambulatory surgery.
The checklist is administered to the patients by phone between 7 and 3 days before the
      surgery. Each item of the checklist is associated with a decisional algorithm that allows
      take care for patients in case of any problem.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Decrease in the rate of late cancellation
time frame: At day 0 (the day of the surgery)
measure: Improvement of the organization of the ambulatory unit
time frame: At day 0 (the day of the surgery)
arm group label: Administration of the checklist
arm group type: Experimental
description: Patients will be contacted by phone for administration of the checklist
arm group label: No contact by phone
arm group type: No Intervention
description: Patients who will not be contacted by phone
intervention type: Other
intervention name: Checklist
description: he checklist will be administered to the patients by phone between 7 and 3 days before the surgery
arm group label: Administration of the checklist
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jean-Pierre BETHOUX, MD, PhD
role: Principal Investigator
affiliation: Cochin Hospital
facility: 
country: France
responsible party type: Sponsor