<?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>IRCT20160406027253N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-02</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>A clinical trial to compare the amount of bleeding and surgical complications of percutaneous nephrolithotomy in a group that had a balloon nephrostomy compared to a normal nephrostomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of blood loss and complications in patients underwent percutaneous nephrolithotomy with balloon traction of nephrostomy and conventional methods: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72773</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process has already been done by Stata software, and the number of patients has been divided into binary and quadruple blocks by using the Random allocation command in Stata, and the patient number and the group in which the random allocation is placed in the sealed envelopes. At the end of the operation, the envelopes are opened and based on the contents of the envelope, a normal nephrostomy or a balloon nephrostomy is placed inside the pelvis and the balloon is filled a little and then traction is applied on the skin to put pressure on the calyx of the access site, Blinding description: Equality of nephrostomy ends outside body ensures the unawareness of participants to allocation groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>kidney stone.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, a balloon nephrostomy was placed under fluoroscopy at the infundibulum entrance of the access site from the pelvic side, and tamponade was performed on the calyx of the access site with brief traction on the balloon. Intervention 2: Control group: In the control group, which is the control group, the nephrostomy point was inserted in the conventional way. Then the hemoglobin drop and complications in these two groups were compared.</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 .upon request of the publishing journal is publishable</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Amirhossein Kashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Pasdaran St., Shahid Jafari St. (9th Bostan), next to Shahid Labaghinejad Hospital, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1666663111</zip>
        <telephone>+98 21 2258 8016</telephone>
        <email>ahkashi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Akbar Nouralizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Pasdaran St., Shahid Jafari St. (9th Bostan), next to Shahid Labaghinejad Hospital, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1666663111</zip>
        <telephone>+98 21 2258 8016</telephone>
        <email>ahkashi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Kidney stones are candidates for PCNL surgery
Age 18 years and older
Placement in group one ASA I,II in terms of anesthesia risk</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age under 18 years old
Patients with kidney stones with anatomical abnormalities(Renal malrotation, pelvic kidney, horseshoe kidney
Paranchymal atrophy and kidney with little function
Placement in group one ASA III in terms of anesthesia risk
High Creatinine
BMI over 30 Kg/m2
Untreated coagulation disorder
Aspirin consumption in the last 7 days
Taking NSAID drugs in the last 5 days
Untreated active urinary tract infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N 20.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calculus of kidney</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 intervention group, a balloon nephrostomy was placed under fluoroscopy at the infundibulum entrance of the access site from the pelvic side, and tamponade was performed on the calyx of the access site with brief traction on the balloon.</i_keyword>
      <i_keyword>Control group: In the control group, which is the control group, the nephrostomy point was inserted in the conventional way. Then the hemoglobin drop and complications in these two groups were compared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stone cleaning. Timepoint: 24 hours after the intervention. Method of measurement: Plain radiography of the abdomen.</prim_outcome>
      <prim_outcome>Transfusion Rate. Timepoint: From the start of surgery until time of discharge from the hospital. Method of measurement: The number of units of blood transfused during hospitalization.</prim_outcome>
      <prim_outcome>Urinary leak volume. Timepoint: During hospitalization. Method of measurement: CC volume of urine removed from the nephrostomy site.</prim_outcome>
      <prim_outcome>Changes in hemoglobin. Timepoint: End of operation and 24 hours after surgery. Method of measurement: mg/dL based on laboratory measurement.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Creatinine change. Timepoint: preoperative and 24-48 hours after surgery. Method of measurement: based on serum levels of creatinine before and after operation.</sec_outcome>
      <sec_outcome>Hospitalization duration. Timepoint: from hospitalization to discharge. Method of measurement: days.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-25</approval_date>
        <contact_name>Research Ethics Committee of Kidney Diseases Research Center- Shahid Beheshti University of Sciences</contact_name>
        <contact_address>No. 44, Pasdaran St., Shahid Jafari St. (9th Bostan), next to Shahid Labaghinejad Hospital, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
