<?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>IRCT201206072982N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-09-04</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Single-incision laparoscopic cholecystectomy and mini-laparoscopic cholecystectomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Single-incision laparoscopic cholecystectomy and mini-laparoscopic cholecystectomy in Shariati hospital between 2012 to 2014: A Randomized Clinical Trial Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2904</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>Calculus of gallbladder without cholecystitis.</hc_freetext>
      <i_freetext>Intervention 1: In the MLC group, a 10- millimeter port was placed in the lower area of the navel, a 2.7- millimeter port was placed in the epigastric region, a 2.7-millimeter port was placed 2 centimeters below the ribs, and another 2.7- millimeter port was placed in the lower right side of the anterior axillary line. A 10- millimeter camera was sent in from the first port and the grasper holding the fundus of the gallbladder was sent in through the last port. The gallbladder was then taken out from the 10- millimeter port. After the laparoscopic cholecystectomy, the patients underwent the recovery period of the operating room and were transferred to the ward. Paracetamol was used as the base pain reliever and was given to the patients for 48 hours, 1 gram every 8 hours. In case of severe pain, 25 grams of Pethidine was slowly injected into the vein. Intervention 2: In the SLIC Group: the main port was placed in the lower area of the navel, and the graspers and camera was entered through same port and cholecystectomy was performed. Then, the gallbladder was taken out from the navel location. The fascia and skin will be closed at the site of navel.</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>Dr. Zhamak Khorgami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>General Surgery Ward, Shariati Hospital, North Kargar St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2450</telephone>
        <email>khorgami@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences - Shariati Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zhamak Khorgami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>General Surgery Ward, Shariati Hospital, North Kargar St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2450</telephone>
        <email>khorgami@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences - Shariati hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: patients being admitted in Tehran Shariati Hospital with symptomatic cholelithiasis who are candidates of laparoscopic cholecystectomy.&#13;
Exclusion criteria: ages more than 60; having Common Bile Duct stone, obesity (BMI equal or more than 40), acute cholelithiasis, and previous surgeries in the upper abdominal areas.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K80.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Any condition listed in K80.5 with cholangitis</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>In the MLC group, a 10- millimeter port was placed in the lower area of the navel, a 2.7- millimeter port was placed in the epigastric region, a 2.7-millimeter port was placed 2 centimeters below the ribs, and another 2.7- millimeter port was placed in the lower right side of the anterior axillary line. A 10- millimeter camera was sent in from the first port and the grasper holding the fundus of the gallbladder was sent in through the last port. The gallbladder was then taken out from the 10- millimeter port. After the laparoscopic cholecystectomy, the patients underwent the recovery period of the operating room and were transferred to the ward. Paracetamol was used as the base pain reliever and was given to the patients for 48 hours, 1 gram every 8 hours. In case of severe pain, 25 grams of Pethidine was slowly injected into the vein.</i_keyword>
      <i_keyword>In the SLIC Group: the main port was placed in the lower area of the navel, and the graspers and camera was entered through same port and cholecystectomy was performed. Then, the gallbladder was taken out from the navel location. The fascia and skin will be closed at the site of navel.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of durgery. Timepoint: from the time the skin was cut until the time it was closed. Method of measurement: recorded by surgeon.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain after surgery. Timepoint: 8, 16, and 24 hours after surgery. Method of measurement: measuring levels of pain using visual analog scale(VAS).</sec_outcome>
      <sec_outcome>Nausea and vomiting after surgery. Timepoint: in the first 24 hours after surgery. Method of measurement: subjective, recorded by observer from the questionnaire.</sec_outcome>
      <sec_outcome>Intraoperative complications. Timepoint: at the end of operation. Method of measurement: recorded by surgeon.</sec_outcome>
      <sec_outcome>Medical complications after surgery: hypertension, ischemia or cardiac arrhythmia. Timepoint: at the time of discharge. Method of measurement: based on medical chart.</sec_outcome>
      <sec_outcome>Hernia at the site  of incisions. Timepoint: 12 months after after surgery. Method of measurement: clinical exam and imagings.</sec_outcome>
      <sec_outcome>Wound infection. Timepoint: up to 1 month after surgery. Method of measurement: office visits and medical charts.</sec_outcome>
      <sec_outcome>Postoperative narcotic usage for pain control. Timepoint: up to 48 hours after surgery. Method of measurement: recorded by nurse in the questionnaire.</sec_outcome>
      <sec_outcome>Total Length of wounds. Timepoint: at the end of operation. Method of measurement: ruler with one millimeter percision.</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 of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethics committee Tehran University of Medical Sciences</contact_name>
        <contact_address>Surgery department, Imam khomeini hospital, Keshavarz boulvard Teharn  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
