<?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>IRCT20200118046174N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-13</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Enhanced Recovery After Surgery (ERAS) protocol on isolated tibial fracture surgery’s outcome</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Enhanced Recovery After Surgery (ERAS) protocol on isolated tibial fracture surgery’s outcome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60082</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Simple randomization is performed using a table of random numbers. In this method, the table of numbers is created without any specific pattern and order, then the numbers in the first column from top to bottom are assigned to the referring patients, respectively. If the number assigned to a patient is odd, that patient enters the intervention group (group A) and if it is even, he/she enters the control group (group B). At the end, each group is given explanations and instructions related to them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tibial fracture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They will be instructed to stop eating and drinking all foods except clear fluids(water, light tea and coffee) 6 hours before surgery and stop drinking clear fluids 2 hours before surgery. Intervention 2: Control group: They will be instructed no to eat or drink any food after 00:00 a.m. the night before surgery.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Ashouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeyni st. , S Kargar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>١١٣٦٧٤٦٩١١</zip>
        <telephone>098 21 63121417</telephone>
        <email>mohammad.ashouri1@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ashouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeyni st. , S Kargar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>١١٣٦٧٤٦٩١١</zip>
        <telephone>+98 21 6312 1417</telephone>
        <email>mohammad.ashouri1@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients visiting Sina and Shariati hospitals' emergency room for an isolated tibial fracture during the year 1400 who will undergo surgery in the same center</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age below 18 years old
Age above 65 years old
Not using tourniquet during the operation
Pregnancy
Multiple trauma
The surgery is performed after 72 hours since hospitalisation
Any other concurrent fracture except for Fibular fracture
ASA score above 3</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M84.36</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress fracture, tibia and fibula</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: They will be instructed to stop eating and drinking all foods except clear fluids(water, light tea and coffee) 6 hours before surgery and stop drinking clear fluids 2 hours before surgery.</i_keyword>
      <i_keyword>Control group: They will be instructed no to eat or drink any food after 00:00 a.m. the night before surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lenght of stay. Timepoint: after release from hospital. Method of measurement: days between date of surgery and date of release from hospital.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postoperative nausea and vomiting. Timepoint: One day after surgery. Method of measurement: Directly asking the patient.</sec_outcome>
      <sec_outcome>Postoperative pain score. Timepoint: One day after surgery. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Blood hemoglobin level changes. Timepoint: One day after surgery. Method of measurement: Laboratory evaluation of hemoglobin level before and after surgery.</sec_outcome>
      <sec_outcome>Blood creatinine changes. Timepoint: One day after surgery. Method of measurement: Laboratory evaluation of blood creatinine level before and after surgery.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-17</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences' Sina hospital</contact_name>
        <contact_address>Tehran Sina Hospital, Men's Orthopedic Department Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
