<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/NCT03787823</url>
  </required_header>
  <id_info>
    <org_study_id>Transdouglas RCT-Study</org_study_id>
    <nct_id>NCT03787823</nct_id>
  </id_info>
  <brief_title>RCT-evaluation of Retzius-sparing Robotic Prostatectomy</brief_title>
  <official_title>Robotic Retzius-sparing Radical Prostatectomy- a Randomized Controlled Trial Evaluating Transdouglas-RARP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heidelberg University</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>
      Prospective randomized blinded RCT comparing Transdouglas Prostatectomy to classical&#xD;
      transperitoneal anterior radical prostatectomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will evaluate functional urinary and sexual recovery, oncologic outcomes and postoperative&#xD;
      complications in patients over a follow up period of 12 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 27, 2018</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary continence</measure>
    <time_frame>1 Week after Prostatectomy</time_frame>
    <description>Pad use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resection margine</measure>
    <time_frame>pathology report, approximately 1 week postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary continence</measure>
    <time_frame>3, 6 and 12 months after Prostatectomy</time_frame>
    <description>Pad use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>First 12 months after Prostatectomy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative PSA</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">186</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Retzius-sparing RARP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>anterior transperitoneal RARP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>robotic Prostatectomy (RARP)</intervention_name>
    <description>Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP</description>
    <arm_group_label>Retzius-sparing RARP</arm_group_label>
    <arm_group_label>anterior transperitoneal RARP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for radical prostatectomy&#xD;
&#xD;
          -  &gt;18 years old&#xD;
&#xD;
          -  Literate&#xD;
&#xD;
          -  Preoperatively continent&#xD;
&#xD;
          -  informed signed consent for study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cT4-Cancer&#xD;
&#xD;
          -  Withdrawl of consent to study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heidelberg University</investigator_affiliation>
    <investigator_full_name>Joanne N. Nyarangi-Dix, M.D.</investigator_full_name>
    <investigator_title>Chief senior physician and Vice chairlady of the Dept. of Urology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>So far, no sharing planed</ipd_description>
  </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/NCT03787823
org study id: Transdouglas RCT-Study
nct id: NCT03787823
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective randomized blinded RCT comparing Transdouglas Prostatectomy to classical
      transperitoneal anterior radical prostatectomy
We will evaluate functional urinary and sexual recovery, oncologic outcomes and postoperative
      complications in patients over a follow up period of 12 months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Urinary continence
time frame: 1 Week after Prostatectomy
description: Pad use
measure: Resection margine
time frame: pathology report, approximately 1 week postoperatively
measure: Urinary continence
time frame: 3, 6 and 12 months after Prostatectomy
description: Pad use
measure: Postoperative complications
time frame: First 12 months after Prostatectomy
measure: postoperative PSA
time frame: 12 months
arm group label: Retzius-sparing RARP
arm group type: Other
description: Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP
arm group label: anterior transperitoneal RARP
arm group type: Other
description: Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP
intervention type: Procedure
intervention name: robotic Prostatectomy (RARP)
description: Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP
arm group label: Retzius-sparing RARP
arm group label: anterior transperitoneal RARP
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heidelberg University
investigator full name: Joanne N. Nyarangi-Dix, M.D.
investigator title: Chief senior physician and Vice chairlady of the Dept. of Urology
mesh term: Urinary Incontinence
sharing ipd: Undecided
ipd description: So far, no sharing planed