<?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>IRCT20230107057071N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-16</date_registration>
      <primary_sponsor>Ilam University of Medical Sciences</primary_sponsor>
      <public_title>SURGERY DURATION, WOUND HEALING PROCESS AND COMPLICATIONS OF BIPOLAR ELECTROCAUTERY DISSECTION VERSUS COLD DISSECTION TONSILLECTOMY IN ADULTS.</public_title>
      <acronym></acronym>
      <scientific_title>SURGERY DURATION, WOUND HEALING PROCESS AND COMPLICATIONS OF BIPOLAR ELECTROCAUTERY DISSECTION VERSUS COLD DISSECTION TONSILLECTOMY IN ADULTS.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67886</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The participants will not know which of the left or right tonsils will be operated on by Bipolar Electrocautery or Cold dissection.
Those responsible for data collection will not know which of the left or right tonsils was operated by bipolar electrocautery or cold dissection.
The data analysts will not know which of the left or right tonsils was operated by bipolar electrocautery or cold dissection.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tonsillectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Bipolar Electrocautery method will be used to remove the palatal tonsil on one side (for example, the right palatine tonsil). In this method, the incision will be made by bipolar forceps and the tonsil will be separated with forceps. Then the bleeding will be controlled by electrocoagulation. Intervention 2: Control group: To remove the palatine tonsil on the other side (for example, the left side), the Cold Dissection method will be used. In this method, the tonsil will be separated from its bed by a scalpel cut and removed with forceps. Then the bleeding will be controlled by suturing.</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>Meysam Jahanbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ilam University of Medical Sciences; Banganjab; Pazhuhesh Blvd</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6939177143</zip>
        <telephone>+98 914 755 4043</telephone>
        <email>meysam.j17@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Meysam Jahanbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ilam University of Medical Sciences; Banganjab; Pazhuhesh Blvd</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6939177143</zip>
        <telephone>+98 914 755 4043</telephone>
        <email>meysam.j17@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Need to perform tonsillectomy
Age range above 18 years
Consent to study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a preoperative infection
Bleeding diseases and any disorders in coagulation tests
Mental retardation
underlying diseases (diabetes, malignancy, severe asthma, sickle cell anemia, etc.)
Failure to complete the forms
Lack of cooperation after the operation</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: Bipolar Electrocautery method will be used to remove the palatal tonsil on one side (for example, the right palatine tonsil). In this method, the incision will be made by bipolar forceps and the tonsil will be separated with forceps. Then the bleeding will be controlled by electrocoagulation.</i_keyword>
      <i_keyword>Control group: To remove the palatine tonsil on the other side (for example, the left side), the Cold Dissection method will be used. In this method, the tonsil will be separated from its bed by a scalpel cut and removed with forceps. Then the bleeding will be controlled by suturing.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of bleeding during surgery. Timepoint: After the end of the surgical procedure. Method of measurement: By measuring the amount of suctioned blood in the graduated suction minus the suctioned serum.</prim_outcome>
      <prim_outcome>Duration of surgery. Timepoint: After the end of the surgical procedure. Method of measurement: The duration of the surgery from the moment of cutting to the moment of complete control of bleeding will be recorded by a timer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The severity of sore throat. Timepoint: 24 hours, day 8, day 15, and day 22 after tonsillectomy. Method of measurement: Using the Visual Analogue Scale.</sec_outcome>
      <sec_outcome>The severity of earache. Timepoint: 24 hours, day 8, day 15, and day 22 after tonsillectomy. Method of measurement: Using the Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Number of bleeding episodes after surgery. Timepoint: Within 22 days after surgery. Method of measurement: Based on the patient's complaint within 22 days after surgery and also examination by the doctor at 24 hours, 8 days, 15 days, and 22 days after tonsillectomy.</sec_outcome>
      <sec_outcome>The percentage of pseudomembrane formed. Timepoint: 24 hours, day 8, day 15, and day 22 after tonsillectomy. Method of measurement: Macroscopically by the doctor's examination.</sec_outcome>
      <sec_outcome>The percentage of absorbed pseudomembrane. Timepoint: 24 hours, day 8, day 15, and day 22 after tonsillectomy. Method of measurement: Macroscopically by the doctor's examination.</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>Ilam University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-19</approval_date>
        <contact_name>Ethics committee of Ilam University of Medical Sciences</contact_name>
        <contact_address>Ilam University of Medical Sciences; Banganjab; Pazhuhesh Blvd Ilam Ilam Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
