<?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>IRCT201212291323N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-02-11</date_registration>
      <primary_sponsor>Deputy of information and Research , Yasuj University of Medical Science</primary_sponsor>
      <public_title>sterile water and normal saline in PCNL</public_title>
      <acronym></acronym>
      <scientific_title>comparison of  efficacy and adverse effects of sterile water and normal saline for irrigation fluid   in percutneous nephrolithotripsy(PCNL)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/574</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>Calculus of kidney with calculus of ureter.</hc_freetext>
      <i_freetext>Intervention 1: Case group :use of sterile water as an irrigation fluid during PCNL operation. Intervention 2: control group :use of normal saline  as an irrigation fluid during PCNL operation.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>J Mazand Univ Med Sci 2013; 23(106): (Persian).</results_url_link>
      <results_summary>           Comparison of the Efficacy and Adverse Effects of Sterile Water with&lt;br /&gt;&#13;
Normal Saline in Percutaneous Nephrolithotomy (PCNL)&lt;br /&gt;&#13;
Sadrollah Mehrabi1,&lt;br /&gt;&#13;
Samira Nazari2,&lt;br /&gt;&#13;
Hammidreza Ghafarian Shirazi3,&lt;br /&gt;&#13;
Abolghasem Hadinia4,&lt;br /&gt;&#13;
1 Professor, Social Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran&lt;br /&gt;&#13;
2 General Practitioner, Students Research committee, Yasuj University of Medical Sciences, Yasuj, Iran&lt;br /&gt;&#13;
3 Assistant Professor, Social Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran&lt;br /&gt;&#13;
4 Lecturer, Cellular and Molecular Research Center, Yasuj University of Medical Sciences, Yasuj, Iran&lt;br /&gt;&#13;
(Received July 14, 2012; Accepted December 15, 2012)&lt;br /&gt;&#13;
Abstract&lt;br /&gt;&#13;
Background and purpose: The irrigation fluid that routinely used during percutaneous nephrolithotomy&lt;br /&gt;&#13;
(PCNL) has systemic absorption. The aim of this study was comparing the efficacy and adverse effects of sterile&lt;br /&gt;&#13;
water and normal saline as an irrigant fluid in PCNL.&lt;br /&gt;&#13;
Materials and methods: Ninety four older than 18 years old patients with renal or upper ureteral stones&lt;br /&gt;&#13;
that were candidate for PCNL randomly allocated in two groups. Patient with American Society of Anesthesiologists&lt;br /&gt;&#13;
(ASA) score 3 and 4 and history of hemolysis excluded from study. From all patient, serum base laboratory and&lt;br /&gt;&#13;
serum electrolyte was taken. Then, under spinal anesthesia PCNL was done with fluoroscope guidance in standard&lt;br /&gt;&#13;
method with use of normal saline in first group. In second group, PCNL with fluoroscope guidance in standard&lt;br /&gt;&#13;
method with use of sterile water was done, too. Preoperative, intraoperative and postoperative variables such as&lt;br /&gt;&#13;
serum sodium, potassium and haptoglobin, cost and duration of surgery, pulmonary and cardiovascular&lt;br /&gt;&#13;
complications compared between two groups. Data was collected and analyzed using chi-square and paired -t tests.&lt;br /&gt;&#13;
Results: Demographic characteristics, operation time, serum electrolytes and volume of irrigation fluid were&lt;br /&gt;&#13;
similar in two groups. Mean postoperative haptoglobin in group one and two were 1.15 ± 0.38 and 1.29 ± 0.53 mg/dl&lt;br /&gt;&#13;
respectively (P = 0.263). Mean cost in group one and two were 117,234 and 25,400 Rial, respectively and there were&lt;br /&gt;&#13;
no cardiovascular and pulmonary complications.&lt;br /&gt;&#13;
Conclusion: Use of sterile water as an irrigation fluid in PCNL is inexpensive, safe and more available and&lt;br /&gt;&#13;
have not more complications in compare with normal saline that can be used as an alternative fluid in PCNL&lt;br /&gt;&#13;
operation.&lt;br /&gt;&#13;
Keywords: Sterile water, normal saline, PCNL</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>Montazeri street,Shaheed Beheshti Hospital,</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 1222 1813</telephone>
        <email>sadrollahm@yahoo.com and dr mehrabiyums.ac.ir</email>
        <affiliation>Social Health Determinant of research center,Yasuj university of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sadrollah Mehrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Block 22,no1,bahonar street,Dr Mehrabi</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 74 1222 1813</telephone>
        <email>sadrollahm@yahoo.com and  dr.mehrabi@yums.ac.ir</email>
        <affiliation>Social determinant of health research center,, Yasuj University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion and exclusion criteria  are includes (Inclusion criteria:Age&gt;18 years old ,patients with renal or upper  ureteral stone larger than 20 millimeter candidate for percutaneous nephrolithotripsy , &#13;
 Exclusion criteria: patients  with urinary stone younger than 18 years old  ,patients with azotemia.uncontrolled coagulopathy,active infection,history of hemolysis,any contraindication for general or spinal anesthesia,COPD,ASA score 3 and 4 )</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>Case group :use of sterile water as an irrigation fluid during PCNL operation</i_keyword>
      <i_keyword>control group :use of normal saline  as an irrigation fluid during PCNL operation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cheke of  serum electrolytes and hemolysis in percutaneous nephrolithotripsy. Timepoint: Before operation and 6 hour after operation. Method of measurement: checking Na,K,and serum haptoglubin before and 6 hour operation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Development of any cardiovascular or pulmonary complications. Timepoint: during operation to one week later. Method of measurement: report of patients and observation with examination lung and heart of  of patients pulse oximetery during operation,and check of lower limb pulses.</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>Deputy of information and Research , Yasuj University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-03-01</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Motahari street,yasuj university of medical sciences Yasuj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
