<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/NCT03003169</url>
  </required_header>
  <id_info>
    <org_study_id>ICL OBS 01</org_study_id>
    <nct_id>NCT03003169</nct_id>
  </id_info>
  <brief_title>Mastectomy in Ambulatory Breast Surgery</brief_title>
  <acronym>MASTAMBU</acronym>
  <official_title>Mastectomy in Ambulatory Breast Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de Lorraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Cancérologie de Lorraine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective observational study, involving 550 mastectomies in Lorraine Institute&#xD;
      of Oncology, to assess care patients management of ambulatory surgical compared to standard&#xD;
      surgery procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 8, 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Impact of the type of hospitalization (ambulatory / conventional) according to the type of surgery (total / partial mastectomy) on quality of life 15 days after Intervention.</measure>
    <time_frame>15 days</time_frame>
    <description>Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of type of hospitalization (ambulatory / conventional) depending on the type of surgery (total / partial mastectomy) on anxiety / depression of the patient 15 days after surgery.</measure>
    <time_frame>15 days</time_frame>
    <description>Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)</measure>
    <time_frame>15 days</time_frame>
    <description>Patient satisfaction is assessed by a satisfaction care questionnaire (PATSAT 32).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate within 15 days the intervention according to the type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)</measure>
    <time_frame>15 jours</time_frame>
    <description>Postoperative complications will be classified according to Dindo- Clavien</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the conversion rate from ambulatory surgical to conventional surgery</measure>
    <time_frame>15 jours</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">419</enrollment>
  <condition>Mastectomy</condition>
  <arm_group>
    <arm_group_label>ambulatory surgery description</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical questionnaire</intervention_name>
    <description>quality of life questionnaire (EORTC QLQ-C30 and QLQ-BR23)&#xD;
Hospital Anxiety and Depression scale&#xD;
satisfaction care questionnaire (IN-PATSAT32)</description>
    <arm_group_label>ambulatory surgery description</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population includes all the patients managed for total or partial mastectomy at the&#xD;
        institute.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient managed for breast cancer surgery&#xD;
&#xD;
          -  age &gt;18 years old&#xD;
&#xD;
          -  understand and comply with the requirements of the study&#xD;
&#xD;
          -  patient must be affiliated to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient managed for a concomitant reconstructive surgery&#xD;
&#xD;
          -  bilateral breast surgery&#xD;
&#xD;
          -  patient already included in another clinical trial with an experimental molecule&#xD;
&#xD;
          -  men&#xD;
&#xD;
          -  patient deprived of liberty or under supervision&#xD;
&#xD;
          -  neoadjuvant therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARCHAL FREDERIC, MD, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Cancérologie de Lorraine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Hejl L, Raft J, Leufflen L, Rauch P, Buhler J, Abel-Decollogne F, Routiot T, Hotton J, Salleron J, Marchal F. Quality of life, anxiety, and postoperative complications of patients undergoing breast cancer surgery as ambulatory surgery compared to non-ambulatory surgery: A prospective non-randomized study. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101779. doi: 10.1016/j.jogoh.2020.101779. Epub 2020 May 11.</citation>
    <PMID>32407900</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>surgery</keyword>
  <keyword>breast cancer</keyword>
  <keyword>quality of life</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/NCT03003169
org study id: ICL OBS 01
nct id: NCT03003169
lead sponsor: 
has dmc: No
This is a prospective observational study, involving 550 mastectomies in Lorraine Institute
      of Oncology, to assess care patients management of ambulatory surgical compared to standard
      surgery procedure.
observational model: Cohort
time perspective: Prospective
measure: Impact of the type of hospitalization (ambulatory / conventional) according to the type of surgery (total / partial mastectomy) on quality of life 15 days after Intervention.
time frame: 15 days
description: Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23
measure: Impact of type of hospitalization (ambulatory / conventional) depending on the type of surgery (total / partial mastectomy) on anxiety / depression of the patient 15 days after surgery.
time frame: 15 days
description: Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale
measure: Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)
time frame: 15 days
description: Patient satisfaction is assessed by a satisfaction care questionnaire (PATSAT 32).
measure: Complication rate within 15 days the intervention according to the type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)
time frame: 15 jours
description: Postoperative complications will be classified according to Dindo- Clavien
measure: Estimate the conversion rate from ambulatory surgical to conventional surgery
time frame: 15 jours
arm group label: ambulatory surgery description
intervention type: Other
intervention name: Medical questionnaire
description: quality of life questionnaire (EORTC QLQ-C30 and QLQ-BR23)
Hospital Anxiety and Depression scale
satisfaction care questionnaire (IN-PATSAT32)
arm group label: ambulatory surgery description
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MARCHAL FREDERIC, MD, PU-PH
role: Principal Investigator
affiliation: Institut de Cancérologie de Lorraine
facility: 
country: France
citation: Hejl L, Raft J, Leufflen L, Rauch P, Buhler J, Abel-Decollogne F, Routiot T, Hotton J, Salleron J, Marchal F. Quality of life, anxiety, and postoperative complications of patients undergoing breast cancer surgery as ambulatory surgery compared to non-ambulatory surgery: A prospective non-randomized study. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101779. doi: 10.1016/j.jogoh.2020.101779. Epub 2020 May 11.
PMID: 32407900
responsible party type: Sponsor
sharing ipd: No