<?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>IRCT20220131053898N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-15</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Studying the effect of Tamsulosin on postoperative urinary retention in patients undergoing inguinal hernia repair under spinal anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of Tamsulosin on postoperative urinary retention in patients undergoing Inguinal hernia repair under spinal anesthesia at IMam sajjad hospital in 2022</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61646</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, block randomization will be used to generate a random sequence.  The size of the blocks is selected randomly (blocks of 6 and 4).  Each block contains an equal number of each group.  Random sequence generation software will be used to generate random sequences.  To hide random allocation, opaque envelopes sealed with random sequences will be used.  Each random sequence is recorded on a card, and the cards are placed in the envelopes of the order, respectively.  In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface.  At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed, Blinding description: Enrolled patients and the responsible nurse for providing the medications are unaware of the type of medicine used for their case.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Post inguinal hernioplasty urinary retention.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients inguinal hernia is confirmed by physical examination or sonography. All patients are kept NPO(nil per os ) 8 hours before the surgery and they receive 1 liter of dextrose saline solution . They receive tamsulosin 0.4 mg from Abidi company 8 hours before the surgery and 6,12 hours after the surgery . Intervention 2: Control group: patients inguinal hernia is confirmed by physical examination or sonography. All patients are kept NPO(nil per os ) 8 hours before the surgery and they receive 1 liter of dextrose saline solution . They receive a gelatinous capsule containing glucose  8 hours before the surgery and 6,12 hours after the 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Specific part of data except personal name and ID would be shared with other researchers in future

When:
We can share our data after publishing an article

To whom:
Researchers from other universities

Conditions:
They can use it only if they mention the names of the researchers of this study

Where to obtain:
email

How to obtain:
Through academic email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Hadizadeh Neisanghalb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr blvd., Jouybar three way</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4691710001</zip>
        <telephone>+98 11 5509 1101</telephone>
        <email>h.of.mohammad@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hadizadeh Neisanghalb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr blvd., Jouybar three way, Imam square</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4691710001</zip>
        <telephone>+98 11 5509 1101</telephone>
        <email>h.of.mohammad@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age older than 50 years old
Unilateral inguinal hernia
Candidate for spinal anesthesia</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Bilateral hernia
Strangulated hernia
General anesthesia
Prostate cancer
BPH
Orthostatic hypotention
Concurrent surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K40.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unilateral inguinal hernia, without obstruction or gangrene</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: patients inguinal hernia is confirmed by physical examination or sonography. All patients are kept NPO(nil per os ) 8 hours before the surgery and they receive 1 liter of dextrose saline solution . They receive tamsulosin 0.4 mg from Abidi company 8 hours before the surgery and 6,12 hours after the surgery .</i_keyword>
      <i_keyword>Control group: patients inguinal hernia is confirmed by physical examination or sonography. All patients are kept NPO(nil per os ) 8 hours before the surgery and they receive 1 liter of dextrose saline solution . They receive a gelatinous capsule containing glucose  8 hours before the surgery and 6,12 hours after the surgery .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post operative urinary retention. Timepoint: In the next 24 hours after surgery. Method of measurement: Ability to urinate.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-01</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vali Asr blvd., Jouybar tree way, Imam square Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
