<?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>IRCT20230602058367N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>results and complications of phenol injection in the treatment of patients with simple pilonidal sinus</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the results and complications of phenol injection in the treatment of patients with simple pilonidal sinus referred to Imam Khomeini Hospital in ۲۰۲۳</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71647</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Pilonidal sinus.</hc_freetext>
      <i_freetext>Among the patients with pilonidal sinus disease referred in 2023, people with a simple form of pilonidal sinus (with only a hole in the midline), without previous history of surgical treatment, will be selected as the inclusion criteria for the study.If there is a lateral extension (secreting hole on the outside of the midline) and an abscess, the patient will be excluded from the study (exclusion criteria).Among the selected people, different treatment methods will be explained. The advantages and disadvantages of using phenol will be explained, and if they are satisfied, the candidate will be treated with phenol crystal and will be included in the study.The required phenol crystal is provided through the Faculty of Pharmacy.After entering the study, on the day of surgery and after admitting the patient to the operating room, the patient lies in the prone position on the bed of the operating room. After exposing the surgical site and disinfecting the site with betadine (prep) and dropping them (drape), xylocaine/lidocaine anesthetic is injected. After obtaining the desired anesthesia, the surrounding area is lubricated with silver sulfadiazine or zinc oxide ointment (to protect the skin), probing is performed through the existing holes. After obtaining the size of the sinus by measuring the tip of the probe, the inside of the sinus is physically deepened by a curette and the material inside the sinus is removed. Then the phenol crystal will enter the sinus (the crystal will melt after contact with the body due to heat). After the effect of phenol, secretions and debris inside the sinuses will be removed. After finishing the work and cleaning the position, sterile dressing will be done..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The result of the study

When:
After publication

To whom:
Students and faculty

Conditions:
Conduct additional research

Where to obtain:
executor of plan

How to obtain:
Email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>MohammadJavad Sheikhaboli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119 2112</telephone>
        <email>mjavadsh14@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Keshvari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119</telephone>
        <email>keshvari@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with a simple form of pilonidal sinus (only having a secretory pit in the mid- line)
No previous history of surgical treatment</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of lateral extention (secretion pit on the outside of the midline).
presence of abscess</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L05.92</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pilonidal sinus without abscess</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Among the patients with pilonidal sinus disease referred in 2023, people with a simple form of pilonidal sinus (with only a hole in the midline), without previous history of surgical treatment, will be selected as the inclusion criteria for the study.If there is a lateral extension (secreting hole on the outside of the midline) and an abscess, the patient will be excluded from the study (exclusion criteria).Among the selected people, different treatment methods will be explained. The advantages and disadvantages of using phenol will be explained, and if they are satisfied, the candidate will be treated with phenol crystal and will be included in the study.The required phenol crystal is provided through the Faculty of Pharmacy.After entering the study, on the day of surgery and after admitting the patient to the operating room, the patient lies in the prone position on the bed of the operating room. After exposing the surgical site and disinfecting the site with betadine (prep) and dropping them (drape), xylocaine/lidocaine anesthetic is injected. After obtaining the desired anesthesia, the surrounding area is lubricated with silver sulfadiazine or zinc oxide ointment (to protect the skin), probing is performed through the existing holes. After obtaining the size of the sinus by measuring the tip of the probe, the inside of the sinus is physically deepened by a curette and the material inside the sinus is removed. Then the phenol crystal will enter the sinus (the crystal will melt after contact with the body due to heat). After the effect of phenol, secretions and debris inside the sinuses will be removed. After finishing the work and cleaning the position, sterile dressing will be done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain,. Timepoint: Periods of 1, 2, 3, 6, 9 and 12 months. Method of measurement: Call or visit the clinic in person.</prim_outcome>
      <prim_outcome>Need to take painkillers. Timepoint: Periods of 1, 2, 3, 6, 9 and 12 months. Method of measurement: Call or visit the clinic in person.</prim_outcome>
      <prim_outcome>Discharge or infection. Timepoint: Periods of 1, 2, 3, 6, 9 and 12 months. Method of measurement: Call or visit the clinic in person.</prim_outcome>
      <prim_outcome>Rest period and time to return to normal activity. Timepoint: Periods of 1, 2, 3, 6, 9 and 12 months. Method of measurement: Call or visit the clinic in person.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Need to take painkillers. Timepoint: Periods of 1, 2, 3, 6, 9 and 12 months. Method of measurement: Call or visit the clinic in person.</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>Research and Technology Vice-Chancellor</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-18</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Dr. Gharib Street- At the end of Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
