<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/NCT03292549</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2012/30</org_study_id>
    <nct_id>NCT03292549</nct_id>
  </id_info>
  <brief_title>RObotic PArtial Nephrectomy National Study</brief_title>
  <acronym>ROPAN</acronym>
  <official_title>RObotic PArtial Nephrectomy National Study (RoPaN Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</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>
      The purpose of the study is to set up the larger prospective study on robotic partial&#xD;
      nephrectomy, to describe the characteristics of patients operated for kidney cancer by this&#xD;
      surgical procedure and also to determine the modalities of hemostasis in this procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the study is to describe the characteristics of patients operated&#xD;
      for kidney cancer by a robotic partial nephrectomy in France (recruiting centers, patient&#xD;
      profile, tumor characteristics).&#xD;
&#xD;
      Secondary Objective(s):&#xD;
&#xD;
        1. To describe the surgical techniques and operative development.&#xD;
&#xD;
        2. To assess the modalities of haemostasis, during robotic partial nephrectomy.&#xD;
&#xD;
        3. To assess peri-operative morbidity in robotic partial nephrectomy and post-operative&#xD;
           complications.&#xD;
&#xD;
        4. To assess the outcome of renal function after a robotic partial nephrectomy. This study&#xD;
           is a national, multicenter, prospective, cohort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Post-operative complications evaluated according to the Clavien criteria</measure>
    <time_frame>From surgery until 1 year of follow up</time_frame>
    <description>Per and post-operative transfusion rates</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative complications evaluated according to the Clavien criteria</measure>
    <time_frame>From surgery until 1 year of follow up</time_frame>
    <description>Medical or surgical complication rates</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative complications evaluated according to the Clavien criteria</measure>
    <time_frame>From surgery until 1 year of follow up</time_frame>
    <description>Clavien's grading</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative complications evaluated according to the Clavien criteria</measure>
    <time_frame>From surgery until 1 year of follow up</time_frame>
    <description>Urinary fistula rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative complications evaluated according to the Clavien criteria</measure>
    <time_frame>From surgery until 1 year of follow up</time_frame>
    <description>Necessity for nephrectomy or re-exploration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative complications evaluated according to the Clavien criteria</measure>
    <time_frame>From surgery until 1 year of follow up</time_frame>
    <description>Length of hospital stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal function after robotic partial nephrectomy measured by biological parameters</measure>
    <time_frame>Follow-up during 12 months</time_frame>
    <description>Creatininemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function after robotic partial nephrectomy measured by biological parameters</measure>
    <time_frame>Follow-up during 12 months</time_frame>
    <description>MDRD GFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Per-operative modalities of haemostasis procedure</measure>
    <time_frame>At Surgery</time_frame>
    <description>Haemostasis procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Per-operative modalities of haemostatic agent</measure>
    <time_frame>At Surgery</time_frame>
    <description>Haemostatic agent</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">452</enrollment>
  <condition>Kidney Cancer</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Robotic partial surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robotic partial surgery</intervention_name>
    <description>Robotic partial surgery</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients operated for kidney cancer by this surgical procedure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is at least 18 years old at the time of screening&#xD;
&#xD;
          -  Subject has been diagnosed with renal tumor(s)&#xD;
&#xD;
          -  Subject will undergo a robot assisted partial nephrectomy&#xD;
&#xD;
          -  Subject is willing and able to comply with the requirements of the protocol&#xD;
&#xD;
        Exclusion Criteria: None&#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>Jean-Christophe BERNHARD, PHU</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCL Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69002</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Diaconesses</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU La Pitié Salpétrière/ Kremlin Bicêtre</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Saint Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Henri MONDOR</name>
      <address>
        <city>Paris</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes - Centre Eugène Marquis</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse - Centre Claudius Régaud</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Tours</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 12, 2016</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urology</keyword>
  <keyword>Robotic surgery</keyword>
  <keyword>Haemostasis</keyword>
  <keyword>Partial Nephrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03292549
org study id: CHUBX 2012/30
nct id: NCT03292549
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to set up the larger prospective study on robotic partial
      nephrectomy, to describe the characteristics of patients operated for kidney cancer by this
      surgical procedure and also to determine the modalities of hemostasis in this procedure.
The primary objective of the study is to describe the characteristics of patients operated
      for kidney cancer by a robotic partial nephrectomy in France (recruiting centers, patient
      profile, tumor characteristics).

      Secondary Objective(s):

        1. To describe the surgical techniques and operative development.

        2. To assess the modalities of haemostasis, during robotic partial nephrectomy.

        3. To assess peri-operative morbidity in robotic partial nephrectomy and post-operative
           complications.

        4. To assess the outcome of renal function after a robotic partial nephrectomy. This study
           is a national, multicenter, prospective, cohort.
observational model: Cohort
time perspective: Prospective
measure: Post-operative complications evaluated according to the Clavien criteria
time frame: From surgery until 1 year of follow up
description: Per and post-operative transfusion rates
measure: Post-operative complications evaluated according to the Clavien criteria
time frame: From surgery until 1 year of follow up
description: Medical or surgical complication rates
measure: Post-operative complications evaluated according to the Clavien criteria
time frame: From surgery until 1 year of follow up
description: Clavien's grading
measure: Post-operative complications evaluated according to the Clavien criteria
time frame: From surgery until 1 year of follow up
description: Urinary fistula rate
measure: Post-operative complications evaluated according to the Clavien criteria
time frame: From surgery until 1 year of follow up
description: Necessity for nephrectomy or re-exploration
measure: Post-operative complications evaluated according to the Clavien criteria
time frame: From surgery until 1 year of follow up
description: Length of hospital stay
measure: Renal function after robotic partial nephrectomy measured by biological parameters
time frame: Follow-up during 12 months
description: Creatininemia
measure: Renal function after robotic partial nephrectomy measured by biological parameters
time frame: Follow-up during 12 months
description: MDRD GFR
measure: Per-operative modalities of haemostasis procedure
time frame: At Surgery
description: Haemostasis procedure
measure: Per-operative modalities of haemostatic agent
time frame: At Surgery
description: Haemostatic agent
arm group label: Patients
description: Robotic partial surgery
intervention type: Procedure
intervention name: Robotic partial surgery
description: Robotic partial surgery
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Christophe BERNHARD, PHU
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Kidney Neoplasms
sharing ipd: No