<?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>IRCT20090427001853N18</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-21</date_registration>
      <primary_sponsor>Urology Research Center, Guilan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of total tubeless PCNL and tubeless PCNL on the outcomes of complete supine percutaneous nephrolithotomy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of total tubeless PCNL and tubeless PCNL on the outcomes of complete supine percutaneous nephrolithotomy (csPCNL): a single-blind randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65312</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Block randomization with blocks of 4 through a table of random numbers with a ratio of 1 to 1 (in two groups A and B) using a randomizer through the sealed envelope online program, Blinding description: One of the researchers (urology resident) divides the patients into two groups A (tubeless PCNL) and B (total tubeless PCNL) based on the table prepared from random blocks. The surgeon does not know the patient group until the operation time. The analyst will also be unaware of the type of patient grouping. At the top of the checklist that is completed for each patient, the type of group (A or B) is mentioned.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Postoperative complication of stent.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the total tubeless PCNL group, at the end of the procedure, no stent will be implanted for the patient and the patient will be completely tubeless. Intervention 2: Control group: In the tubeless PCNL group, external stents are implanted for all patients after surgery.</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>Shahab Aali</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>Shahab.aali@yahoo.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>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 20 years
Consent of patients to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Metabolic disease known to predispose to stones
Transplanted kidney stones
Renal failure requiring chronic dialysis before surgery
Anatomical problems (ureteral stricture, duplicate ureter, single kidney,...)
Bleeding during surgery
Occurrence of any surgical complications during the operation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y40-Y59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Drugs, medicaments and biological substances causing adverse effects in therapeutic use</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>Intervention group: In the total tubeless PCNL group, at the end of the procedure, no stent will be implanted for the patient and the patient will be completely tubeless.</i_keyword>
      <i_keyword>Control group: In the tubeless PCNL group, external stents are implanted for all patients after surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative fever. Timepoint: After the operation until the time of discharge. Method of measurement: Examination using a thermometer.</prim_outcome>
      <prim_outcome>Postoperative infection. Timepoint: 48 hours after surgery. Method of measurement: Lab test and urine culture.</prim_outcome>
      <prim_outcome>Postoperative hemoglobin. Timepoint: 24 hours after surgery. Method of measurement: Complete blood count (CBC) test.</prim_outcome>
      <prim_outcome>Postoperative creatinine. Timepoint: 24 hours after surgery. Method of measurement: Blood test by kinetic Jaffe's and enzymatic method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>2022-07-20</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>
