<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/NCT04457882</url>
  </required_header>
  <id_info>
    <org_study_id>PD2020-001</org_study_id>
    <nct_id>NCT04457882</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube</brief_title>
  <official_title>Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube: a Singlecentre, Randomised Controlled, and Non-inferiority Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai East Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai East Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized controlled and non-inferiority trial in comparison of intraperitoneal&#xD;
      laparoscopic radical prostatectomy without drainage tube between intraperitoneal laparoscopic&#xD;
      radical prostatectomy with drainage tube in the safety in men with a localized prostate&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a prospective, single-centre, randomized controlled, and non-inferiority study&#xD;
      in which all men with localized prostate cancer. This study aims to determine whether&#xD;
      intraperitoneal laparoscopic radical prostatectomy without drainage tube is non-inferior to&#xD;
      intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men&#xD;
      with a localized prostate cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 1, 2023</start_date>
  <completion_date type="Anticipated">October 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2024</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of adverse event</measure>
    <time_frame>3 month</time_frame>
    <description>Any adverse event according to the Clavien-Dindo classification will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>3 Months</time_frame>
    <description>The difference between postoperative hemoglobin and preoperative hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical recovery</measure>
    <time_frame>3 Months</time_frame>
    <description>The time between the patient's first time out of bed and the end of the surgical procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal function recovery</measure>
    <time_frame>3 Months</time_frame>
    <description>The first time to eat after the operation, the first time to exit gas after the operation,the first time to defecation after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal effusion and cyst</measure>
    <time_frame>3 Months</time_frame>
    <description>The ultrasound and CT to detect if there is abdominal effusion and cyst</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Without Drainage Tube</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>With Drainage Tube</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube</intervention_name>
    <description>No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy</description>
    <arm_group_label>Without Drainage Tube</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube</intervention_name>
    <description>Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy</description>
    <arm_group_label>With Drainage Tube</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age: more than 18 years old, less than 85 years old;&#xD;
&#xD;
          2. Patient who pathologically diagnosed with prostate cancer and plan to undergo radical&#xD;
             laparoscopic surgery for prostate cancer;&#xD;
&#xD;
          3. fully understand the clinical trial protocol and sign the informed consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients with surgical contraindications who cannot accept surgery;&#xD;
&#xD;
          2. patients with non-laparoscopic radical resection of prostate cancer;&#xD;
&#xD;
          3. patients with previous pelvic radiation therapy and complicated abdominal surgery;&#xD;
&#xD;
          4. patients judged by the investigator to be unsuitable to participate in the clinical&#xD;
             trial;&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haifeng Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai East Hospital,Tongji University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Biming He</last_name>
    <phone>+8615502139410</phone>
    <email>190589109@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Haifeng Wang</last_name>
    <phone>+8613681750891</phone>
    <email>446720864@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai East Hospital, Tongji University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Laparoscopic Radical Prostatectomy</keyword>
  <keyword>Intraperitoneal</keyword>
  <keyword>Drainage Tube</keyword>
  <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>


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/NCT04457882
org study id: PD2020-001
nct id: NCT04457882
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled and non-inferiority trial in comparison of intraperitoneal
      laparoscopic radical prostatectomy without drainage tube between intraperitoneal laparoscopic
      radical prostatectomy with drainage tube in the safety in men with a localized prostate
      cancer.
This trial is a prospective, single-centre, randomized controlled, and non-inferiority study
      in which all men with localized prostate cancer. This study aims to determine whether
      intraperitoneal laparoscopic radical prostatectomy without drainage tube is non-inferior to
      intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men
      with a localized prostate cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The rate of adverse event
time frame: 3 month
description: Any adverse event according to the Clavien-Dindo classification will be recorded
measure: Hemoglobin
time frame: 3 Months
description: The difference between postoperative hemoglobin and preoperative hemoglobin
measure: Physical recovery
time frame: 3 Months
description: The time between the patient's first time out of bed and the end of the surgical procedure
measure: Intestinal function recovery
time frame: 3 Months
description: The first time to eat after the operation, the first time to exit gas after the operation,the first time to defecation after the operation
measure: Abdominal effusion and cyst
time frame: 3 Months
description: The ultrasound and CT to detect if there is abdominal effusion and cyst
arm group label: Without Drainage Tube
arm group type: Experimental
description: No place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy
arm group label: With Drainage Tube
arm group type: Active Comparator
description: Place the drainage tube after the intraperitoneal laparoscopic radical prostatectomy
intervention type: Behavioral
intervention name: Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube
description: No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy
arm group label: Without Drainage Tube
intervention type: Behavioral
intervention name: Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube
description: Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy
arm group label: With Drainage Tube
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Haifeng Wang
role: Principal Investigator
affiliation: Shanghai East Hospital,Tongji University School of Medicine
last name: Biming He
phone: +8615502139410
email: 190589109@qq.com
last name: Haifeng Wang
phone: +8613681750891
email: 446720864@qq.com
facility: 
country: China
responsible party type: Sponsor
mesh term: Prostatic Neoplasms