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/NCT06020287</url>
    </required_header>
    <id_info>
      <org_study_id>NanjingUSM202388</org_study_id>
      <nct_id>NCT06020287</nct_id>
    </id_info>
    <brief_title>The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach</brief_title>
    <official_title>The Early Therapeutic Efficacy of The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach: A Single-Center Retrospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanjing University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanjing University School of Medicine</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 goal of this observational study was to compare the perioperative outcomes, postoperative&#xD;
        urinary control rates and positive surgical margin (PSM) rates of the robot-assisted&#xD;
        laparoscopic radical prostatectomy combined anterior and posterior approach (AP-RARP) with&#xD;
        the Retzius-sparing approach (RS-RARP) and anterior approach (anterior-RARP) in the treatment&#xD;
        of prostate cancer. The main question it aims to answer was:&#xD;
  &#xD;
        • The early therapeutic efficacy of the robot-assisted laparoscopic radical prostatectomy&#xD;
        combined anterior and posterior approach&#xD;
  &#xD;
        Participants has been underwent:&#xD;
  &#xD;
          -  AP-RARP&#xD;
  &#xD;
          -  RS-RARP&#xD;
  &#xD;
          -  anterior-RARP Researchers compared the three groups to see if AP-RARP combines the&#xD;
             advantages of anterior and posterior RARP and is a feasible surgical option for the&#xD;
             treatment of prostate cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2020</start_date>
    <completion_date type="Actual">December 27, 2022</completion_date>
    <primary_completion_date type="Actual">May 31, 2022</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>urinary continence</measure>
      <time_frame>0-6 month after surgery</time_frame>
      <description>was defined as using 0-1 pad a day</description>
    </primary_outcome>
    <primary_outcome>
      <measure>positive surgical margin</measure>
      <time_frame>2 weeks after surgery</time_frame>
      <description>observed whether the tissue cutting in surgery has tumor cell in surgical margin by pathologist</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>operating time</measure>
      <time_frame>the day of the surgery</time_frame>
      <description>The start time of the operation refers to the time of incision of the skin at the surgical site. The end time of surgery refers to the time when the skin is sutured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>intraoperative blood loss</measure>
      <time_frame>the day of the surgery</time_frame>
      <description>Intraoperative bleeding was defined as the sum of blood content in blood gauze, blood content in negative pressure suction bottle and blood clot volume.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">233</enrollment>
    <condition>Prostatectomy</condition>
    <condition>Prostate Neoplasm</condition>
    <arm_group>
      <arm_group_label>AP-RARP</arm_group_label>
      <description>the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RS-RARP</arm_group_label>
      <description>the robot-assisted laparoscopic radical prostatectomy with the Retzius-sparing approach</description>
    </arm_group>
    <arm_group>
      <arm_group_label>anterior-RARP</arm_group_label>
      <description>he robot-assisted laparoscopic radical prostatectomy with anterior approach</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>the robot-assisted laparoscopic radical prostatectomy</intervention_name>
      <description>We collect medical data of 233 patients with clinically localized prostate cancer who underwent AP-RARP, RS-RARP or anterior-RARP. Perioperative outcomes, including operation time, intraoperative blood loss, intraoperative and postoperative transfusion, postoperative infection, and anastomotic leakage, were compared among the three groups. The postoperative continence rates and PSM rates were also compared.</description>
      <arm_group_label>AP-RARP</arm_group_label>
      <arm_group_label>RS-RARP</arm_group_label>
      <arm_group_label>anterior-RARP</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The clinical data of 233 patients treated between September 2020 and May 2022 at Nanjing&#xD;
          Drum Tower Hospital were retrospectively analyzed.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  pathologically diagnosed with prostate cancer by prostate biopsy&#xD;
  &#xD;
            -  underwent robot-assisted laparoscopic surgery&#xD;
  &#xD;
            -  the surgery performed by Weidong Gan&#xD;
  &#xD;
            -  the extended pelvic lymphadenectomy (PLA) is performed on patients with high-risk&#xD;
               prostate cancer (PSA≥20 ng/ml or Grade Group 4-5 or clinical stage ≥T2c) and those&#xD;
               considered to have a possibility of lymph node metastasis based on imaging evaluation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a clinical and pathological TNM stage ≥T3b and N1&#xD;
  &#xD;
            -  patients with distant metastasis&#xD;
  &#xD;
            -  urinary incontinence before surgery&#xD;
  &#xD;
            -  received neoadjuvant therapy before surgery&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210008</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Nanjing University School of Medicine</investigator_affiliation>
      <investigator_full_name>Fan Feng</investigator_full_name>
      <investigator_title>Attending Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06020287
  org study id: NanjingUSM202388
  nct id: NCT06020287
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study was to compare the perioperative outcomes, postoperative
        urinary control rates and positive surgical margin (PSM) rates of the robot-assisted
        laparoscopic radical prostatectomy combined anterior and posterior approach (AP-RARP) with
        the Retzius-sparing approach (RS-RARP) and anterior approach (anterior-RARP) in the treatment
        of prostate cancer. The main question it aims to answer was:
  
        • The early therapeutic efficacy of the robot-assisted laparoscopic radical prostatectomy
        combined anterior and posterior approach
  
        Participants has been underwent:
  
          -  AP-RARP
  
          -  RS-RARP
  
          -  anterior-RARP Researchers compared the three groups to see if AP-RARP combines the
             advantages of anterior and posterior RARP and is a feasible surgical option for the
             treatment of prostate cancer.
  observational model: Cohort
  time perspective: Retrospective
  measure: urinary continence
  time frame: 0-6 month after surgery
  description: was defined as using 0-1 pad a day
  measure: positive surgical margin
  time frame: 2 weeks after surgery
  description: observed whether the tissue cutting in surgery has tumor cell in surgical margin by pathologist
  measure: operating time
  time frame: the day of the surgery
  description: The start time of the operation refers to the time of incision of the skin at the surgical site. The end time of surgery refers to the time when the skin is sutured.
  measure: intraoperative blood loss
  time frame: the day of the surgery
  description: Intraoperative bleeding was defined as the sum of blood content in blood gauze, blood content in negative pressure suction bottle and blood clot volume.
  arm group label: AP-RARP
  description: the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach
  arm group label: RS-RARP
  description: the robot-assisted laparoscopic radical prostatectomy with the Retzius-sparing approach
  arm group label: anterior-RARP
  description: he robot-assisted laparoscopic radical prostatectomy with anterior approach
  intervention type: Procedure
  intervention name: the robot-assisted laparoscopic radical prostatectomy
  description: We collect medical data of 233 patients with clinically localized prostate cancer who underwent AP-RARP, RS-RARP or anterior-RARP. Perioperative outcomes, including operation time, intraoperative blood loss, intraoperative and postoperative transfusion, postoperative infection, and anastomotic leakage, were compared among the three groups. The postoperative continence rates and PSM rates were also compared.
  arm group label: AP-RARP
  arm group label: RS-RARP
  arm group label: anterior-RARP
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Nanjing University School of Medicine
  investigator full name: Fan Feng
  investigator title: Attending Doctor
  mesh term: Prostatic Neoplasms
  sharing ipd: Undecided