xml: <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/NCT05975775</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00622-43</org_study_id>
      <nct_id>NCT05975775</nct_id>
    </id_info>
    <brief_title>Outpatient Laparoscopic Radical Prostatectomy</brief_title>
    <acronym>LORP</acronym>
    <official_title>Study of Postoperative Complications After Laparoscopic Outpatient Radical Prostatectomy in Patients With Localized Prostate Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GCS Ramsay Santé pour l'Enseignement et la Recherche</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>GCS Ramsay Santé pour l'Enseignement et la Recherche</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study is to evaluate the incidence of surgery-related complications&#xD;
        between Day 0 and Day 30.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an observational, prospective, open, non-comparative (single arm), bicentric study.&#xD;
  &#xD;
        This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic&#xD;
        radical prostatectomy has been validated at a multidisciplinary consultation meeting. The&#xD;
        possibility of performing this procedure on an outpatient basis is left to the surgeon's&#xD;
        discretion, according to well-defined medical procedure criteria.&#xD;
  &#xD;
        This cohort is part of the usual care. The study will observe the incidence and describe the&#xD;
        type, number, severity, duration and frequency of procedure-related complications that may&#xD;
        arise in the first month post-op of ambulatory Laparoscopic Radical Prostatectomy. For this&#xD;
        reason, patient follow-up will stop at 1 month after surgery, during a routine follow-up&#xD;
        visit.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Incidence of complications</measure>
      <time_frame>30 days</time_frame>
      <description>The primary endpoint was the incidence of procedural complications between Day 0 and Day 30.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>ambulatory patient cohort</arm_group_label>
      <description>Patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Laparoscopic radical prostatectomy</intervention_name>
      <description>Prostate cancer may require laparoscopic radical prostatectomy, a surgical procedure performed under general anaesthetic.</description>
      <arm_group_label>ambulatory patient cohort</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic&#xD;
          radical prostatectomy has been validated at a multidisciplinary consultation meeting.&#xD;
          Ambulatory management is at the surgeon's discretion, according to well-defined medical&#xD;
          procedure criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male, age ≥ 18 years;&#xD;
  &#xD;
            -  Localized prostate cancer;&#xD;
  &#xD;
            -  Validation in a multidisciplinary consultation meeting of curative treatment;&#xD;
  &#xD;
            -  Scheduled laparoscopic radical prostatectomy;&#xD;
  &#xD;
            -  Patient able to understand the information related to the study, to read the&#xD;
               information leaflet and to signify his/her non-opposition or opposition to&#xD;
               participating in the study;&#xD;
  &#xD;
            -  Membership of a social security scheme;&#xD;
  &#xD;
            -  Patient having been informed and having given oral non-opposition.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Surgical emergency;&#xD;
  &#xD;
            -  Patient not eligible for ambulatory care;&#xD;
  &#xD;
            -  Long-term curative anti-coagulant treatment;&#xD;
  &#xD;
            -  Resident more than 100km from the clinic;&#xD;
  &#xD;
            -  Home alone the first night;&#xD;
  &#xD;
            -  Patient under guardianship, curatorship or deprivation of liberty.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Arnaud BALDINI, MD</last_name>
      <phone>469001019</phone>
      <phone_ext>+33</phone_ext>
      <email>docteur.baldini@urolyon-ouest.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinique de la Sauvegarde</name>
        <address>
          <city>Lyon</city>
          <zip>69009</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Arnaud BALDINI, MD</last_name>
        <email>docteur.baldini@urolyon-ouest.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975775
  org study id: 2023-A00622-43
  nct id: NCT05975775
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to evaluate the incidence of surgery-related complications
        between Day 0 and Day 30.
  This is an observational, prospective, open, non-comparative (single arm), bicentric study.
  
        This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic
        radical prostatectomy has been validated at a multidisciplinary consultation meeting. The
        possibility of performing this procedure on an outpatient basis is left to the surgeon's
        discretion, according to well-defined medical procedure criteria.
  
        This cohort is part of the usual care. The study will observe the incidence and describe the
        type, number, severity, duration and frequency of procedure-related complications that may
        arise in the first month post-op of ambulatory Laparoscopic Radical Prostatectomy. For this
        reason, patient follow-up will stop at 1 month after surgery, during a routine follow-up
        visit.
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence of complications
  time frame: 30 days
  description: The primary endpoint was the incidence of procedural complications between Day 0 and Day 30.
  arm group label: ambulatory patient cohort
  description: Patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting.
  intervention type: Procedure
  intervention name: Laparoscopic radical prostatectomy
  description: Prostate cancer may require laparoscopic radical prostatectomy, a surgical procedure performed under general anaesthetic.
  arm group label: ambulatory patient cohort
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Arnaud BALDINI, MD
  phone: 469001019
  phone ext: +33
  email: docteur.baldini@urolyon-ouest.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms