<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/NCT03290339</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A01505-48</org_study_id>
    <nct_id>NCT03290339</nct_id>
  </id_info>
  <brief_title>Feasibility of Ambulatory Hysterectomy</brief_title>
  <acronym>AMETHYST</acronym>
  <official_title>Preliminary Study About the Feasibility of Ambulatory Hysterectomy: Bicentric Study in Caen UH and Amiens UH</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amiens University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Caen</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Hysterectomy is one of the most performed surgery in women. Public authorities wish that&#xD;
      one-day surgery become a majority and hysterectomy could be part of it in the future. The aim&#xD;
      of this study is to determine the feasibility of ambulatory hysterectomy.&#xD;
&#xD;
      Patients and methods: Investigators will realize an observational descriptive survey based on&#xD;
      questionnaires in two surgical gynecology units. Women under 70 years old, who undergo&#xD;
      hysterectomy will be included.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Anticipated">December 6, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 6, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>PADSS score</measure>
    <time_frame>Day 0 post surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>Day 1</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hysterectomy</intervention_name>
    <description>laparoscopic hysterectomy and vaginal hysterectomy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women more than 18 and Under 70 years old who undergo hysterectomy by laparoscopy or&#xD;
        vaginal procedure in one the two units&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women, undergo surgery for hysterectomy by laparoscopy or vaginal procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  comorbidities included: heart disease, anti-coagulant treatment, anti-aggregant&#xD;
             treatment; sleep apnea syndrome, laparotomy laparoconversion if hysterectomy&#xD;
             associated with appendectomy and/or, omentectomy and/or, lymph nodes dissection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>raffaele Fauvet, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Caen UH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fabien CHAILLOT</last_name>
    <phone>+33 2 31 06 57 74</phone>
    <email>chaillot-f@chu-caen.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Caen university hospital</name>
      <address>
        <city>Caen</city>
        <state>Calvados</state>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>fabien Chaillot</last_name>
      <phone>+33 2 31 06 57 74</phone>
      <email>chaillot-f@chu-caen.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Caen</investigator_affiliation>
    <investigator_full_name>Raffaele FAUVET</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>one-day surgery</keyword>
  <keyword>hysterectomy</keyword>
  <keyword>ambulatory</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/NCT03290339
org study id: 2017-A01505-48
nct id: NCT03290339
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hysterectomy is one of the most performed surgery in women. Public authorities wish that
      one-day surgery become a majority and hysterectomy could be part of it in the future. The aim
      of this study is to determine the feasibility of ambulatory hysterectomy.

      Patients and methods: Investigators will realize an observational descriptive survey based on
      questionnaires in two surgical gynecology units. Women under 70 years old, who undergo
      hysterectomy will be included.
observational model: Cohort
time perspective: Prospective
measure: PADSS score
time frame: Day 0 post surgery
measure: patient satisfaction
time frame: Day 1
description: questionnaire
intervention type: Procedure
intervention name: hysterectomy
description: laparoscopic hysterectomy and vaginal hysterectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: raffaele Fauvet, MD, PhD
role: Principal Investigator
affiliation: Caen UH
last name: Fabien CHAILLOT
phone: +33 2 31 06 57 74
email: chaillot-f@chu-caen.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Caen
investigator full name: Raffaele FAUVET
investigator title: professor
sharing ipd: No