<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201509111323N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-02-28</date_registration>
      <primary_sponsor>Vice Chancellor for research of Yasuj University of Medical Sciences</primary_sponsor>
      <public_title>Position and  Percutaneous Nephrolithotomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of efficacy and complications of tubeless Percutaneous Nephrolithotomy  in prone and supine position under spinal anesthesia in adult patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/578</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: For randomization of patients to one of two groups of interventions block randomization with four block were used.</study_design>
      <phase>2</phase>
      <hc_freetext>Renal and ureteral stones.</hc_freetext>
      <i_freetext>Intervention 1: Performing  tubeless percutaneous nephrolithotomy(Tubeless)  under spinal anesthesia in prone position  &#13;
 in Group 1 (prone position) after prep of patients under spinal anesthesia( 2، 2.5 milliliter of bupivacaine and 0.5 milliliter of fentanyl) ureteral catheter 5،6 F will be inserted in ureter in the lithotomy position .Then the patient position will be changed  in prone position and with fluoroscopic guidance PCNL will performed using standard methods without nephrostomy tube. Intervention 2: Performing  tubeless percutaneous nephrolithotomy(Tubeless)  under spinal anesthesia in supine position &#13;
 in Group 2 ( Supine position) after prep of patients under spinal anesthesia (2، 2.5 milliliter of bupivacaine and 0.5 milliliter of fentanyl) ureteral catheter 5،6F will be inserted in ureter in the lithotomy position .Then the patient position will be changed to supine  position and with fluoroscopic guidance PCNL will performed using standard methods without nephrostomy tube.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Sadrollah Mehrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Education vice chancellor, Yasuj University of Medical Sciences,  Mottahari street, Yasuj, Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 3334 6070</telephone>
        <email>sadrollahm@yahoo.com ; dr.mehrabiyums.ac.ir</email>
        <affiliation>Yasuj university of medical science ,Yasuj,Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sadrollah Mehrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>22 Block, No 1, Shahid Bahonar street, Yasuj, Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591951176</zip>
        <telephone>+98 74 3334 6070</telephone>
        <email>dr.mehrabi@yums.ac.ir; sadrollahm@yahoo.com</email>
        <affiliation>Faculty of Medicine, Yasuj university of medical science, Yasuj, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with renal or upper ureteral stones more than 15-20 mm aged18 years and over candidate for PCNL( stones resistant to ESWL‚ multiple stones and staghorn kidney stones); &#13;
&#13;
Exclusion criteria: Patients with severe cardiovascular or pulmonary disease, uncontrolled coagulopathy, scoliosis or kyphosis, pregnant patients and those with any contraindication for general or spinal anesthesia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N20.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calculus of kidney with calculus of ureter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Performing  tubeless percutaneous nephrolithotomy(Tubeless)  under spinal anesthesia in prone position  &#13;
 in Group 1 (prone position) after prep of patients under spinal anesthesia( 2، 2.5 milliliter of bupivacaine and 0.5 milliliter of fentanyl) ureteral catheter 5،6 F will be inserted in ureter in the lithotomy position .Then the patient position will be changed  in prone position and with fluoroscopic guidance PCNL will performed using standard methods without nephrostomy tube</i_keyword>
      <i_keyword>Performing  tubeless percutaneous nephrolithotomy(Tubeless)  under spinal anesthesia in supine position &#13;
 in Group 2 ( Supine position) after prep of patients under spinal anesthesia (2، 2.5 milliliter of bupivacaine and 0.5 milliliter of fentanyl) ureteral catheter 5،6F will be inserted in ureter in the lithotomy position .Then the patient position will be changed to supine  position and with fluoroscopic guidance PCNL will performed using standard methods without nephrostomy tube.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Success rate of operation and stone crushing. Timepoint: during operation and two week later. Method of measurement: observation by nephroscope and fluroscopy during operation and with sonography and KUB two weeks later.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Any complications of surgery(Pulmonary, vascular, visceral,  neurologic and others). Timepoint: During operation to two week later. Method of measurement: Report of patients and physician and observation with examination of patients lung,checking sensory and motors and pulse of extremities    and ultrasonography.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>-</sec_id>
        <issuing_authority>-</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for research of Yasuj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-23</approval_date>
        <contact_name>Ettics committee of Yasuj University of medical sciences</contact_name>
        <contact_address>Mottahari street, Yasuj University of medical sciences, Yasuj, Iran Yasuj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
