xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06012864</url>
    </required_header>
    <id_info>
      <org_study_id>Supine pediatric PNL</org_study_id>
      <nct_id>NCT06012864</nct_id>
    </id_info>
    <brief_title>Supine Versus Prone PNL in Pediatric</brief_title>
    <official_title>Modified Flank-free Supine Versus Prone PNL in Pediatric Renal Stones: A Prospective Randomized Comparative Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To Compare the safety and efficacy of PNL in a modified flank-free supine position versus&#xD;
        prone position in pediatric patients&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Incidence of pediatric urolithiasis varies from 5%-15% in developing countries to 1%-5% in&#xD;
        the developed ones. The 5-year recurrence rate of about55% (range, 38%-70%). Fernstrom and&#xD;
        Johansson first introduced percutaneous nephrolithotomy (PNL) in 1976. Since that PNL has&#xD;
        become widely used for multiple indications. Pediatric PNL was done in the prone position&#xD;
        with more rapid and easy puncture point determination, wider field for renal puncture, free&#xD;
        application of multiple accesses, and avoidance of visceral injuries, especially the colon.&#xD;
        PNL in the supine position has several advantages as, similar success rate and a shorter&#xD;
        operative time than conventional PNL. The Amplatz sheath is oriented downward, maintaining a&#xD;
        low pressure in the renal pelvis and reducing the fluid absorption with rapid drainage of the&#xD;
        fragmented stones. Furthermore, it's easier for the anesthesiologist to control the airway&#xD;
        and reduce the neural and ophthalmologic pressure lesions than the prone position. Desoky et&#xD;
        al in 2012 described the flank-free modified supine position (FFMSP) and claimed that this&#xD;
        position overcomes the mechanical limitation of ordinary supine position because of ample&#xD;
        space for puncture, dilatation, multiple tracts, and maneuverability of the system with the&#xD;
        nephoscope. Moreover, the surgeon can comfortably sit during the operation, and X-ray&#xD;
        exposure is reduced because puncture and dilatation are quite perpendicular to the body, and&#xD;
        the operator's hands are outside the fluoroscopic field. it's better to do supine PNL in case&#xD;
        of retro renal colon. as we see the supine position in pediatric is still under research and&#xD;
        few trials about it had been done with no clear recommendation, so we will compare PNL in&#xD;
        pediatric age group in modified free flank supine position versus prone position.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients divided into two groups (group A: modified supine PNL, group B: prone PNL)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>closed envelope</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>sucess rate</measure>
      <time_frame>within 3 months post operative</time_frame>
      <description>stone free rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>complication rate</measure>
      <time_frame>1 month</time_frame>
      <description>rate of patients develop complication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>operative time</measure>
      <time_frame>intraoperative</time_frame>
      <description>from the puncture untill the end</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Urolithiasis</condition>
    <arm_group>
      <arm_group_label>modified supine PNL</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients doing FFMS PNL</description>
    </arm_group>
    <arm_group>
      <arm_group_label>prone PNL</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients doing prone PNL</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PNL</intervention_name>
      <description>percutaneous extraction of the stones in the kidney</description>
      <arm_group_label>modified supine PNL</arm_group_label>
      <arm_group_label>prone PNL</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Age ≤ 18 years old. Renal stones are amenable for PNL with Guy's stone score 1-2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          congenital anomalies. skeletal anomalies. bleeding diathesis. active urinary tract&#xD;
          infection. Patient refusing participation. Patients with PCN.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmed Eltaher, MD</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>mostafa kamel, A L</last_name>
      <phone>01061133200</phone>
      <email>mostafa075@aun.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Assiut University Hospital</name>
        <address>
          <city>Assiut</city>
          <zip>11751</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>mostafa kamel, A L</last_name>
        <phone>01061133200</phone>
        <email>mostafa075@aun.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Holman E, Khan AM, Flasko T, Toth C, Salah MA. Endoscopic management of pediatric urolithiasis in a developing country. Urology. 2004 Jan;63(1):159-62; discussion 162. doi: 10.1016/j.urology.2003.08.043.</citation>
      <PMID>14751372</PMID>
    </reference>
    <reference>
      <citation>Lao M, Kogan BA, White MD, Feustel PJ. High recurrence rate at 5-year followup in children after upper urinary tract stone surgery. J Urol. 2014 Feb;191(2):440-4. doi: 10.1016/j.juro.2013.09.021. Epub 2013 Sep 16.</citation>
      <PMID>24050895</PMID>
    </reference>
    <reference>
      <citation>Liatsikos EN, Kallidonis P, Stolzenburg JU, Ost M, Keeley F, Traxer O, Bernardo N, Perimenis P, Smith AD. Percutaneous management of staghorn calculi in horseshoe kidneys: a multi-institutional experience. J Endourol. 2010 Apr;24(4):531-6. doi: 10.1089/end.2009.0264.</citation>
      <PMID>20218888</PMID>
    </reference>
    <reference>
      <citation>Caione P, De Dominicis M, Collura G, Matarazzo E, Nappo SG, Capozza N. Microperc for pediatric nephrolithiasis: technique in valdivia-modified position. Eur J Pediatr Surg. 2015 Feb;25(1):94-9. doi: 10.1055/s-0034-1387939. Epub 2014 Sep 13.</citation>
      <PMID>25217714</PMID>
    </reference>
    <reference>
      <citation>Desoky EAE, Sakr AM, ElSayed ER, Ali MM. Ultra-Mini-Percutaneous Nephrolithotomy in Flank-Free Modified Supine Position vs Prone Position in Treatment of Pediatric Renal Pelvic and Lower Caliceal Stones. J Endourol. 2022 May;36(5):610-614. doi: 10.1089/end.2021.0557. Epub 2022 Mar 9.</citation>
      <PMID>34861776</PMID>
    </reference>
    <reference>
      <citation>Falahatkar S, Moghaddam AA, Salehi M, Nikpour S, Esmaili F, Khaki N. Complete supine percutaneous nephrolithotripsy comparison with the prone standard technique. J Endourol. 2008 Nov;22(11):2513-7. doi: 10.1089/end.2008.0463.</citation>
      <PMID>19046091</PMID>
    </reference>
    <reference>
      <citation>Vicentini FC, Torricelli FC, Mazzucchi E, Hisano M, Murta CB, Danilovic A, Claro JF, Srougi M. Modified complete supine percutaneous nephrolithotomy: solving some problems. J Endourol. 2013 Jul;27(7):845-9. doi: 10.1089/end.2012.0725. Epub 2013 Jun 8.</citation>
      <PMID>23373958</PMID>
    </reference>
    <reference>
      <citation>Kukreja RA, Desai MR, Sabnis RB, Patel SH. Fluid absorption during percutaneous nephrolithotomy: does it matter? J Endourol. 2002 May;16(4):221-4. doi: 10.1089/089277902753752160.</citation>
      <PMID>12042103</PMID>
    </reference>
    <reference>
      <citation>Desoky EA, Allam MN, Ammar MK, Abdelwahab KM, Elsaid DA, Fawzi AM, Alayman AA, Shahin AM, Kamel HM. Flank free modified supine position: A new modification for supine percutaneous nephrolithotomy. Arab J Urol. 2012 Jun;10(2):143-8. doi: 10.1016/j.aju.2011.12.008. Epub 2012 Mar 7.</citation>
      <PMID>26558017</PMID>
    </reference>
    <reference>
      <citation>De Sio M, Autorino R, Quarto G, Calabro F, Damiano R, Giugliano F, Mordente S, D'Armiento M. Modified supine versus prone position in percutaneous nephrolithotomy for renal stones treatable with a single percutaneous access: a prospective randomized trial. Eur Urol. 2008 Jul;54(1):196-202. doi: 10.1016/j.eururo.2008.01.067. Epub 2008 Feb 4.</citation>
      <PMID>18262711</PMID>
    </reference>
    <reference>
      <citation>Emiliani E, Quiroz YY, Llorens E, Quintian C, Motta G, Villada D, Bujons A. Retrorenal colon in pediatric patients with urolithiasis: Is the supine position for PCNL advantageous? J Pediatr Urol. 2022 Dec;18(6):741.e1-741.e6. doi: 10.1016/j.jpurol.2022.07.028. Epub 2022 Aug 3.</citation>
      <PMID>35985922</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mostafa Kamel Abdel Rahman</investigator_full_name>
      <investigator_title>DR</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urolithiasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06012864
  org study id: Supine pediatric PNL
  nct id: NCT06012864
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To Compare the safety and efficacy of PNL in a modified flank-free supine position versus
        prone position in pediatric patients
  Incidence of pediatric urolithiasis varies from 5%-15% in developing countries to 1%-5% in
        the developed ones. The 5-year recurrence rate of about55% (range, 38%-70%). Fernstrom and
        Johansson first introduced percutaneous nephrolithotomy (PNL) in 1976. Since that PNL has
        become widely used for multiple indications. Pediatric PNL was done in the prone position
        with more rapid and easy puncture point determination, wider field for renal puncture, free
        application of multiple accesses, and avoidance of visceral injuries, especially the colon.
        PNL in the supine position has several advantages as, similar success rate and a shorter
        operative time than conventional PNL. The Amplatz sheath is oriented downward, maintaining a
        low pressure in the renal pelvis and reducing the fluid absorption with rapid drainage of the
        fragmented stones. Furthermore, it's easier for the anesthesiologist to control the airway
        and reduce the neural and ophthalmologic pressure lesions than the prone position. Desoky et
        al in 2012 described the flank-free modified supine position (FFMSP) and claimed that this
        position overcomes the mechanical limitation of ordinary supine position because of ample
        space for puncture, dilatation, multiple tracts, and maneuverability of the system with the
        nephoscope. Moreover, the surgeon can comfortably sit during the operation, and X-ray
        exposure is reduced because puncture and dilatation are quite perpendicular to the body, and
        the operator's hands are outside the fluoroscopic field. it's better to do supine PNL in case
        of retro renal colon. as we see the supine position in pediatric is still under research and
        few trials about it had been done with no clear recommendation, so we will compare PNL in
        pediatric age group in modified free flank supine position versus prone position.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients divided into two groups (group A: modified supine PNL, group B: prone PNL)
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: closed envelope
  measure: sucess rate
  time frame: within 3 months post operative
  description: stone free rate
  measure: complication rate
  time frame: 1 month
  description: rate of patients develop complication
  measure: operative time
  time frame: intraoperative
  description: from the puncture untill the end
  arm group label: modified supine PNL
  arm group type: Experimental
  description: patients doing FFMS PNL
  arm group label: prone PNL
  arm group type: Experimental
  description: patients doing prone PNL
  intervention type: Procedure
  intervention name: PNL
  description: percutaneous extraction of the stones in the kidney
  arm group label: modified supine PNL
  arm group label: prone PNL
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmed Eltaher, MD
  role: Study Director
  affiliation: Assiut University
  last name: mostafa kamel, A L
  phone: 01061133200
  email: mostafa075@aun.edu.eg
  facility: 
  contact: 
  country: Egypt
  citation: Holman E, Khan AM, Flasko T, Toth C, Salah MA. Endoscopic management of pediatric urolithiasis in a developing country. Urology. 2004 Jan;63(1):159-62; discussion 162. doi: 10.1016/j.urology.2003.08.043.
  PMID: 14751372
  citation: Lao M, Kogan BA, White MD, Feustel PJ. High recurrence rate at 5-year followup in children after upper urinary tract stone surgery. J Urol. 2014 Feb;191(2):440-4. doi: 10.1016/j.juro.2013.09.021. Epub 2013 Sep 16.
  PMID: 24050895
  citation: Liatsikos EN, Kallidonis P, Stolzenburg JU, Ost M, Keeley F, Traxer O, Bernardo N, Perimenis P, Smith AD. Percutaneous management of staghorn calculi in horseshoe kidneys: a multi-institutional experience. J Endourol. 2010 Apr;24(4):531-6. doi: 10.1089/end.2009.0264.
  PMID: 20218888
  citation: Caione P, De Dominicis M, Collura G, Matarazzo E, Nappo SG, Capozza N. Microperc for pediatric nephrolithiasis: technique in valdivia-modified position. Eur J Pediatr Surg. 2015 Feb;25(1):94-9. doi: 10.1055/s-0034-1387939. Epub 2014 Sep 13.
  PMID: 25217714
  citation: Desoky EAE, Sakr AM, ElSayed ER, Ali MM. Ultra-Mini-Percutaneous Nephrolithotomy in Flank-Free Modified Supine Position vs Prone Position in Treatment of Pediatric Renal Pelvic and Lower Caliceal Stones. J Endourol. 2022 May;36(5):610-614. doi: 10.1089/end.2021.0557. Epub 2022 Mar 9.
  PMID: 34861776
  citation: Falahatkar S, Moghaddam AA, Salehi M, Nikpour S, Esmaili F, Khaki N. Complete supine percutaneous nephrolithotripsy comparison with the prone standard technique. J Endourol. 2008 Nov;22(11):2513-7. doi: 10.1089/end.2008.0463.
  PMID: 19046091
  citation: Vicentini FC, Torricelli FC, Mazzucchi E, Hisano M, Murta CB, Danilovic A, Claro JF, Srougi M. Modified complete supine percutaneous nephrolithotomy: solving some problems. J Endourol. 2013 Jul;27(7):845-9. doi: 10.1089/end.2012.0725. Epub 2013 Jun 8.
  PMID: 23373958
  citation: Kukreja RA, Desai MR, Sabnis RB, Patel SH. Fluid absorption during percutaneous nephrolithotomy: does it matter? J Endourol. 2002 May;16(4):221-4. doi: 10.1089/089277902753752160.
  PMID: 12042103
  citation: Desoky EA, Allam MN, Ammar MK, Abdelwahab KM, Elsaid DA, Fawzi AM, Alayman AA, Shahin AM, Kamel HM. Flank free modified supine position: A new modification for supine percutaneous nephrolithotomy. Arab J Urol. 2012 Jun;10(2):143-8. doi: 10.1016/j.aju.2011.12.008. Epub 2012 Mar 7.
  PMID: 26558017
  citation: De Sio M, Autorino R, Quarto G, Calabro F, Damiano R, Giugliano F, Mordente S, D'Armiento M. Modified supine versus prone position in percutaneous nephrolithotomy for renal stones treatable with a single percutaneous access: a prospective randomized trial. Eur Urol. 2008 Jul;54(1):196-202. doi: 10.1016/j.eururo.2008.01.067. Epub 2008 Feb 4.
  PMID: 18262711
  citation: Emiliani E, Quiroz YY, Llorens E, Quintian C, Motta G, Villada D, Bujons A. Retrorenal colon in pediatric patients with urolithiasis: Is the supine position for PCNL advantageous? J Pediatr Urol. 2022 Dec;18(6):741.e1-741.e6. doi: 10.1016/j.jpurol.2022.07.028. Epub 2022 Aug 3.
  PMID: 35985922
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mostafa Kamel Abdel Rahman
  investigator title: DR
  mesh term: Urolithiasis
  sharing ipd: No