<?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>IRCT20230812059129N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-02</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>comparison of results following septorhinoplasty with modified swing door (before and after clinical trial)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of results following septorhinoplasty with modified swing door (before and after clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71998</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>nasal septal deviation.</hc_freetext>
      <i_freetext>Intervention group: First, photographs are taken of the patients before the operation. Septoplasty is performed by a surgeon on patients with a new method. In this technique, all rhinoplasty surgeries are performed under general anesthesia and open surgery technique is used for better access to the septum. The skin flap of the dorsum of the nose is raised. In the midline, the middle and medial domes and coruras as well as the upper lateral cartilages are separated from the septum and an excellent access to the septum is achieved. Submucoperichondral flaps are raised bilaterally. In patients with cartilaginous or bony hump, the bony hump is removed with the help of a rasp and the cartilaginous hump is removed with a No. 15 blade. l-strut is prepared with a No. 15 blade so that its caudal edge is at a distance of ten mm from the caudal edge of the septum and its lateral edge is at a distance of 20 mm from the lateral edge of the septum. The cartilaginous clamp is harvested from the caudal part of the dorsal incision and in the vicinity of the bony septum. Then, an incision is made parallel to the transverse surface of the septum and at a distance of 10 mm from it, from the caudal septum (Heidarizadeh incision), which determines the length of this incision, the location and the amount of deviation of the septum. The cartilage clamp harvested in the previous stage is placed vertically between the two horizontal parts created as a result of Heidarizadeh incision, without any additional maneuvers, and separates the two parts of the septum in the area of ​​the tip of the nose like a wedge. The cephalocaudal position of this grip is also dependent on the severity of the deviation and the amount of correction required. For the plastic type, after cephalic resection, transdome and interdome sutures are applied; The columellar strut is placed, and then a 2mm thick and 7mm wide cap is placed in the area of ​​the dome (the distance between the tip defining points). Finally, diced cartilage is placed and osteotomy is performed externally. If needed, alarplasty is performed in the usual way by resection of a wedge-like area and the area is sutured with 0-6 nylon thread. An intranasal splint is used for one week. Extranasal splint remains in the area for one week. Three months after the surgery, photographs are taken of the patients..</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:
The results of analyzes and data of each patient are accessible

When:
A year after the publication of the article

To whom:
Academic researchers and reviewers of medical journals

Conditions:
Any analysis on the data of each patient is allowed, but it should be done by referees of medical journals

Where to obtain:
The author and journal published the article

How to obtain:
The email will be given to the author or the publishing journal and the information will be sent shortly.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Heidarizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of dentistry, Arak University of Medical Sciences, in front of Madar park, Golestan Quarter, Mostafa Khomeini st.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819737447</zip>
        <telephone>+98 912 032 9564</telephone>
        <email>heidarizadeh@ajums.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Heidarizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of dentistry, Arak University of Medical Sciences, in front of Madar park, Golestan Quarter, Mostafa Khomeini st.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819737447</zip>
        <telephone>+98 912 032 9564</telephone>
        <email>heidarizadeh@ajums.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients over 18 years old
Suffering from nasal deformity and deviation in the septum
Rhinoplasty applicant
No cancer
The absence of diabetes, cardiovascular problems and immune system defects</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of previous rhinoplasty</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, photographs are taken of the patients before the operation. Septoplasty is performed by a surgeon on patients with a new method. In this technique, all rhinoplasty surgeries are performed under general anesthesia and open surgery technique is used for better access to the septum. The skin flap of the dorsum of the nose is raised. In the midline, the middle and medial domes and coruras as well as the upper lateral cartilages are separated from the septum and an excellent access to the septum is achieved. Submucoperichondral flaps are raised bilaterally. In patients with cartilaginous or bony hump, the bony hump is removed with the help of a rasp and the cartilaginous hump is removed with a No. 15 blade. l-strut is prepared with a No. 15 blade so that its caudal edge is at a distance of ten mm from the caudal edge of the septum and its lateral edge is at a distance of 20 mm from the lateral edge of the septum. The cartilaginous clamp is harvested from the caudal part of the dorsal incision and in the vicinity of the bony septum. Then, an incision is made parallel to the transverse surface of the septum and at a distance of 10 mm from it, from the caudal septum (Heidarizadeh incision), which determines the length of this incision, the location and the amount of deviation of the septum. The cartilage clamp harvested in the previous stage is placed vertically between the two horizontal parts created as a result of Heidarizadeh incision, without any additional maneuvers, and separates the two parts of the septum in the area of ​​the tip of the nose like a wedge. The cephalocaudal position of this grip is also dependent on the severity of the deviation and the amount of correction required. For the plastic type, after cephalic resection, transdome and interdome sutures are applied; The columellar strut is placed, and then a 2mm thick and 7mm wide cap is placed in the area of ​​the dome (the distance between the tip defining points). Finally, diced cartilage is placed and osteotomy is performed externally. If needed, alarplasty is performed in the usual way by resection of a wedge-like area and the area is sutured with 0-6 nylon thread. An intranasal splint is used for one week. Extranasal splint remains in the area for one week. Three months after the surgery, photographs are taken of the patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Objective comparison of angles with deviation of anthropometric parameters. Timepoint: 3-months after surgery. Method of measurement: Face photographs.</prim_outcome>
      <prim_outcome>Evaluation of nasal deformity before and after septorhinoplasty. Timepoint: 3-months after surgery. Method of measurement: MiRa standard scale.</prim_outcome>
      <prim_outcome>Evaluation of patient satisfaction after septorhinoplasty. Timepoint: 3-months after surgery. Method of measurement: Rhinoplasty Outcome Evaluation (ROE) scale.</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>-</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-04</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Sardasht Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
