<?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>IRCT2015041314483N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-21</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Phenytoin ointment in healing anal fistula after surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between topical phenytoin 1% and placebo locally to reduce postoperative pain and recovery time for patients with perianal fistula after fistulotomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14106</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anal fistula.</hc_freetext>
      <i_freetext>Intervention 1: All patients treated by probing fistula tract in lithotomy position under spinal anesthesia. Then direction is probe guided and fistulotomy done in its length and preserve sphincter muscles involved in CONTINENCY. then bed of wound currete  to remove epithelial lining. Patients are hospitalized for a day. the Topical cream phenytoin 1% used to 2 times a day. for all patients prescribed an oral NSAIDS. Intervention 2: All patients treated by probing fistula tract in lithotomy position under spinal anesthesia. Then direction is probe guided and fistulotomy done in its length and preserve sphincter muscles involved in CONTINENCY. then bed of wound currete to remove epithelial lining. Patients are hospitalized for a day. the Topical placebo used to 2 times a day. for all patients prescribed an oral NSAIDS.</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></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.M.Alvandipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital of Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3336 1700</telephone>
        <email>malvandipour@mazums.ac.ir</email>
        <affiliation>Mazandaran University of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Exclusion criteria included:  Long-term use of corticosteroids ;diabetes POORLY CONTROL ;TB patients; people with Coron disease; people with underlying malignancy;patients who have had radiation; patients with a history cemotherapy less than 2 weeks; allergy to phenytoin. &#13;
Inclusion criteria: all patients with anal fistula.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K60.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anal fistula</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>All patients treated by probing fistula tract in lithotomy position under spinal anesthesia. Then direction is probe guided and fistulotomy done in its length and preserve sphincter muscles involved in CONTINENCY. then bed of wound currete  to remove epithelial lining. Patients are hospitalized for a day. the Topical cream phenytoin 1% used to 2 times a day. for all patients prescribed an oral NSAIDS.</i_keyword>
      <i_keyword>All patients treated by probing fistula tract in lithotomy position under spinal anesthesia. Then direction is probe guided and fistulotomy done in its length and preserve sphincter muscles involved in CONTINENCY. then bed of wound currete to remove epithelial lining. Patients are hospitalized for a day. the Topical placebo used to 2 times a day. for all patients prescribed an oral NSAIDS</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound healing. Timepoint: 2,4,6 weeks after surgery. Method of measurement: physical exam.</prim_outcome>
      <prim_outcome>Fecal and gas incontinency. Timepoint: 2,4,6 weeks after surgery. Method of measurement: wexner questioner.</prim_outcome>
      <prim_outcome>Post operative pain. Timepoint: 2,4,6 weeks after surgery. Method of measurement: SELFE RELATED ON A VISUAL ANALOG SCALE.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anal pruritus. Timepoint: 2,4,6 weeks after surgery. Method of measurement: 5-D Pruritus Scale.</sec_outcome>
      <sec_outcome>Wound secretion. Timepoint: 2,4,6 weeks after surgery. Method of measurement: physical exam.</sec_outcome>
      <sec_outcome>Pain during defecation. Timepoint: 2,4,6 weeks after surgery. Method of measurement: SELFE RELATED ON A VISUAL ANALOG SCALE.</sec_outcome>
      <sec_outcome>Post operative complications. Timepoint: 2,4,6 weeks after surgery. Method of measurement: physical exam.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-21</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Mazandaran University of Medical Sciences, beginning Valiasr Highway, Jouybar three way,Imam Khomeini square,Sari,Iran Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
