<?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>IRCT2013042812294N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-10-21</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Partial Lateral Internal Sphincterotomy Versus Combined Botulinum Toxin A Injection and Topical Application of Diltiazem in Treatment of Chronic Anal Fissure</public_title>
      <acronym></acronym>
      <scientific_title>Partial Lateral Internal Sphincterotomy Versus Combined Botulinum Toxin A Injection and Topical Application of Diltiazem  in treatment of chronic anal fissure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12381</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Chronic Anal Fissure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Under local anesthesia (with lidocaine 5% gel) on left sided or knee elbow position. BTA is injected into the internal anal sphincter on the both sides of anterior midline in equal doses. These patients will be advised to receive 2% DTZ ointment three times daily for six weeks which applied to the perianal region and anus. Intervention 2: Control group: &#13;
under spinal anesthesia in the lithotomy position; internal sphincter muscle fibers were partially &#13;
cut at 3 o’clock position under direct visualization with a transverse incision up to the height of &#13;
the fissure apex using a cautery. In this study, skin tags and hypertrophied anal papillae were also &#13;
removed.</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>Reza Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1136746911, Sina Hospital, Hasanabad Sq.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>heidari.reza1@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences, Medical School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ahmadiamoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1136746911, Sina Hospital, Hasanabad Sq.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 105 5822</telephone>
        <email>ahmadiam@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences, Sina Hospital, Surgery Department</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  diagnosis of chronic anal fissure on  physical  examination  (based  on  having indurations  at  the  edges  and  having  at  least  two  criteria  of  these  three  including  skin  tag; hypertrophied  anal  papillae  and  exposed  internal  sphincter  muscle  fiber)  by  an  experienced &#13;
colorectal surgeon associated with painful defecation for at least 2 month; age between 18 and 100 years old.&#13;
 Exclusion criteria:&#13;
 acute  anal  fissure  (experiencing  symptoms  less  than  two  months);  pregnancy;  secondary anal  fissure;  hypersensitivity  to  DTZ  or  BTA; cardiovascular  disease;  previous  history  of  anal surgery;  atypical  fissure  and  chronic  headache.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K60.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic Anal Fissure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Under local anesthesia (with lidocaine 5% gel) on left sided or knee elbow position. BTA is injected into the internal anal sphincter on the both sides of anterior midline in equal doses. These patients will be advised to receive 2% DTZ ointment three times daily for six weeks which applied to the perianal region and anus.</i_keyword>
      <i_keyword>Control group: &#13;
under spinal anesthesia in the lithotomy position; internal sphincter muscle fibers were partially &#13;
cut at 3 o’clock position under direct visualization with a transverse incision up to the height of &#13;
the fissure apex using a cautery. In this study, skin tags and hypertrophied anal papillae were also &#13;
removed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Wound healing. Timepoint: one week, 1,2,6 and 12 months postoperatively. Method of measurement: Complete Wound Healing (macroscopic epithelialization).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications. Timepoint: , one week, 1,2,6,12 months postoperatively. Method of measurement: physical examination and history taking, VAS.</sec_outcome>
      <sec_outcome>Induration, hypertrophied papilla, exposing internal anal sphincter,skin tag. Timepoint: before and after surgery. Method of measurement: physical examination.</sec_outcome>
      <sec_outcome>Pain. Timepoint: before treatment, 1 week, 1,2,6 and 12 months postoperatively. Method of measurement: visual analog scale.</sec_outcome>
      <sec_outcome>Chronicity of fissure. Timepoint: before treatment. Method of measurement: history taking.</sec_outcome>
      <sec_outcome>Fissure localization. Timepoint: before treatment. Method of measurement: physical examination.</sec_outcome>
      <sec_outcome>Bleeding. Timepoint: before treatment, 1 week, 1,2,6 and 12 months postoperatively. Method of measurement: history taking.</sec_outcome>
      <sec_outcome>Pain at night. Timepoint: before treatment, 1 week, 1,2,6 and 12 months postoperatively. Method of measurement: history taking.</sec_outcome>
      <sec_outcome>Recurrence. Timepoint: 1 ,2,6 and 12 month postoperatively. Method of measurement: history taking and physical 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>Vice chancellor for research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-09-16</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences.</contact_name>
        <contact_address>1136746911, Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
