<?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>IRCT20221002056073N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-18</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The success rate of two surgical approaches of Tympanoplasty</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of endoscopic ear surgery compared to microscopic method on pain severity and graft success rate among patients with chronic otitis media: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70787</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Allocation of patients will be done by simple randomization according to computerized generated numbers using random allocation software that half of the participants will be assigned to the endoscopy group based on odd numbers and the other half will be assigned to the microscopic group based on even numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Otitis media.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In the microscopy group (a common approach) the Opmi Vario S88 microscope from Carl Zeiss in Oberkochen, Germany will be used for investigation. In the microscopic approach, an incision will be executed behind the ear with subsequent entry into the canal. The Lempert method will be served as the basis for the lifting of the tympanomeatal flap. Intervention 2: Intervention group 2: The endoscopic group (the new approach) will be employed an endoscopic system manufactured by Karl Storz in Tuttlingen, Germany. Rigid endoscopes with either 0- or 30-degree angles and diameters of 3.0- or 4.0-mm, and lengths of 11 or 16 cm (also from Karl Storz) will be used for the procedure. The incisions for this approach will be made in the posterior part of the EAC approximately 5 to 6 mm lateral to tympanic annulus, perpendicular to the TM tympanic at both the superior and the inferior ends of the first incision.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Samarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Educational Hospital, Ershad Ave., Modarres Blvd.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715781351</zip>
        <telephone>+98 44 3345 9538</telephone>
        <email>samareireza@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Samarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Educational Hospital, Ershad Ave., Modarres Blvd.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715781351</zip>
        <telephone>+98 44 3345 9538</telephone>
        <email>samareireza@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patients with a mucoid type of chronic suppurative otitis media
Presence of conductive hearing loss with no sensorineural hearing loss in patients
Patients with good general physical condition
Patients with no evidence of infection in nose
Patients with throat and paranasal sinuses undergoing surgery for the first time for the concerned ear</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals younger than14 years of age and older than 55 years
Smokers
Participants with contralateral ear disease
Patients with cholesteatoma
Patients with otosclerosis
Patients with tympanosclerotic plaque or granulation tissue in the middle ear
Patients undergoing simultaneous mastoid surgery
Revision cases and associated poor general condition
Those with preoperative medical issues such as asthma
Diabetic patients
Patients with cardiovascular disease
Patients with chronic liver or renal diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H65.20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic serous otitis media</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In the microscopy group (a common approach) the Opmi Vario S88 microscope from Carl Zeiss in Oberkochen, Germany will be used for investigation. In the microscopic approach, an incision will be executed behind the ear with subsequent entry into the canal. The Lempert method will be served as the basis for the lifting of the tympanomeatal flap.</i_keyword>
      <i_keyword>Intervention group 2: The endoscopic group (the new approach) will be employed an endoscopic system manufactured by Karl Storz in Tuttlingen, Germany. Rigid endoscopes with either 0- or 30-degree angles and diameters of 3.0- or 4.0-mm, and lengths of 11 or 16 cm (also from Karl Storz) will be used for the procedure. The incisions for this approach will be made in the posterior part of the EAC approximately 5 to 6 mm lateral to tympanic annulus, perpendicular to the TM tympanic at both the superior and the inferior ends of the first incision.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Graft success rate. Timepoint: The graft success rate will be assessed between 3-6 months postoperatively. Method of measurement: Endoscopic assessment.</prim_outcome>
      <prim_outcome>Pain severity. Timepoint: Pain severity will be assessed immediately after surgery and one day after surgery. Method of measurement: Pain severity will be evaluated and recorded by the patient using an 11-point numerical rating scale (NRS-11, range 0 to 10).</prim_outcome>
      <prim_outcome>Duration of surgery. Timepoint: The duration of the surgery will be measured intraoperatively. Method of measurement: Using a chronometer (in minute).</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-15</approval_date>
        <contact_name>Research Ethics Committees of Urmia University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini Educational Hospital, Ershad Ave., Ayatollah Modarres Blvd. Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
