<?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>IRCT2014061013938N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-07-20</date_registration>
      <primary_sponsor>Investigation secretary of tabriz university of medical sciences</primary_sponsor>
      <public_title>effect of two different surgical techniques on amount of nasal mucosal tear</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of rate and severity of nasal mucosal tear with internal and external lateral nasal  osteotomy using endoscope</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13654</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>nasal mucosal tear.</hc_freetext>
      <i_freetext>Intervention 1: intervention group:  after induction of general anesthesia and injection of 10 cc of 1:200000 epinephrine solution at lateral nasal walls and nasal dorsum the surgery was began,3mm osteotome without guard was introduced  through skin at the midway between inner canthus and vestibule. when the  cutting edge of osteotome reached bone the external osteotomy was initiated . In a blinded manner, another investigator used nasal endoscopy to detect nasal mucosal tears and reported them in millimeter (mm). Intervention 2: control group: after induction of general anesthesia and injection of 10 cc of 1:200000 epinephrine solution at lateral nasal walls and nasal dorsum the surgery was began. mucosal incision was made at the lateral nasal wall just above the junction of inferior turbinate.after introduction of 3mm guarded osteotome the internal osteotomy was initiated and completed at the level of the inner canthus . In a blinded manner, another investigator used nasal endoscopy to detect nasal mucosal tears and reported them in millimeter (mm).</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Doctor alihosein mesgarzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Danshgah square,daneshgah avenue,dentistry faculty,maxillofacial surgery ward</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 5965</telephone>
        <email>mesgarcu@hotmail.com</email>
        <affiliation>Tabriz university of medical sciences/denistry faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor alihosein mesgarzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Danshgah square,daneshgah avenue,dentistry faculty,maxillofacial surgery ward</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 5965</telephone>
        <email>mesgarcu@hotmail.com</email>
        <affiliation>Tabriz university of medical sciences,dentistry faculty,maxillofacial surgery ward</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria:all candidates of elective rhinoplasty aged 20-30years &#13;
exclusion criteria:1-patients with systemic diseases 2-history of previous nasal trauma 3-uncooperative patients 4-history of previous nasal surgery 5-patients with inflammation of nasal mucosa 6-patients with severe deformity of nasal dorsum who need complex methods of osteotomy</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T81.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Accidental puncture and laceration during a procedure, not elsewhere classified</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:  after induction of general anesthesia and injection of 10 cc of 1:200000 epinephrine solution at lateral nasal walls and nasal dorsum the surgery was began,3mm osteotome without guard was introduced  through skin at the midway between inner canthus and vestibule. when the  cutting edge of osteotome reached bone the external osteotomy was initiated . In a blinded manner, another investigator used nasal endoscopy to detect nasal mucosal tears and reported them in millimeter (mm).</i_keyword>
      <i_keyword>control group: after induction of general anesthesia and injection of 10 cc of 1:200000 epinephrine solution at lateral nasal walls and nasal dorsum the surgery was began. mucosal incision was made at the lateral nasal wall just above the junction of inferior turbinate.after introduction of 3mm guarded osteotome the internal osteotomy was initiated and completed at the level of the inner canthus . In a blinded manner, another investigator used nasal endoscopy to detect nasal mucosal tears and reported them in millimeter (mm).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of nasal mucosal tear. Timepoint: immediately after intervention(intraoperatively). Method of measurement: indirect view using endoscope.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Amount of bleeding. Timepoint: immediately after completion of osteotomy. Method of measurement: measurment of blood volume (millileter).</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>Investigation secretary of tabriz university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-29</approval_date>
        <contact_name>Tabriz university of medical sciences/ethics committee</contact_name>
        <contact_address>Daneshgah square,daneshgah avenue,Tabriz university of medical sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
