<?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>IRCT20210919052515N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-20</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the two methids of conventional internal partial sphincterotomy and tailored sphincterotomy of string suture anoscope in  chronic anal fissure surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the results of chronic anal fissure surgery between conventional internal partial sphincterotomy and tailored sphincterotomy of string suture anoscope</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83962</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two methods of surgery using block randomization based on generated numbers by random allocation software. So that, in this software, the number of groups and the total number of the sample size will be entered  and then in the block section, the block randomization method will be implemented. Patients will be allocated to two groups based on generated numbers, Blinding description: The study will be conducted as a single-blind clinical trial. The patient will be blinded about surgery methods.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic anal fissure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In tailored Sphincterotomy group , a No. 34 purse-string anoscope will be inserted and rotated circumferentially. Any areas of tightness will be incised using electrocautery. The fissure will be assessed, and thickened edges or apical skin tags (if present) will be excised. The surgeon will ensure that the electrocautery does not extend beyond the dentate line. The extent of sphincterotomy will be precisely adjusted based on fissure height. Intervention 2: Control group: . In conventional partial Sphincterotomy, 30% of the exposed internal sphincter will be cut. The incision site will be repaired with absorbable sutures and dressed.</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 No further information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Naser Masoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini hospital., Ershad street., Modarres Blvd., Urmia, Iran.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>57157-81351</zip>
        <telephone>+98 44 3345 7286</telephone>
        <email>masoudi.n@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Naser Msoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini hospital., Ershad street., Modarres Blvd., Urmia, Iran.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>57157-81351</zip>
        <telephone>+98 44 3345 7286</telephone>
        <email>masoudi.n@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18-65 old years
Chronic anal fissure lasting more than one month
Exhibiting signs of chronicity upon anal examination such as the presence of a skin tag
Vsible fibers of the internal anal sphincter at the base of the wound</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with acute fissures
Coexicted fissure  with fistula or inflammatory bowel disease
A history of systemic diseases
A history of anal surgery (for fissure, fistula, or hemorrhoids)
Fecal incontinence
Perineal tears following delivery
Prior radiotherapy
Use of corticosteroids or other immunosuppressive drugs
pregnant women</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 - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In tailored Sphincterotomy group , a No. 34 purse-string anoscope will be inserted and rotated circumferentially. Any areas of tightness will be incised using electrocautery. The fissure will be assessed, and thickened edges or apical skin tags (if present) will be excised. The surgeon will ensure that the electrocautery does not extend beyond the dentate line. The extent of sphincterotomy will be precisely adjusted based on fissure height.</i_keyword>
      <i_keyword>Control group: . In conventional partial Sphincterotomy, 30% of the exposed internal sphincter will be cut. The incision site will be repaired with absorbable sutures and dressed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Complete treatment of Fischer. Timepoint: Weeks one, four, eight, and 6 months after surgery. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Gas incontinence. Timepoint: Weeks one, four, eight, and 6 months after surgery. Method of measurement: Questioning the patient.</prim_outcome>
      <prim_outcome>Fecal incontinence. Timepoint: Weeks one, four, eight, and 6 months after surgery. Method of measurement: Questioning the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain score. Timepoint: After surgery during recovery. Method of measurement: Visual Analogue Scale (VAS).</sec_outcome>
      <sec_outcome>Dosage of analgesia. Timepoint: 24 hours after surgery. Method of measurement: Milligram.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-12</approval_date>
        <contact_name>Ethics Committee of Imam Khomeini Hospital, Urmia University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini hospital, Ershad street, Modarres Blvd., Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
