<?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>IRCT138707201323N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-12-20</date_registration>
      <primary_sponsor>Research manager, Yasuj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of efficacy and complications of PCNL under General and Spinal anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of efficacy and complications of PCNL under General and Spinal anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>1</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/570</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Renal and ureteral stones.</hc_freetext>
      <i_freetext>Intervention 1: Performing PCNL under spinal anesthesia at the prone position. Intervention 2: Performing PCNL under general anesthesia at the prone position.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>           Background: The aim of this study is Comparison of efficacy, complications and patient satisfaction from percutaneous nephrolithotomy (PCNL) in prone and supine position under spinal anesthesia.&lt;br /&gt;&#13;
Materials and methods:  In this clinical trial 60 patients candidate for PCNL after taking consent form ‚ randomly assigned in two groups. In group 1 PCNL was done in supine position under spinal anesthesia by standard method. In group 2 after changing patients to prone position PCNL was done as first group.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
In both groups after operation patients satisfaction from position during operation was checked by Beck scale. Two weeks later patients again visit and efficacy of operation checked by KUB and ultrasonography. All data records and analysed by SPSS software and statistical Tests.&lt;br /&gt;&#13;
Results: Mean operative time was similar in the two groups (112±24.5 minute in supine and 109±19.7 minute in prone) (p=0.18)&lt;br /&gt;&#13;
The mean hospital stay in supine position and prone position were 2.44±1.02 and 2.12 ±0.56 days respectively (p&gt;0.05). The patient’s satisfaction was more from operation in supine position (89.7 %in supine and 61.4 in prone position (P=0.018).&lt;br /&gt;&#13;
There was no significant differences between the supine and prone position in complications (p=0.3). Considering efficacy and success of operation in supine and prone position it was 69% and 58.4% respectively (p=0.195).&lt;br /&gt;&#13;
Conclusion: PCNL in supine position is a safe procedure and with similar performance compared to standard prone position for treatment of urolithiasis and patient 'satisfaction is more from this position although more studies with larger sample size are necessary&lt;br /&gt;&#13;
Key word: percutaneous nephrolithotomy‚position‚efficacy‚complications&lt;br /&gt;&#13;
</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>Yasuj University of Medical Sciences, Motahari street,</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 1333 7228</telephone>
        <email>mehrabi390@yahoo.com and dr mehrabiyums.ac.ir</email>
        <affiliation>Yasuj university of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sadrollah Mehrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj University of Medical Sciences, Motahari street,</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>759741417</zip>
        <telephone>+98 74 1222 6517</telephone>
        <email>mehrabi390@yahoo.com and dr mehrabiyums.ac.ir</email>
        <affiliation>Yasuj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age more than 18 years, presence of renal or upper ureteral stone, candidate for PCNL (multiple stones, staghorn stones, calyceal diverticule stones, stone which are resistant to ESWL, lower pole renal stone larger than &gt;15 mm and other renal stone larger than 25 mm, upper ureteral stone &gt;20mm, Having informed consent &#13;
Exclusion criteria: Any contraindication for regional anesthesia, presence of coagulopathy, acute infection ore urosepsis, presence of acute renal failure</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</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 PCNL under spinal anesthesia at the prone position</i_keyword>
      <i_keyword>Performing PCNL under general anesthesia at the prone position</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Success rate of operation. 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. Timepoint: during operation to one week later. Method of measurement: report of patients and observation with examination of patients.</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>Research manager, Yasuj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-02-09</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Imam Sajad hospital, Yasuj university of medical science, Yasuj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
