<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/NCT03023488</url>
  </required_header>
  <id_info>
    <org_study_id>MAR.UAD.002</org_study_id>
    <secondary_id>09.2016.181</secondary_id>
    <nct_id>NCT03023488</nct_id>
  </id_info>
  <brief_title>Effects of Flexible Ureteroscopy on Renal Blood Flow</brief_title>
  <official_title>Effects Of Flexible Ureteroscopy On Renal Blood Flow</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this study is to investigate the effects of increased intrarenal pressure during&#xD;
      flexible ureteroscopy on renal blood flow.&#xD;
&#xD;
      Patients undergoing flexible ureteroscopy (F-URS) and laser lithotripsy for kidney stones&#xD;
      according to European Association of Urology (EAU) guidelines on Urolithiasis will be&#xD;
      included in the study after having signed an informed consent form. The pre- and&#xD;
      post-operative evaluation and management will be performed according to EAU Guidelines on&#xD;
      Urolithiasis. Additionally, as a non-invasive test, bilateral renal power Doppler US will be&#xD;
      performed to patients pre- and post-operatively. The pre-operative Doppler US will be&#xD;
      performed 2 days prior to surgery and the post-operative Doppler US will be performed in the&#xD;
      first 24 hours following surgery. The changes on blood flow in renal artery and arcuate&#xD;
      artery will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of this study is to investigate the effects of increased intrarenal pressure during&#xD;
      flexible ureteroscopy on renal blood flow.&#xD;
&#xD;
      Patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones according&#xD;
      to EAU guidelines on Urolithiasis will be included in the study after having signed an&#xD;
      informed consent form. The pre- and post-operative evaluation and management will be&#xD;
      performed according to EAU Guidelines on Urolithiasis. Additionally, as a non-invasive test,&#xD;
      bilateral renal power Doppler US will be performed to patients pre- and post-operatively. The&#xD;
      pre-operative Doppler US will be performed 2 days prior to surgery and the post-operative&#xD;
      Doppler US will be performed in the first 24 hours following surgery. The changes on blood&#xD;
      flow in renal artery and arcuate artery will be recorded.&#xD;
&#xD;
      Flexible ureteroscopy has been a key component of kidney stone management in the last 20&#xD;
      years. Even for stones larger than 2 cm, flexible ureteroscopy can be performed with high&#xD;
      success and low complication rates. Ureteral access sheaths are key contributors to flexible&#xD;
      ureteroscopy as they provide easy and repeated access to upper urinary tract and decreased&#xD;
      intrarenal pressures due to easy flow back of the irrigation solution.&#xD;
&#xD;
      The increased pressures during flexible ureteroscopy have been an important research area in&#xD;
      the last years. Due to irrigation solution and irrigational pumping to provide a clearer&#xD;
      vision during flexible ureteroscopy, intrarenal pressures rise and after a certain point&#xD;
      pyelo-sinusoidal, pyelo-venous and pyelo-lymphatic backflow starts. It has been shown that&#xD;
      this backflow starts when pressure rises above 40 cmH2O (centimeters-water / unit of pressure&#xD;
      measurement). Schwalb et al. demonstrated in their study that in kidneys subject to high&#xD;
      intrarenal pressure, denudation and flattening of the caliceal urothelium, submucosal edema&#xD;
      and congestion are observed. Due to these deleterious effects on urothelium, renal&#xD;
      extravasation and bacterial translocation can occur and complications may arise.&#xD;
&#xD;
      Renal Doppler US, due to its non-invasive nature, has been widely used to measure localized&#xD;
      blood flow in the kidneys, to evaluate hemodynamic parameters in acute kidney injury.&#xD;
      Intrarenal backflow and its consequences such as submucosal edema and congestion may decrease&#xD;
      blood flow especially around the calyces subject to high pressures and this situation may&#xD;
      result in acute kidney injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</measure>
    <time_frame>The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation</time_frame>
    <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
PSV is the maximum velocity in the renal and arcuate arteries in the systolic phase of each heart pulse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End Diastolic Velocities (EDV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</measure>
    <time_frame>The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation</time_frame>
    <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
EDV is the velocity in the renal and arcuate arteries at the end of the diastolic phase of each heart pulse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resistive Index (RI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</measure>
    <time_frame>The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation</time_frame>
    <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
Resistive index is calculated as the difference between PSV and EDV, divided by PSV [(PSV - EDV) / (PSV)].&#xD;
An increased resistive index can be considered as a marker of intrarenal arterial stiffness and is associated with worsening of renal function and tubulointersitial damage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulsatility Index (PI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</measure>
    <time_frame>The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation</time_frame>
    <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
Pulsatility index is calculated as the difference between PSV and EDV, divided by the mean velocity [(PSV - EDV) / ((PSV + EDV) / 2)].&#xD;
Pulsatility index is used to discriminate between renal and pre-renal causes of acute kidney injury which can alter the therapeutic options in the clinical setting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical Details - Size of Ureteral Access Sheath</measure>
    <time_frame>1 hour after the operation</time_frame>
    <description>The size of access sheaths will be given in French measurement. E.g. 10/12 Fr</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Details - Name of Flexible Ureteroscope</measure>
    <time_frame>1 hour after the operation</time_frame>
    <description>Each ureteroscope has unique characteristics. So, every ureteroscope that will be used, will be recorded with its name. E.g. Storz Flex-X2, Olympus V1, Wolf Cobra</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of the Flexible Ureteroscopy Operation</measure>
    <time_frame>10 minutes after the operation</time_frame>
    <description>the data about the duration of the operation that will be performed for each patient and the data will be recorded in minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative Characteristics - Irrigation Pressure</measure>
    <time_frame>1 hour after the operation</time_frame>
    <description>The pressure that is applied to the irrigation solution which is circulated through the ureteroscope that is used to expand the renal cavities during a flexible ureteroscopy operation. the data will be collected in cmH2O. This pressure value is a constant value and it doesn't change throughout the length of the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative Characteristics - Intraoperative Complications</measure>
    <time_frame>1 hour after the operation</time_frame>
    <description>The number of patients that has experienced any kind of intraoperative complications during the flexible ureteroscopy operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Operative Characteristics - Complications</measure>
    <time_frame>The data will be recorded within 1 month after each procedure.</time_frame>
    <description>The number of patients that had a complication in the first 1 month after the operation according to the Clavien Dindo Grading system (0-5).&#xD;
Clavien Dindo Grading ranges from 0 (mildest) to 5 (most severe). 0. No complications&#xD;
Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside&#xD;
Complications requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included&#xD;
Complications requiring surgical, endoscopic or radiological intervention&#xD;
Life-threatening complications (including CNS complications) requiring IC/ICU management&#xD;
Death</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Circulatory; Change</condition>
  <arm_group>
    <arm_group_label>Flexible ureteroscopy arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Doppler Ultrasound examination has been performed in the pre-operative and post-operative periods</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>flexible ureteroscopy</intervention_name>
    <description>Flexible ureteroscopy is an endourological procedure performed for kidney stones. The flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During the operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and also to provide clear vision.</description>
    <arm_group_label>Flexible ureteroscopy arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Doppler Ultrasound examination</intervention_name>
    <description>peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.</description>
    <arm_group_label>Flexible ureteroscopy arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laser lithotripsy</intervention_name>
    <description>The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and transmitted to the stones via the laser fiber.</description>
    <arm_group_label>Flexible ureteroscopy arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between ages 18-65&#xD;
&#xD;
          -  Patients undergoing flexible ureteroscopy + laser lithotripsy according to EAU&#xD;
             Guidelines on Urolithiasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients with already-diagnosed urological malignancies&#xD;
&#xD;
          -  Patients ineligible for flexible ureteroscopy due to concomitant co-morbidities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tarik Emre Sener, Urologist</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marmara University, School of Medicine, Department of Urology</affiliation>
  </overall_official>
  <reference>
    <citation>Schwalb DM, Eshghi M, Davidian M, Franco I. Morphological and physiological changes in the urinary tract associated with ureteral dilation and ureteropyeloscopy: an experimental study. J Urol. 1993 Jun;149(6):1576-85. doi: 10.1016/s0022-5347(17)36456-x.</citation>
    <PMID>8501816</PMID>
  </reference>
  <reference>
    <citation>de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17.</citation>
    <PMID>24147820</PMID>
  </reference>
  <results_reference>
    <citation>Sener TE, Cloutier J, Villa L, Marson F, Buttice S, Doizi S, Traxer O. Can We Provide Low Intrarenal Pressures with Good Irrigation Flow by Decreasing the Size of Ureteral Access Sheaths? J Endourol. 2016 Jan;30(1):49-55. doi: 10.1089/end.2015.0387. Epub 2015 Sep 18. Erratum In: J Endourol. 2017 Jan;31(1):110.</citation>
    <PMID>26381037</PMID>
  </results_reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>February 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>January 18, 2017</results_first_submitted>
  <results_first_submitted_qc>May 16, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 18, 2017</results_first_posted>
  <last_update_submitted>June 6, 2018</last_update_submitted>
  <last_update_submitted_qc>June 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>flexible ureteroscopy</keyword>
  <keyword>blood flow</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Flexible Ureteroscopy Arm</title>
          <description>Doppler Ultrasound examination was performed in both the pre-operative and post-operative periods on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients undergoing F-URS and laser lithotripsy for kidney stones in accordance with the EAU guidelines on Urolithiasis</population>
      <group_list>
        <group group_id="B1">
          <title>Flexible Ureteroscopy Arm</title>
          <description>findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.24" lower_limit="17" upper_limit="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI) units: kg/m2</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.49" spread="4.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stone volume</title>
          <units>mm3</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1685" lower_limit="150" upper_limit="5868"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</title>
        <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
PSV is the maximum velocity in the renal and arcuate arteries in the systolic phase of each heart pulse.</description>
        <time_frame>The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Ureteroscopy Arm</title>
            <description>pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</title>
          <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
PSV is the maximum velocity in the renal and arcuate arteries in the systolic phase of each heart pulse.</description>
          <units>cm/s</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-operative PSV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.65" lower_limit="18" upper_limit="82.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-operative PSV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.85" lower_limit="16.5" upper_limit="84.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>End Diastolic Velocities (EDV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</title>
        <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
EDV is the velocity in the renal and arcuate arteries at the end of the diastolic phase of each heart pulse.</description>
        <time_frame>The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Ureteroscopy Arm</title>
            <description>pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
          </group>
        </group_list>
        <measure>
          <title>End Diastolic Velocities (EDV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</title>
          <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
EDV is the velocity in the renal and arcuate arteries at the end of the diastolic phase of each heart pulse.</description>
          <units>cm/s</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-operative EDV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" lower_limit="2.2" upper_limit="41.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-operative EDV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="4.4" upper_limit="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Resistive Index (RI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</title>
        <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
Resistive index is calculated as the difference between PSV and EDV, divided by PSV [(PSV - EDV) / (PSV)].&#xD;
An increased resistive index can be considered as a marker of intrarenal arterial stiffness and is associated with worsening of renal function and tubulointersitial damage.</description>
        <time_frame>The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Ureteroscopy Arm</title>
            <description>pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
          </group>
        </group_list>
        <measure>
          <title>Resistive Index (RI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</title>
          <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
Resistive index is calculated as the difference between PSV and EDV, divided by PSV [(PSV - EDV) / (PSV)].&#xD;
An increased resistive index can be considered as a marker of intrarenal arterial stiffness and is associated with worsening of renal function and tubulointersitial damage.</description>
          <units>unitless</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-operative RI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" lower_limit="0.45" upper_limit="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-operative RI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" lower_limit="0.41" upper_limit="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulsatility Index (PI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</title>
        <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
Pulsatility index is calculated as the difference between PSV and EDV, divided by the mean velocity [(PSV - EDV) / ((PSV + EDV) / 2)].&#xD;
Pulsatility index is used to discriminate between renal and pre-renal causes of acute kidney injury which can alter the therapeutic options in the clinical setting.</description>
        <time_frame>The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Ureteroscopy Arm</title>
            <description>pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
          </group>
        </group_list>
        <measure>
          <title>Pulsatility Index (PI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.</title>
          <description>Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.&#xD;
Pulsatility index is calculated as the difference between PSV and EDV, divided by the mean velocity [(PSV - EDV) / ((PSV + EDV) / 2)].&#xD;
Pulsatility index is used to discriminate between renal and pre-renal causes of acute kidney injury which can alter the therapeutic options in the clinical setting.</description>
          <units>unitless</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-operative PI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" lower_limit="0.59" upper_limit="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-operative PI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" lower_limit="0.54" upper_limit="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Technical Details - Size of Ureteral Access Sheath</title>
        <description>The size of access sheaths will be given in French measurement. E.g. 10/12 Fr</description>
        <time_frame>1 hour after the operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Ureteroscopy Arm</title>
            <description>post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
          </group>
        </group_list>
        <measure>
          <title>Technical Details - Size of Ureteral Access Sheath</title>
          <description>The size of access sheaths will be given in French measurement. E.g. 10/12 Fr</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>9.5/11.5 Fr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10/12 Fr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12/14 Fr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Technical Details - Name of Flexible Ureteroscope</title>
        <description>Each ureteroscope has unique characteristics. So, every ureteroscope that will be used, will be recorded with its name. E.g. Storz Flex-X2, Olympus V1, Wolf Cobra</description>
        <time_frame>1 hour after the operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Ureteroscopy Arm</title>
            <description>The type of the ureteroscope used for the flexible ureteroscopy operation&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
          </group>
        </group_list>
        <measure>
          <title>Technical Details - Name of Flexible Ureteroscope</title>
          <description>Each ureteroscope has unique characteristics. So, every ureteroscope that will be used, will be recorded with its name. E.g. Storz Flex-X2, Olympus V1, Wolf Cobra</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Storz Flex X2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Storz Flex XC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of the Flexible Ureteroscopy Operation</title>
        <description>the data about the duration of the operation that will be performed for each patient and the data will be recorded in minutes.</description>
        <time_frame>10 minutes after the operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Ureteroscopy Arm</title>
            <description>The duration of the flexible ureteroscopy operation&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of the Flexible Ureteroscopy Operation</title>
          <description>the data about the duration of the operation that will be performed for each patient and the data will be recorded in minutes.</description>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.2" spread="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Operative Characteristics - Irrigation Pressure</title>
        <description>The pressure that is applied to the irrigation solution which is circulated through the ureteroscope that is used to expand the renal cavities during a flexible ureteroscopy operation. the data will be collected in cmH2O. This pressure value is a constant value and it doesn't change throughout the length of the procedure.</description>
        <time_frame>1 hour after the operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Ureteroscopy Arm</title>
            <description>The pressure applied to the irrigation solution during a flexible ureteroscopy operation&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
          </group>
        </group_list>
        <measure>
          <title>Operative Characteristics - Irrigation Pressure</title>
          <description>The pressure that is applied to the irrigation solution which is circulated through the ureteroscope that is used to expand the renal cavities during a flexible ureteroscopy operation. the data will be collected in cmH2O. This pressure value is a constant value and it doesn't change throughout the length of the procedure.</description>
          <units>cmH2O</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" lower_limit="40" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Operative Characteristics - Intraoperative Complications</title>
        <description>The number of patients that has experienced any kind of intraoperative complications during the flexible ureteroscopy operation.</description>
        <time_frame>1 hour after the operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Ureteroscopy Arm</title>
            <description>The number of patients that had a complication intraoperatively.&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
          </group>
        </group_list>
        <measure>
          <title>Operative Characteristics - Intraoperative Complications</title>
          <description>The number of patients that has experienced any kind of intraoperative complications during the flexible ureteroscopy operation.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-Operative Characteristics - Complications</title>
        <description>The number of patients that had a complication in the first 1 month after the operation according to the Clavien Dindo Grading system (0-5).&#xD;
Clavien Dindo Grading ranges from 0 (mildest) to 5 (most severe). 0. No complications&#xD;
Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside&#xD;
Complications requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included&#xD;
Complications requiring surgical, endoscopic or radiological intervention&#xD;
Life-threatening complications (including CNS complications) requiring IC/ICU management&#xD;
Death</description>
        <time_frame>The data will be recorded within 1 month after each procedure.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Flexible Ureteroscopy Arm</title>
            <description>The number of patients who had a complication after the flexible ureteroscopy operation in the first month following the operation.&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
          </group>
        </group_list>
        <measure>
          <title>Post-Operative Characteristics - Complications</title>
          <description>The number of patients that had a complication in the first 1 month after the operation according to the Clavien Dindo Grading system (0-5).&#xD;
Clavien Dindo Grading ranges from 0 (mildest) to 5 (most severe). 0. No complications&#xD;
Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside&#xD;
Complications requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included&#xD;
Complications requiring surgical, endoscopic or radiological intervention&#xD;
Life-threatening complications (including CNS complications) requiring IC/ICU management&#xD;
Death</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Flexible Ureteroscopy Arm</title>
          <description>findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines&#xD;
Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.&#xD;
Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.&#xD;
laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Tarik Emre Sener</name_or_title>
      <organization>Marmara University, School of Medicine, Department of Urology</organization>
      <phone>+905337620712</phone>
      <email>dr.emresener@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03023488
org study id: MAR.UAD.002
secondary id: 09.2016.181
nct id: NCT03023488
lead sponsor: 
has dmc: No
Aim of this study is to investigate the effects of increased intrarenal pressure during
      flexible ureteroscopy on renal blood flow.

      Patients undergoing flexible ureteroscopy (F-URS) and laser lithotripsy for kidney stones
      according to European Association of Urology (EAU) guidelines on Urolithiasis will be
      included in the study after having signed an informed consent form. The pre- and
      post-operative evaluation and management will be performed according to EAU Guidelines on
      Urolithiasis. Additionally, as a non-invasive test, bilateral renal power Doppler US will be
      performed to patients pre- and post-operatively. The pre-operative Doppler US will be
      performed 2 days prior to surgery and the post-operative Doppler US will be performed in the
      first 24 hours following surgery. The changes on blood flow in renal artery and arcuate
      artery will be recorded.
Aim of this study is to investigate the effects of increased intrarenal pressure during
      flexible ureteroscopy on renal blood flow.

      Patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones according
      to EAU guidelines on Urolithiasis will be included in the study after having signed an
      informed consent form. The pre- and post-operative evaluation and management will be
      performed according to EAU Guidelines on Urolithiasis. Additionally, as a non-invasive test,
      bilateral renal power Doppler US will be performed to patients pre- and post-operatively. The
      pre-operative Doppler US will be performed 2 days prior to surgery and the post-operative
      Doppler US will be performed in the first 24 hours following surgery. The changes on blood
      flow in renal artery and arcuate artery will be recorded.

      Flexible ureteroscopy has been a key component of kidney stone management in the last 20
      years. Even for stones larger than 2 cm, flexible ureteroscopy can be performed with high
      success and low complication rates. Ureteral access sheaths are key contributors to flexible
      ureteroscopy as they provide easy and repeated access to upper urinary tract and decreased
      intrarenal pressures due to easy flow back of the irrigation solution.

      The increased pressures during flexible ureteroscopy have been an important research area in
      the last years. Due to irrigation solution and irrigational pumping to provide a clearer
      vision during flexible ureteroscopy, intrarenal pressures rise and after a certain point
      pyelo-sinusoidal, pyelo-venous and pyelo-lymphatic backflow starts. It has been shown that
      this backflow starts when pressure rises above 40 cmH2O (centimeters-water / unit of pressure
      measurement). Schwalb et al. demonstrated in their study that in kidneys subject to high
      intrarenal pressure, denudation and flattening of the caliceal urothelium, submucosal edema
      and congestion are observed. Due to these deleterious effects on urothelium, renal
      extravasation and bacterial translocation can occur and complications may arise.

      Renal Doppler US, due to its non-invasive nature, has been widely used to measure localized
      blood flow in the kidneys, to evaluate hemodynamic parameters in acute kidney injury.
      Intrarenal backflow and its consequences such as submucosal edema and congestion may decrease
      blood flow especially around the calyces subject to high pressures and this situation may
      result in acute kidney injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.
time frame: The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation
description: Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.
PSV is the maximum velocity in the renal and arcuate arteries in the systolic phase of each heart pulse.
measure: End Diastolic Velocities (EDV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.
time frame: The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation
description: Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.
EDV is the velocity in the renal and arcuate arteries at the end of the diastolic phase of each heart pulse.
measure: Resistive Index (RI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.
time frame: The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation
description: Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.
Resistive index is calculated as the difference between PSV and EDV, divided by PSV [(PSV - EDV) / (PSV)].
An increased resistive index can be considered as a marker of intrarenal arterial stiffness and is associated with worsening of renal function and tubulointersitial damage.
measure: Pulsatility Index (PI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.
time frame: The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation
description: Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.
Pulsatility index is calculated as the difference between PSV and EDV, divided by the mean velocity [(PSV - EDV) / ((PSV + EDV) / 2)].
Pulsatility index is used to discriminate between renal and pre-renal causes of acute kidney injury which can alter the therapeutic options in the clinical setting.
measure: Technical Details - Size of Ureteral Access Sheath
time frame: 1 hour after the operation
description: The size of access sheaths will be given in French measurement. E.g. 10/12 Fr
measure: Technical Details - Name of Flexible Ureteroscope
time frame: 1 hour after the operation
description: Each ureteroscope has unique characteristics. So, every ureteroscope that will be used, will be recorded with its name. E.g. Storz Flex-X2, Olympus V1, Wolf Cobra
measure: Duration of the Flexible Ureteroscopy Operation
time frame: 10 minutes after the operation
description: the data about the duration of the operation that will be performed for each patient and the data will be recorded in minutes.
measure: Operative Characteristics - Irrigation Pressure
time frame: 1 hour after the operation
description: The pressure that is applied to the irrigation solution which is circulated through the ureteroscope that is used to expand the renal cavities during a flexible ureteroscopy operation. the data will be collected in cmH2O. This pressure value is a constant value and it doesn't change throughout the length of the procedure.
measure: Operative Characteristics - Intraoperative Complications
time frame: 1 hour after the operation
description: The number of patients that has experienced any kind of intraoperative complications during the flexible ureteroscopy operation.
measure: Post-Operative Characteristics - Complications
time frame: The data will be recorded within 1 month after each procedure.
description: The number of patients that had a complication in the first 1 month after the operation according to the Clavien Dindo Grading system (0-5).
Clavien Dindo Grading ranges from 0 (mildest) to 5 (most severe). 0. No complications
Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside
Complications requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included
Complications requiring surgical, endoscopic or radiological intervention
Life-threatening complications (including CNS complications) requiring IC/ICU management
Death
arm group label: Flexible ureteroscopy arm
arm group type: Experimental
description: the findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines Doppler Ultrasound examination has been performed in the pre-operative and post-operative periods
intervention type: Procedure
intervention name: flexible ureteroscopy
description: Flexible ureteroscopy is an endourological procedure performed for kidney stones. The flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During the operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and also to provide clear vision.
arm group label: Flexible ureteroscopy arm
intervention type: Device
intervention name: Doppler Ultrasound examination
description: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
arm group label: Flexible ureteroscopy arm
intervention type: Device
intervention name: laser lithotripsy
description: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and transmitted to the stones via the laser fiber.
arm group label: Flexible ureteroscopy arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tarik Emre Sener, Urologist
role: Principal Investigator
affiliation: Marmara University, School of Medicine, Department of Urology
citation: Schwalb DM, Eshghi M, Davidian M, Franco I. Morphological and physiological changes in the urinary tract associated with ureteral dilation and ureteropyeloscopy: an experimental study. J Urol. 1993 Jun;149(6):1576-85. doi: 10.1016/s0022-5347(17)36456-x.
PMID: 8501816
citation: de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17.
PMID: 24147820
citation: Sener TE, Cloutier J, Villa L, Marson F, Buttice S, Doizi S, Traxer O. Can We Provide Low Intrarenal Pressures with Good Irrigation Flow by Decreasing the Size of Ureteral Access Sheaths? J Endourol. 2016 Jan;30(1):49-55. doi: 10.1089/end.2015.0387. Epub 2015 Sep 18. Erratum In: J Endourol. 2017 Jan;31(1):110.
PMID: 26381037
responsible party type: Sponsor
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 