<?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>IRCT20260530069575N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-02</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Tonsillectomy Outcomes Using LigaSure Device-Assisted Technique  Versus Conventional  Method</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Tonsillectomy Outcomes Using LigaSure Device-Assisted Technique  Versus Conventional  Method</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/90486</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be performed using the random blocking method (four-block blocks). The possible blocks are as follows: 1- AABB, 2- ABAB, 3- BABA, 4- BBAA, 5- BAAB, 6- ABBA. At this stage, numbers (1 to 6) will be randomly selected using a random number table, and this process will be repeated 15 times until the sample size is reached, Blinding description: Patients do not know which group they have been assigned to, but they were informed about both methods beforehand and entered the study with full consent. Since they are under anesthesia, they are unaware of how their surgery was performed. Additionally, the outcome assessor and the data analyst are blinded to the study hypothesis.</study_design>
      <phase>3</phase>
      <hc_freetext>Tonsillectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: onsillectomy surgery is performed using LigaSure. LigaSure is a new electrosurgical hemostatic device consisting of an electrosurgical generator, a handpiece with a forceps‑like scissor mechanism, along with a manual or foot switch. Intervention 2: Control group: Tonsillectomy is performed using cold dissection. In this method, the tonsil and its capsule are separated from the surrounding tissues using a dissector, detached from the lower pole, and the tonsil is removed. Hemostasis is achieved using 3/0 Vicryl suture.</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 Due to patient confidentiality and privacy considerations, we have not received permission from the ethics committee to share individual patient data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ismail Al- Habash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>baqiatala university south sheikh baha st, molasadra, st , vanak sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 5511</telephone>
        <email>alhabash-ismail@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jaleh Yusefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrati Alley, Sheykh Bahaei st, Mollasadra st., Vanaq sq., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8862 0826</telephone>
        <email>yousefi.jaleh@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients older than 3 years and younger than 16 years who
candidates for tonsillectomy surgery
have provided consent for the procedure
Patients that undergoing tonsillectomy for the first time.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have a history of incomplete tonsil surgery
have coagulation disorders
withdraw from continued cooperation during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J35.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertrophy of tonsils</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: onsillectomy surgery is performed using LigaSure. LigaSure is a new electrosurgical hemostatic device consisting of an electrosurgical generator, a handpiece with a forceps‑like scissor mechanism, along with a manual or foot switch.</i_keyword>
      <i_keyword>Control group: Tonsillectomy is performed using cold dissection. In this method, the tonsil and its capsule are separated from the surrounding tissues using a dissector, detached from the lower pole, and the tonsil is removed. Hemostasis is achieved using 3/0 Vicryl suture.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity at the surgical site (pharynx) based on the Visual Analogue Scale (VAS). Timepoint: 24 hours, 3 and 7 days after surgery. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Bleeding during operation. Timepoint: During surgery. Method of measurement: The volume of blood loss is calculated by counting the bloody gauzes (each saturated gauze = 15 mL) and collecting the blood in a graduated suction during the procedure, and is recorded in milliliters.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Operation Time. Timepoint: The time from the start of surgery (the first contact of the instrument with the tissue) until the completion of incision and bleeding control is recorded with a chronometer and reported in seconds or minutes. Method of measurement: During operation.</sec_outcome>
      <sec_outcome>Infection. Timepoint: 24 hours, 3 and 7 days after surgery. Method of measurement: Occurrence of an inflammatory response or local or systemic infection in the surgical area, characterized by symptoms such as fever, purulent discharge, foul odor, or redness.</sec_outcome>
      <sec_outcome>Secondary Bleeding. Timepoint: 24 hours, 3 and 7 days after surgery. Method of measurement: Observation of obvious bleeding from the mouth or nose (spitting blood, hematemesis).</sec_outcome>
      <sec_outcome>Posterior pillar injury. Timepoint: 7 days after surgery. Method of measurement: Direct visual inspection: After removing the tonsil, the surgeon carefully examines the tonsillar fossa and both the anterior and posterior pillars using a retractor or speculum.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-03-18</approval_date>
        <contact_name>Ethics Commmittee of Baqiyatallah Hospital</contact_name>
        <contact_address>Baqiyatallah university, south sheikh bahai st, molasdra st, vanak sq Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
