<?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>IRCT20220530055027N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-15</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>The comparison of single incision laparoscopic appendectomy and conventional laparoscopic appendectomy</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of short time outcomes between single incision laparoscopic appendectomy and conventional laparoscopic appendectomy surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66263</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining informed written consent from the individual and his legal guardian, the allocation of people to treatment groups will be done based on the sequence obtained from the 4 blocks obtained from the address below.
https://www.sealedenvelope.com/simple-randomiser/v1/lists
Also, the list of random allocation in 7 blocks of 4, which makes 28 people in each group, is as follows:
• 1, 4, 1, Group B
• 1, 4, 2, Group B
• 1, 4, 3, Group A
• 1, 4, 4, Group A
• 2, 4, 1, Group B
• 2, 4, 2, Group A
• 2, 4, 3, Group A
• 2, 4, 4, Group B
• 3, 4, 1, Group B
• 3, 4, 2, Group A
• 3, 4, 3, Group B
• 3, 4, 4, Group A
• 4, 4, 1, Group A
• 4, 4, 2, Group B
• 4, 4, 3, Group A
• 4, 4, 4, Group B
• 5, 4, 1, Group A
• 5, 4, 2, Group B
• 5, 4, 3, Group A
• 5, 4, 4, Group B
• 6, 4, 1, Group B
• 6, 4, 2, Group A
• 6, 4, 3, Group A
• 6, 4, 4, Group B
• 7, 4, 1, Group A
• 7, 4, 2, Group A
• 7, 4, 3, Group B
• 7, 4, 4, Group B, Blinding description: In this one-sided blind study, the patients will be unconscious during the surgery and will not be informed about which method the surgery will be performed. The research team (interviewers) will know which surgery was performed on which person.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Single incision laparoscopic appendectomy (SILA). Condition 2: Conventional laparoscopic appendectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Single-incision laparoscopic appendectomy. Intervention 2: Control group: Conventional laparoscopic appendectomy.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Khaleghi Rostamkolaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 2, 1st sarv, sarv st, east farsad Blv, Taavon Blv. Shahre Ziba</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1487765415</zip>
        <telephone>+98 21 4410 8369</telephone>
        <email>atousakhaleghi71@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Khaleghi rostamkolaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 2, 1st sarv, sarv st, east farsad Blv, Taavon Blv. Shahre Ziba</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1487765415</zip>
        <telephone>+98 21 4410 8369</telephone>
        <email>atousakhaleghi71@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent to participate in the research
Age under 20 years
Stable patient</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>20 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Over 20 years old
Abdominal infection
Emergency Case
Pregnancy
Perforated appendicitis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K35</hc_code>
      <hc_code>K35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute appendicitis</hc_keyword>
      <hc_keyword>Acute appendicitis</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: Single-incision laparoscopic appendectomy</i_keyword>
      <i_keyword>Control group: Conventional laparoscopic appendectomy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The degree of beauty of the operation site. Timepoint: Up to 3 weeks after surgery. Method of measurement: Based on the PSQ questionnaire.</prim_outcome>
      <prim_outcome>The amount of pain after the operation. Timepoint: Up to 3 weeks after surgery. Method of measurement: Based on the VAS questionnaire.</prim_outcome>
      <prim_outcome>Types of complications after surgery. Timepoint: Up to 3 weeks after surgery. Method of measurement: Self-Report.</prim_outcome>
      <prim_outcome>Duration of operation. Timepoint: During surgery. Method of measurement: Based on the duration of surgery.</prim_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: From after surgery to discharge. Method of measurement: Record the number of days of hospitalization.</prim_outcome>
      <prim_outcome>Duration of leukocytosis drop. Timepoint: It is measured once before the operation and once or twice after the operation. Method of measurement: Record the duration of leukocytosis drop.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-24</approval_date>
        <contact_name>Ethics Committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>Ethics committee office, 2nd floor, Research and Technology Vice-Chancellor, Safarian alley, 45 merti Golshahr Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
