<?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>IRCT201010091138N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-06-07</date_registration>
      <primary_sponsor>Guilan University of Medical Sciences, Vice Chancellor for Research</primary_sponsor>
      <public_title>Effect of radiofrequency tonsillectomy  in recurrent tonsillitis</public_title>
      <acronym></acronym>
      <scientific_title>The results of radiofrequency tonsillectomy compared with conventional cold dissection tonsillectomy in recovery of adults with recurrent tonsillitis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/177</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Chronic Tonsillitis.</hc_freetext>
      <i_freetext>Intervention 1: Surgery will be done under general anesthesia and the operation in control group will be done by standard method of cold dissection tonsillectomy (i.e. dissecting the palatal tonsils from their bed by surgical knife and separating and totally removal of the tonsils from their sites). Duration of operation is measured according to the time, when surgical field is exposed ( after accomplishing the anesthesia ) till the moment that the surgeon is sure that there is no bleeding in the field  of operation.&#13;
At the end of the procedure, the amount of  bleeding is estimated by measuring the blood volume in the vacuum bottle and also by counting the surgical gauzes, used in the operating room during surgery. &#13;
The pain scale after surgery is measured by Visual Analogue Scale from zero to ten centimeters in the 1st, 3rd, 5th and 10th days after surgery &#13;
The patients are asked about taking analgesia after surgery during the afore-mentioned days. &#13;
The patients are also asked about the frequency of tonsillitis &amp; pharyngitis during previous months, and at the same time the faucial tonsils are compared with their pre operation condition according to their size in the 6th, 12th  and 15th months after surgery. Intervention 2: With the patient under general anesthesia and in the Rose&#13;
position, the oropharynx was exposed by use of a Davis gag,&#13;
and bipolar-linear RFITT probe (Celon AG Medical Instruments,&#13;
Teltow/Berlin, Germany) was introduced into the&#13;
crypts of the tonsils. The RF generator working frequency&#13;
was 470 kHz, which was set at 7 W during the procedure.&#13;
The power was constantly controlled by the system, terminating&#13;
the energy application automatically once the thermal&#13;
lesion was created. Five points (i.e., tonsillar crypts,&#13;
including crypts of inferior and superior poles) for grades 1&#13;
and 2 tonsils, seven points for grade 3, and nine points for&#13;
grade 4 tonsils were probed.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Shadman Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralmomenin hospital, 17 shahrivar st.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13 1222 5242</telephone>
        <email>nemati@gums.ac.ir</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Shadman Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralmomenin hospital, 17 shahrivar st.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13 1222 5242</telephone>
        <email>nemati@gums.ac.ir</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
adult patients&#13;
(aged 15-65 years) with recurrent tonsillitis was performed&#13;
in a tertiary referral university hospital that candidated for surgery.  &#13;
Exclusion criteria:&#13;
   Those who had underlying bleeding disorders; who had to use ASA or heparin; those with immunologic disorders.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J35.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic disease of tonsils and adenoids</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>Surgery will be done under general anesthesia and the operation in control group will be done by standard method of cold dissection tonsillectomy (i.e. dissecting the palatal tonsils from their bed by surgical knife and separating and totally removal of the tonsils from their sites). Duration of operation is measured according to the time, when surgical field is exposed ( after accomplishing the anesthesia ) till the moment that the surgeon is sure that there is no bleeding in the field  of operation.&#13;
At the end of the procedure, the amount of  bleeding is estimated by measuring the blood volume in the vacuum bottle and also by counting the surgical gauzes, used in the operating room during surgery. &#13;
The pain scale after surgery is measured by Visual Analogue Scale from zero to ten centimeters in the 1st, 3rd, 5th and 10th days after surgery &#13;
The patients are asked about taking analgesia after surgery during the afore-mentioned days. &#13;
The patients are also asked about the frequency of tonsillitis &amp; pharyngitis during previous months, and at the same time the faucial tonsils are compared with their pre operation condition according to their size in the 6th, 12th  and 15th months after surgery.</i_keyword>
      <i_keyword>With the patient under general anesthesia and in the Rose&#13;
position, the oropharynx was exposed by use of a Davis gag,&#13;
and bipolar-linear RFITT probe (Celon AG Medical Instruments,&#13;
Teltow/Berlin, Germany) was introduced into the&#13;
crypts of the tonsils. The RF generator working frequency&#13;
was 470 kHz, which was set at 7 W during the procedure.&#13;
The power was constantly controlled by the system, terminating&#13;
the energy application automatically once the thermal&#13;
lesion was created. Five points (i.e., tonsillar crypts,&#13;
including crypts of inferior and superior poles) for grades 1&#13;
and 2 tonsils, seven points for grade 3, and nine points for&#13;
grade 4 tonsils were probed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postsurgical pain. Timepoint: on days 1, 3, 5 and 10 after surgery. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Recurrence of tonsillitis/pharyngitis episodes. Timepoint: on months 6, 12 and 15 after surgery. Method of measurement: ask from patient and periodic check-up.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: in the 3rd, 10th and 20th days after surgery. Method of measurement: scale.</sec_outcome>
      <sec_outcome>Intraoperative bleeding. Timepoint: During and end of surgery. Method of measurement: measuring the blood volume in the vacuum bottle and also by counting the surgical gauzes.</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>Guilan University of Medical Sciences, Vice Chancellor for Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2007-06-10</approval_date>
        <contact_name>Ethic committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Siadati st. Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
