<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/NCT03241758</url>
  </required_header>
  <id_info>
    <org_study_id>RadicalDoppler</org_study_id>
    <nct_id>NCT03241758</nct_id>
  </id_info>
  <brief_title>Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy</brief_title>
  <official_title>Valuation Of Vascular Changes And Their Impact On Erectile Function By Penile Doppler Ultrasound And Analysis Of The Quality Of Life Of Patients Undergoing Laparoscopic Radical Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</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>
      A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using&#xD;
      Doppler ultrasound and the impact of such changes on erectile function and quality of life of&#xD;
      patients. The baseline study will be compared with the study one year after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2011</start_date>
  <completion_date type="Actual">August 2, 2017</completion_date>
  <primary_completion_date type="Actual">August 2, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Left and right Cavernous artery diameter</measure>
    <time_frame>1 year</time_frame>
    <description>mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Left and right Systolic velocity cavernous artery</measure>
    <time_frame>1 year</time_frame>
    <description>cm/s</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Left and right Diastolyc velocity cavernous artery</measure>
    <time_frame>1 year</time_frame>
    <description>cm/s</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">110</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <condition>Erectile Dysfunction Following Radical Prostatectomy</condition>
  <arm_group>
    <arm_group_label>Group #1</arm_group_label>
    <description>Patients with prostate cancer who will undergo radical prostatectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Doppler ultrasound</intervention_name>
    <description>Basal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy</description>
    <arm_group_label>Group #1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male patients with prostate cancer who underwent laparoscopic radical prostatectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patients with prostate cancer who underwent laparoscopic radical prostatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were not interested in their sexual function and refused to perform this&#xD;
             study&#xD;
&#xD;
          -  Patients who required adjuvant or salvage treatment for their prostate cancer&#xD;
             (radiation therapy, chemotherapy or androgen deprivation therapy) during follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jesus Muñoz-Rodriguez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporació Sanitaria Parc Tauli</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Jesus Muñoz-Rodriguez</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Erectile Dysfunction</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/NCT03241758
org study id: RadicalDoppler
nct id: NCT03241758
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using
      Doppler ultrasound and the impact of such changes on erectile function and quality of life of
      patients. The baseline study will be compared with the study one year after surgery.
observational model: Case-Crossover
time perspective: Prospective
measure: Left and right Cavernous artery diameter
time frame: 1 year
description: mm
measure: Left and right Systolic velocity cavernous artery
time frame: 1 year
description: cm/s
measure: Left and right Diastolyc velocity cavernous artery
time frame: 1 year
description: cm/s
arm group label: Group #1
description: Patients with prostate cancer who will undergo radical prostatectomy
intervention type: Diagnostic Test
intervention name: Doppler ultrasound
description: Basal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy
arm group label: Group #1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jesus Muñoz-Rodriguez, MD
role: Principal Investigator
affiliation: Corporació Sanitaria Parc Tauli
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Jesus Muñoz-Rodriguez
investigator title: Medical Doctor
mesh term: Prostatic Neoplasms
mesh term: Erectile Dysfunction
sharing ipd: No