<?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>IRCT2014022816773N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-19</date_registration>
      <primary_sponsor>Yazd Shahid Sadoughi University of Medical Sciences</primary_sponsor>
      <public_title>compare of hemorrhoidectomy complications in conventional and ligasure technique</public_title>
      <acronym></acronym>
      <scientific_title>the evaluation of early and late hemorrhoidectomy complications in  conventional and ligasure technique</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>101</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15589</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Haemorrhoid.</hc_freetext>
      <i_freetext>Intervention 1: LigaSure hemorrhoidectomy: The patients are anesthetized general or spinal. Position is lithotomy. We use disposable thyroid LigaSure from Covidien Company with the size of 17 cm and its grade of temperature is 2. By using great retractor during surgery LigaSure forceps lay on vascular pedicle level and scissor tissue cut coagulated line. We do not transfixation and it left open. Finally we insert hemostasis sponge in to anal canal. Intervention 2: The patients are anesthetized general or spinal. Position is lithotomy. By using great retractor during surgery we incise hemorrhoidal pile above the dentate line with scissor tissue. With blunt dissection internal sphincter muscle separated from hemorrhoidal pile. With absorbable cotton, pile transfixes and cut and also Hemostasis is achieved.  It left open in open technique and repairs with absorbable cotton in close technique.  Finally we insert hemostasis sponge in to anal canal.</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 Mohammad Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd Shahid Sadoughi Hospital</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1822 4000</telephone>
        <email>mohammadzare85©yahoo.com</email>
        <affiliation>Yazd Shahid Sadoughi University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naeimeh Heiranizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd Shahid Sadoughi university of medical science Pardis,  Shohadaye Gomnam Blvd, Prof. Hesabi Blvd.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1822 4000</telephone>
        <email>Naeimeh_heiranizedeh©ssu.ac.ir</email>
        <affiliation>Yazd Shahid Sadoughi university of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patiens in our literature have grade III,IV symptomatic  internal hemorrhoid that need to surgery in shahid sadoughi hospital in 1390_91. patients whome had anorectal disease ago , have others anorectal diseases,recurrence hemorrhoid and dont want to attand delete from this study.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Haemorrhoids</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>LigaSure hemorrhoidectomy: The patients are anesthetized general or spinal. Position is lithotomy. We use disposable thyroid LigaSure from Covidien Company with the size of 17 cm and its grade of temperature is 2. By using great retractor during surgery LigaSure forceps lay on vascular pedicle level and scissor tissue cut coagulated line. We do not transfixation and it left open. Finally we insert hemostasis sponge in to anal canal.</i_keyword>
      <i_keyword>The patients are anesthetized general or spinal. Position is lithotomy. By using great retractor during surgery we incise hemorrhoidal pile above the dentate line with scissor tissue. With blunt dissection internal sphincter muscle separated from hemorrhoidal pile. With absorbable cotton, pile transfixes and cut and also Hemostasis is achieved.  It left open in open technique and repairs with absorbable cotton in close technique.  Finally we insert hemostasis sponge in to anal canal.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The post operation pain. Timepoint: Every day until 28nd day, after a week, after a month, after six month and after one year. Method of measurement: In terms of Numeral Pain Score.</prim_outcome>
      <prim_outcome>Bleeding during operation. Timepoint: Only during the operation. Method of measurement: The number of blood Gauze.</prim_outcome>
      <prim_outcome>The time of operation. Timepoint: During operation. Method of measurement: In minutes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The time of returne to work. Timepoint: a week, a month, six month and 12 month. Method of measurement: Questioner and face to face in days.</sec_outcome>
      <sec_outcome>Pain score. Timepoint: a week, a month, six month and one year. Method of measurement: numeral pain score with questionare and face to face.</sec_outcome>
      <sec_outcome>Anal stenisis. Timepoint: numeral pain score. Method of measurement: PH/E, HX (DRE).</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>Yazd Shahid Sadoughi University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-11-28</approval_date>
        <contact_name>shahid sadoughi university of medical sciences</contact_name>
        <contact_address>Shahid Bahonar Square, Shahid sadoughi street, central building Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
