<?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>IRCT20080820001056N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-12</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>comparison between Nylon versus PDS  in Tongue-in-groove technique in rhinoplasty</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between  Nylon and PDS suture for development and maintenance of rotation and projection in Tongue-in-groove technique rhinoplasty on rhinoplasty patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42198</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: with block randomization of size 4 ,the patients were placed in 2 groups of A and B.In one group Nylon suture and in other group PDS suture was uesd.The blocks were developed by epidemiologist with one code for each patient was considered to assign in A or B group, Blinding description: The epidemiologist was the only person who knows randomization code. The surgeon will not know about the suture material types until the end of surgery. The surgeon assistant will let him know suture material types at the end of surgery during TIG. The surgeon assistant will be blinded about suture material before surgery and patients won't know suture materials were used during their surgeries.</study_design>
      <phase>3</phase>
      <hc_freetext>Rhinoplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: using Nylon 5-0 Suture(ethicon company) in TIG Technique. only one suture was used.Nasal tip projection measurements by Goode's ratio method and Nasal tip rotation measurements by nasolabial angel is done before intervention visit and 1,6,12 months after intervention visit by performing standard photography and photo analysis with photoshop .also checking the Patient's Satisfaction of Rhinoplasty by Visual Analogue Scale in visits of 1,6,12 months after intervention and checking nasal function before intervention visit and 12 months after intervention visit with SCHNOS. Intervention 2: Intervention group: 2 ,using PDS 5-0 Suture( ethicon company). in TIG Technique.only one suture was used.Nasal tip projection measurements by Goode's ratio method and Nasal tip rotation measurements by nasolabial angel is done before intervention visit and 1,6,12 months after intervention visit by performing standard photography and photo analysis with photoshop .also checking the Patient's Satisfaction of Rhinoplasty by Visual Analogue Scale in visits of 1,6,12 months after intervention and checking nasal function before intervention visit and 12 months after intervention visit with SCHNOS.</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:
we will publish it in article

When:
we will publish it in article 2020

To whom:
nobody can have anything more than article

Conditions:
we will publish it article but nobody can have access to other data

Where to obtain:
we will publish it in article

How to obtain:
Contact with researchers

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Babak Saedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Keshavars BLV ,Imama khomainee hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 2270 0765</telephone>
        <email>saedi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Babak saedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Keshavars BLV ,Imam khomainee Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 2270 0765</telephone>
        <email>saedi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients enrolled in open rhinoplasty and it was possible to perform TIG</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>congenital anomalies
severe septal deviation
severe nasal bone deviation
hypersensitivity to material used in surgery
revision surgery</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 1: using Nylon 5-0 Suture(ethicon company) in TIG Technique. only one suture was used.Nasal tip projection measurements by Goode's ratio method and Nasal tip rotation measurements by nasolabial angel is done before intervention visit and 1,6,12 months after intervention visit by performing standard photography and photo analysis with photoshop .also checking the Patient's Satisfaction of Rhinoplasty by Visual Analogue Scale in visits of 1,6,12 months after intervention and checking nasal function before intervention visit and 12 months after intervention visit with SCHNOS</i_keyword>
      <i_keyword>Intervention group: 2 ,using PDS 5-0 Suture( ethicon company). in TIG Technique.only one suture was used.Nasal tip projection measurements by Goode's ratio method and Nasal tip rotation measurements by nasolabial angel is done before intervention visit and 1,6,12 months after intervention visit by performing standard photography and photo analysis with photoshop .also checking the Patient's Satisfaction of Rhinoplasty by Visual Analogue Scale in visits of 1,6,12 months after intervention and checking nasal function before intervention visit and 12 months after intervention visit with SCHNOS</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nasal tip projection. Timepoint: Nasal tip projection measurements before intervention and 1,6,12 months after intervention. Method of measurement: Goode's ratio.</prim_outcome>
      <prim_outcome>Nasal tip rotation. Timepoint: Nasal tip rotation measurements before intervention and 1,6,12 months after intervention. Method of measurement: nasolabial angle.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient's Satisfaction of Rhinoplasty. Timepoint: 1,6,and 12 months after surgery. Method of measurement: Visual Analogue Scale(VAS).</sec_outcome>
      <sec_outcome>Nasal Function. Timepoint: Before and 1 year after surgery. Method of measurement: Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) scale.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-26</approval_date>
        <contact_name>ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No 1068,First Enterance,Block 5,Ekbatan town tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
