<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/NCT03280459</url>
  </required_header>
  <id_info>
    <org_study_id>2017-01260</org_study_id>
    <nct_id>NCT03280459</nct_id>
  </id_info>
  <brief_title>Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction</brief_title>
  <acronym>iRARC-KSW</acronym>
  <official_title>Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kantonsspital Winterthur KSW</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Winterthur KSW</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>
      Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with&#xD;
      intracorporeal reconstruction of urinary diversion. Patient Data is entered in an anonymized&#xD;
      registry for analyzation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The registry includes patients after robot-assisted cystectomy, mainly as therapy for muscle&#xD;
      invasive urothelial carcinoma. The urinary diversion will be completed intracorporeal either&#xD;
      as ileal conduit or ileal neobladder. Outcome parameters include perioperative complications,&#xD;
      oncologic data and oncologic follow-up data (tumor classification, recurrence, survival) as&#xD;
      well as data on functional follow up (continence, quality of life).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>postoperative complications</measure>
    <time_frame>1 year</time_frame>
    <description>deviations from normal postoperative course [&quot;Clavien-Dindo&quot; Grade]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment of tumor recurrence</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life urology specific</measure>
    <time_frame>1 year</time_frame>
    <description>EORTC-BLM 30 (European Organisation for Research and Treatment of Cancer Questionaire for muscle invasive bladder cancer) questionaire for evaluation of quality of life for patients with muscle invasive bladder cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life overall</measure>
    <time_frame>1 year</time_frame>
    <description>EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire) questionaire for evaluation of quality of life for oncologic patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operation Time</measure>
    <time_frame>expected 4-8 hours</time_frame>
    <description>duration of operation [min]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Death by any cause</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>Death by any cause [n/months]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pouch capacity</measure>
    <time_frame>1 year</time_frame>
    <description>interventional measurement of pouch capacity with pressure recording catheter [ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of tumor-recurrence</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>Location of tumor recurrence (local, metastasis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>expected 4-8 hours</time_frame>
    <description>blood loss during operation [ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>time until recurrence of tumor [months]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor specific death</measure>
    <time_frame>through study completion, an average of 5 years</time_frame>
    <description>Time to tumor specific death [months]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative Tumor staging</measure>
    <time_frame>90 days</time_frame>
    <description>Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Tumor staging</measure>
    <time_frame>90 days</time_frame>
    <description>Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pouch-pressure</measure>
    <time_frame>1 year</time_frame>
    <description>interventional measurement of pouch-pressure [cmH2O]with pressure recording catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postvoid residual urine</measure>
    <time_frame>1 year</time_frame>
    <description>Residual urin after voiding [ml]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional length of urethral sphincter</measure>
    <time_frame>1 year</time_frame>
    <description>interventional measurement of Functional length of urethral sphincter [mm] with pressure recording catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional pressure of urethral sphincter</measure>
    <time_frame>1 year</time_frame>
    <description>interventional measurement of functional pressure of urethral sphincter [cmH2O] with pressure recording catheter</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Urothelial Carcinoma</condition>
  <condition>Cystectomy</condition>
  <condition>Urinary Diversion</condition>
  <condition>Complication of Surgical Procedure</condition>
  <condition>Complication, Postoperative</condition>
  <condition>Neobladder</condition>
  <condition>Ileal Conduit</condition>
  <condition>Robotic Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>Ileal Conduit</arm_group_label>
    <description>Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neobladder</arm_group_label>
    <description>Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>robot-assisted cystectomy</intervention_name>
    <description>Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy</description>
    <arm_group_label>Ileal Conduit</arm_group_label>
    <arm_group_label>Neobladder</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Onkologic patients that qualify for radical cystectomy according to institutional&#xD;
        tumor-board decision or patients with functional indications after failure of all other&#xD;
        therapy modalities and receive a cystectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 years&#xD;
&#xD;
          -  informed consent for operation and data use&#xD;
&#xD;
          -  Oncologic patients that qualify for radical cystectomy according to institutional&#xD;
             tumor-board decision or patients with functional indications after failure of all&#xD;
             other therapy modalities and receive a cystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  declined informed consent / data use&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Christoph Schregel, MD</last_name>
    <email>christophschregel@gmx.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Orlando Burkhardt, MD</last_name>
    <phone>+41792912821</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kantonsspital Winterthur</name>
      <address>
        <city>Winterthur</city>
        <zip>8401</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christoph Schregel, M.D.</last_name>
      <phone>+4152264331</phone>
      <phone_ext>+14766737873</phone_ext>
      <email>christophschregel@gmx.de</email>
    </contact>
    <contact_backup>
      <last_name>Hubert John, M.D.</last_name>
      <phone>+41522662982</phone>
      <email>hubert.john@ksw.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kantonsspital Winterthur KSW</investigator_affiliation>
    <investigator_full_name>Christoph Schregel</investigator_full_name>
    <investigator_title>Assistenzarzt Urologie / resident Departement of Urology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>depersonalized Data may be shared with other academic centers if data security and ethical considerations equal to swiss standards are followed</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/NCT03280459
org study id: 2017-01260
nct id: NCT03280459
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with
      intracorporeal reconstruction of urinary diversion. Patient Data is entered in an anonymized
      registry for analyzation.
The registry includes patients after robot-assisted cystectomy, mainly as therapy for muscle
      invasive urothelial carcinoma. The urinary diversion will be completed intracorporeal either
      as ileal conduit or ileal neobladder. Outcome parameters include perioperative complications,
      oncologic data and oncologic follow-up data (tumor classification, recurrence, survival) as
      well as data on functional follow up (continence, quality of life).
observational model: Cohort
time perspective: Prospective
measure: postoperative complications
time frame: 1 year
description: deviations from normal postoperative course ["Clavien-Dindo" Grade]
measure: Treatment of tumor recurrence
time frame: through study completion, an average of 5 years
description: Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)
measure: Quality of Life urology specific
time frame: 1 year
description: EORTC-BLM 30 (European Organisation for Research and Treatment of Cancer Questionaire for muscle invasive bladder cancer) questionaire for evaluation of quality of life for patients with muscle invasive bladder cancer
measure: Quality of Life overall
time frame: 1 year
description: EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire) questionaire for evaluation of quality of life for oncologic patients
measure: Operation Time
time frame: expected 4-8 hours
description: duration of operation [min]
measure: Postoperative Death by any cause
time frame: through study completion, an average of 5 years
description: Death by any cause [n/months]
measure: Pouch capacity
time frame: 1 year
description: interventional measurement of pouch capacity with pressure recording catheter [ml]
measure: Type of tumor-recurrence
time frame: through study completion, an average of 5 years
description: Location of tumor recurrence (local, metastasis)
measure: Blood loss
time frame: expected 4-8 hours
description: blood loss during operation [ml]
measure: Time to recurrence
time frame: through study completion, an average of 5 years
description: time until recurrence of tumor [months]
measure: Tumor specific death
time frame: through study completion, an average of 5 years
description: Time to tumor specific death [months]
measure: Preoperative Tumor staging
time frame: 90 days
description: Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
measure: Postoperative Tumor staging
time frame: 90 days
description: Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
measure: Pouch-pressure
time frame: 1 year
description: interventional measurement of pouch-pressure [cmH2O]with pressure recording catheter
measure: Postvoid residual urine
time frame: 1 year
description: Residual urin after voiding [ml]
measure: Functional length of urethral sphincter
time frame: 1 year
description: interventional measurement of Functional length of urethral sphincter [mm] with pressure recording catheter
measure: Functional pressure of urethral sphincter
time frame: 1 year
description: interventional measurement of functional pressure of urethral sphincter [cmH2O] with pressure recording catheter
arm group label: Ileal Conduit
description: Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy
arm group label: Neobladder
description: Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy
intervention type: Procedure
intervention name: robot-assisted cystectomy
description: Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy
arm group label: Ileal Conduit
arm group label: Neobladder
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christoph Schregel, MD
email: christophschregel@gmx.de
last name: Orlando Burkhardt, MD
phone: +41792912821
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Kantonsspital Winterthur KSW
investigator full name: Christoph Schregel
investigator title: Assistenzarzt Urologie / resident Departement of Urology
mesh term: Postoperative Complications
sharing ipd: Undecided
ipd description: depersonalized Data may be shared with other academic centers if data security and ethical considerations equal to swiss standards are followed