<?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>IRCT20220903055866N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-20</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>comparison of the effect of two low to high lateral osteotomy methods, percutaneous and internal on the tear trough and scleral show in patients undergoing esthetic open rhinoplasty(a randomized clinical trial)</public_title>
      <acronym></acronym>
      <scientific_title>comparison of the effect of two low to high lateral osteotomy methods, percutaneous and internal on the tear trough and scleral show in patients undergoing esthetic open rhinoplasty(a randomized clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65676</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Single blind RCT. The 110 envelopes with names A &amp; B were given to patients before surgery. The patient before surgery ,every one picked up one of them
A: Percutaneous ; B: Internal.</study_design>
      <phase>N/A</phase>
      <hc_freetext>comparison of the effect of two low to high lateral osteotomy methods, percutaneous and internal.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: internal osteotomy; internal osteotomy will be performed with a left and right lateral osteotome , by cutting the nasal mucosa in the pyriform opening and creating a subperiosteal tunnel in the osteotomy line, maintaining Webster's triangle up to the intercanthal line(L to H) method. inner dressing will be placed for 24 hours .External Splints for 7 days and recommended ice pack for 24 hours. Intervention 2: Intervention group: percutaneous osteotomy; approach: skin incision with stab incision. Osteotomy with 2mm osteotome and preservation of Webster Triangle. osteotomy by multi puncture and stamp-postage (L to h) bilaterally. inner dressing will be placed for 24 hours .External Splints for 7 days and recommended ice pack for 24 hours.</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 The assistant professor has not given an opinion to broadcast this information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Raziyeh Moarefpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karoon sharghi</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6136711885</zip>
        <telephone>+98 918 348 2684</telephone>
        <email>maryammoaref@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ershad Hemmati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Soroush Ave, Kianpars, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6136711885</zip>
        <telephone>+98 61 3337 8489</telephone>
        <email>hemmati1984@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient satisfaction
Patients over 18 years old
No contraindications for rhinoplasty surgery
narrow bridge width of the nose
People who are systemically healthy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1-graves ophthalmopathy (thyroid eye disease)
People who have already undergone nose surgery
People who were suffering from chronic diseases
People who have undergone other interventions such as neck ,face lift or blepharoplasty
history of fracture and trauma to the nose and face
History of zygoma bone fracture and naso-orbital-ethmoid (NOE) FX
People with endocrine diseases, vasculitis or infections around the eyes
People with a prominent lacrimal bone edge  ( sunken globe )
History of burns (chemical, thermal, electrical, etc.) on the face and around the eyes.
Clear eyelid drooping with excess skin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: internal osteotomy; internal osteotomy will be performed with a left and right lateral osteotome , by cutting the nasal mucosa in the pyriform opening and creating a subperiosteal tunnel in the osteotomy line, maintaining Webster's triangle up to the intercanthal line(L to H) method. inner dressing will be placed for 24 hours .External Splints for 7 days and recommended ice pack for 24 hours</i_keyword>
      <i_keyword>Intervention group: percutaneous osteotomy; approach: skin incision with stab incision. Osteotomy with 2mm osteotome and preservation of Webster Triangle. osteotomy by multi puncture and stamp-postage (L to h) bilaterally. inner dressing will be placed for 24 hours .External Splints for 7 days and recommended ice pack for 24 hours</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tear trough size changes. Timepoint: 1 , 3 months after surgery. Method of measurement: Sonography device Iexplorer (sonic S) with linear probe. High resolution of 75 micrometers and with a frequency of 10 MHz. Tissue depth in millimeter dimensions.</prim_outcome>
      <prim_outcome>Scleral show. Timepoint: 1 , 3 months after surgery. Method of measurement: Photos were taken using a digital SLR camera (Canon 45OD EOS) and scleral show area was measured with Adobe CS5 Ph software. The unit is Mm2.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-23</approval_date>
        <contact_name>Ethics committee of Jundi Shapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Karoon Sharghi Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
