<?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>IRCT20090427001853N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-24</date_registration>
      <primary_sponsor>Urology Research Center, Guilan University of Medical Sciences</primary_sponsor>
      <public_title>Safety of omitting antibiotic prophylaxis prior to Transurethral Lithotripsy (TUL)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of safety of omitting antibiotic prophylaxis prior to Transurethral Lithotripsy (TUL) in two groups of patients with and without positive urine culture referred to Razi Hospital in Rasht: a pilot study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58753</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postoperative complication.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Omitting prophylactic antibiotic therapy prior to Transurethral Lithotripsy (TUL) in patients with positive urine culture in whom routinely antibiotics are continued until urine culture become negative. Intervention 2: Control group: Patients without positive urine culture in whom antibiotic is not prescribed as standard prior to Transurethral Lithotripsy (TUL).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the possibility of prolonging the study and publication of the article, researchers will decide regarding the details of sharing the unidentifiable personal data of the participants after the end of the study and publication of the results in the form of an article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Falahatkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar-e-Jangal Street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41448-95655</zip>
        <telephone>+98 13 3352 5259</telephone>
        <email>rfalahatkar76@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Siavash Falahatkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar-e-Jangal Street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41448-95655</zip>
        <telephone>+98 13 3352 5259</telephone>
        <email>falahatkar_s@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with lower and middle ureteral stones who are candidates for Transurethral Lithotripsy (TUL)
Age between 15 and 65 years
Patient consent to participate in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Upper urinary tract infection based on symptoms of fever, shivering, flank pain and leukocytosis
Use of preoperative antibiotics
Drug abuse
Patients with single kidney
Uncontrolled systemic diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N99.89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other postprocedural complications and disorders of genitourinary system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Omitting prophylactic antibiotic therapy prior to Transurethral Lithotripsy (TUL) in patients with positive urine culture in whom routinely antibiotics are continued until urine culture become negative</i_keyword>
      <i_keyword>Control group: Patients without positive urine culture in whom antibiotic is not prescribed as standard prior to Transurethral Lithotripsy (TUL)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative fever. Timepoint: After the operation until the time of discharge. Method of measurement: Examination.</prim_outcome>
      <prim_outcome>Postoperative urinary tract infection. Timepoint: 48 hours after surgery. Method of measurement: Urine culture.</prim_outcome>
      <prim_outcome>Postoperative complications. Timepoint: After the operation until the time of discharge. Method of measurement: Examination and laboratory tests.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Success rate (stone free rate). Timepoint: 1 month after surgery. Method of measurement: Sonography, CT-scan.</sec_outcome>
      <sec_outcome>Operation time. Timepoint: From start to recovery. Method of measurement: Stopwatch.</sec_outcome>
      <sec_outcome>Hospital stay. Timepoint: On the day of discharge. Method of measurement: Hospitalization days.</sec_outcome>
      <sec_outcome>Analgesic use. Timepoint: After surgery, during the period of hospitalization. Method of measurement: Question from the patient, examination.</sec_outcome>
      <sec_outcome>Readmission. Timepoint: Up to one month after surgery. Method of measurement: Question from the patient.</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>Urology Research Center, Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-01</approval_date>
        <contact_name>Ethics Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Sardar Jangal street Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
