<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/NCT03822234</url>
  </required_header>
  <id_info>
    <org_study_id>B2018-104-01</org_study_id>
    <nct_id>NCT03822234</nct_id>
  </id_info>
  <brief_title>A Clinical Trial of Extraperitonealization for Prevention of Parastomal Hernia After Ileal Conduit</brief_title>
  <official_title>A Prospective Multicenter Randomized Controlled Clinical Trial of Extraperitonealization for Prevention of Parastomal Hernia After Ileal Conduit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</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>
      Many complications may occur after ileal conduit, with the incidence increasing with time&#xD;
      after surgery. Nearly half of the complications are related to stoma and ureteroileal&#xD;
      anastomosis. The investigators believe that the surgical technique is responsible for these&#xD;
      complications, and therefore have devised a modified technique for creating the ileal conduit&#xD;
      that should help prevent these complications after surgery. The investigators' retrospective&#xD;
      study shows that modified surgical technique for ileal conduit urinary diversion appears to&#xD;
      be effective for reducing early and late complications related to the stoma. Thus the&#xD;
      investigators would like to perform a prospective multicenter randomized controlled clinical&#xD;
      study to prove the investigators' results.&#xD;
&#xD;
      The investigators plan to enroll 104 patients, and randomizedly divide the participants into&#xD;
      two groups, with one group 52 patients undergoing conventional ileal conduit, another group&#xD;
      52 patients undergoing modified ileal conduit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ileal conduit (Bricker) has been used for urinary diversion for more than half a century.&#xD;
      Widely accepted to be a simple and safe form of urinary diversion, it remains one of the most&#xD;
      commonly used techniques for urinary diversion after radical cystectomy for bladder cancer.&#xD;
      However, many complications may occur after ileal conduit, with the incidence increasing with&#xD;
      time after surgery. Interestingly, nearly half of the complications are related to stoma and&#xD;
      ureteroileal anastomosis. Among the complications, parastomal hernia is the most common.&#xD;
      Female gender, low preoperative serum albumin level, high BMI or severe obesity, and prior&#xD;
      laparotomy have been shown to be risk factors for parastomal hernia. But the mechanisms by&#xD;
      which these variables lead to stoma related complications have not yet been fully elucidated.&#xD;
      The investigators believe that the surgical technique is responsible for these complications,&#xD;
      and therefore have devised a modified technique for creating the ileal conduit that should&#xD;
      help prevent these complications after surgery. The investigators' retrospective study shows&#xD;
      that modified surgical technique for ileal conduit urinary diversion appears to be effective&#xD;
      for reducing early and late complications related to the stoma. Thus the investigators would&#xD;
      like to perform a prospective multicenter randomized controlled clinical study to prove the&#xD;
      investigators' results.&#xD;
&#xD;
      The investigators plan to enroll 104 patients, and randomizedly divide the participants into&#xD;
      two groups, with one group 52 patients undergoing conventional ileal conduit, another group&#xD;
      52 patients undergoing modified ileal conduit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of parastomal hernia in 2 years</measure>
    <time_frame>2 years</time_frame>
    <description>Incidence of parastomal hernia in 2 years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of stomal retraction in 2 years</measure>
    <time_frame>2 years</time_frame>
    <description>Incidence of stomal retraction in 2 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of stomal stenosis in 2 years</measure>
    <time_frame>2 years</time_frame>
    <description>Incidence of stomal stenosis in 2 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of stomal prolapse in 2 years</measure>
    <time_frame>2 years</time_frame>
    <description>Incidence of stomal prolapse in 2 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>up to 2 years. From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 24 months</time_frame>
    <description>Overall Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-Free Survival</measure>
    <time_frame>up to 2 years. From date of randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 24 months</time_frame>
    <description>Disease-Free Survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Modified ileal conduit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With our modified ileal conduit technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional ileal conduit</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conventional ileal conduit</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Modified ileal conduit</intervention_name>
    <description>Modified ileal conduit (Extraperitonealization)</description>
    <arm_group_label>Modified ileal conduit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-75 years old, gender not limited, life expectancy is greater than or equal to&#xD;
             24 months；&#xD;
&#xD;
          2. ECOG score of patients: 0-1；&#xD;
&#xD;
          3. Volunteer to participate in this study and sign the informed consent；&#xD;
&#xD;
          4. T2-T4a, N0-x,M0 invasive bladder cancer; High risk non-muscular invasive bladder&#xD;
             cancer T1G3(high grade) tumor; Tis in which BCG therapy failed; Recurrent non-invasive&#xD;
             bladder cancer; TUR and bladder perfusion were used for treatment of uncontrolled&#xD;
             extensive papillary lesions and bladder non-urothelial carcinoma;&#xD;
&#xD;
          5. Major organ functions, such as liver, kidney, bone marrow, heart and other important&#xD;
             organs, were not significantly abnormal: AST, ALT≤2.5 upper limit of normal value&#xD;
             (ULN); Total bilirubin (TBIL)≤1.5 ULN; Albumin (ALB)≥25g/L; Serum creatinine (CRE)≤1.5&#xD;
             ULN; Leukocytes≥3.5*109/L, neutrophils≥1.5*109/L, hemoglobin≥90g/L,&#xD;
             platelets≥80*109/L; Left ventricular ejection fraction (LVEF) ≥50%; Electrocardiogram&#xD;
             showed no obvious abnormality or no clinical significance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A history of major middle and lower abdominal surgery;&#xD;
&#xD;
          2. Obese patients （BMI≥40kg/m2）;&#xD;
&#xD;
          3. Failure to receive regular follow-up review as required;&#xD;
&#xD;
          4. Severe cardiovascular disease;&#xD;
&#xD;
          5. History of immunodeficiency and organ transplantation；&#xD;
&#xD;
          6. History of severe central nervous system disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cancer Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fang-Jian Zhou, M.D Ph.D</last_name>
      <phone>+8613922735659</phone>
      <email>zhoufj@sysucc.org.cn</email>
    </contact>
    <contact_backup>
      <last_name>Zhi-Ling Zhang, M.D Ph.D</last_name>
      <phone>+8613929527746</phone>
      <email>zhangzhl@sysucc.org.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Fang-Jian Zhou, M.D Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zhi-Ling Zhang, M.D Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zhi-Yong Li, M.D Ph.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>ZHOU FANGJIAN</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder 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/NCT03822234
org study id: B2018-104-01
nct id: NCT03822234
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Many complications may occur after ileal conduit, with the incidence increasing with time
      after surgery. Nearly half of the complications are related to stoma and ureteroileal
      anastomosis. The investigators believe that the surgical technique is responsible for these
      complications, and therefore have devised a modified technique for creating the ileal conduit
      that should help prevent these complications after surgery. The investigators' retrospective
      study shows that modified surgical technique for ileal conduit urinary diversion appears to
      be effective for reducing early and late complications related to the stoma. Thus the
      investigators would like to perform a prospective multicenter randomized controlled clinical
      study to prove the investigators' results.

      The investigators plan to enroll 104 patients, and randomizedly divide the participants into
      two groups, with one group 52 patients undergoing conventional ileal conduit, another group
      52 patients undergoing modified ileal conduit.
The ileal conduit (Bricker) has been used for urinary diversion for more than half a century.
      Widely accepted to be a simple and safe form of urinary diversion, it remains one of the most
      commonly used techniques for urinary diversion after radical cystectomy for bladder cancer.
      However, many complications may occur after ileal conduit, with the incidence increasing with
      time after surgery. Interestingly, nearly half of the complications are related to stoma and
      ureteroileal anastomosis. Among the complications, parastomal hernia is the most common.
      Female gender, low preoperative serum albumin level, high BMI or severe obesity, and prior
      laparotomy have been shown to be risk factors for parastomal hernia. But the mechanisms by
      which these variables lead to stoma related complications have not yet been fully elucidated.
      The investigators believe that the surgical technique is responsible for these complications,
      and therefore have devised a modified technique for creating the ileal conduit that should
      help prevent these complications after surgery. The investigators' retrospective study shows
      that modified surgical technique for ileal conduit urinary diversion appears to be effective
      for reducing early and late complications related to the stoma. Thus the investigators would
      like to perform a prospective multicenter randomized controlled clinical study to prove the
      investigators' results.

      The investigators plan to enroll 104 patients, and randomizedly divide the participants into
      two groups, with one group 52 patients undergoing conventional ileal conduit, another group
      52 patients undergoing modified ileal conduit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of parastomal hernia in 2 years
time frame: 2 years
description: Incidence of parastomal hernia in 2 years
measure: Incidence of stomal retraction in 2 years
time frame: 2 years
description: Incidence of stomal retraction in 2 years
measure: Incidence of stomal stenosis in 2 years
time frame: 2 years
description: Incidence of stomal stenosis in 2 years
measure: Incidence of stomal prolapse in 2 years
time frame: 2 years
description: Incidence of stomal prolapse in 2 years
measure: Overall Survival
time frame: up to 2 years. From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 24 months
description: Overall Survival
measure: Disease-Free Survival
time frame: up to 2 years. From date of randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 24 months
description: Disease-Free Survival
arm group label: Modified ileal conduit
arm group type: Experimental
description: With our modified ileal conduit technique
arm group label: Conventional ileal conduit
arm group type: No Intervention
description: Conventional ileal conduit
intervention type: Procedure
intervention name: Modified ileal conduit
description: Modified ileal conduit (Extraperitonealization)
arm group label: Modified ileal conduit
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: ZHOU FANGJIAN
investigator title: Director
mesh term: Urinary Bladder Neoplasms
sharing ipd: No