<?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>IRCT20170316033094N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-11</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Cartilage graft for correction of nasal septum deviation</public_title>
      <acronym></acronym>
      <scientific_title>The correction of nasal septal deviations in rhinoplasty: a novel approach using swing door technique with and without cartilage graft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59231</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups  using the block randomization method with the following sequences: AABB, ABAB, ABBA, BAAB, and BABA. Group A undergoes the swing door without cartilage graft, and group B swing door with cartilage graft. 
Concealment will carried out using pocket concealment, Blinding description: The patient will blind about the group of intervention. Due to the finding assessment will performed after surgery and the method applied is not detectable after surgery hence outcome assessor is automatically blinded regarding the group f intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Deviated nasal septum.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The surgical procedure performed under general anesthesia and one or more batten grafts made of septal cartilage  is interposed between the cut ends of the caudal L-strut and then sutured. After surgery medications and follow-up are the same in both groups and are those routinely conducted in septoplasty. Intervention 2: Control group: The surgical procedure performed under general anesthesia and deviated septum  is interposed only using swing door technique without graft. After surgery medications and follow-up are the same in both groups and are those routinely conducted in septoplasty.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Heidarizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>drmehdiheidarizadehomfs@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Heidarizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ِDentistry Faculty, Arak University of Medical SciencesA'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>drmehdiheidarizadehomfs@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Nasal septum deviation
Patient's satisfaction for participation
Age between 18-50 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug allergies
Respiratory diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Deviated nasal septum</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: The surgical procedure performed under general anesthesia and one or more batten grafts made of septal cartilage  is interposed between the cut ends of the caudal L-strut and then sutured. After surgery medications and follow-up are the same in both groups and are those routinely conducted in septoplasty.</i_keyword>
      <i_keyword>Control group: The surgical procedure performed under general anesthesia and deviated septum  is interposed only using swing door technique without graft. After surgery medications and follow-up are the same in both groups and are those routinely conducted in septoplasty.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nasal septum deviation. Timepoint: 1 month after surgery. Method of measurement: Vertical perpendicular line on line connecting pupils.</prim_outcome>
      <prim_outcome>Patient's satisfaction. Timepoint: 1 month after surgery. Method of measurement: visual analogue scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Not applicable. Timepoint: -. Method of measurement: -.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-30</approval_date>
        <contact_name>Research Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Research and Technology Deputy of Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
