<?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>IRCT20200629047952N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-04</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>Effect of preoperative oral carbohydrt loading</public_title>
      <acronym></acronym>
      <scientific_title>effect of preoperative oral carbohydrate loading on laparoscopic outcome and metabolic respons</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49456</url>
      <study_type>observational</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Use a random number table for verification. Direction Use Random Number Table Start reading the set table numbers The numbers will then be considered for different groups Be. Lay on one of the numbers and in one direction in advance Moves are assigned and assigned numbers to different feature groups I was doing, Blinding description: The study will be blinded in two ways. Patients according to type The intervention is blinded as well as the researcher who must enter the data into the checklist Relevant will be blinded to the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Npo time.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group is loaded with glucose as follows, first 12.5% ​​solution at a rate of 800 cc in the evening before surgery and then a solution at a rate of 400 cc 2 to 4 hours before surgery.Then albumin, crp, the ratio of the two to each other, as well as the amount of pain and the use of analgesics in 6 hours after surgery, and the same hours the next day and two days after surgery will be measured. Finally, the collected data will be analyzed and compared. Intervention 2: Control group :Control group: 400 cc of water is given to the patient 2 clocks before the operation, if desired. Water was given with aspartame sugar, which is a sweet solution and has zero calories. After that, the operation of the variables is checked and completed.</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:
Clinical information on the effects of loading. Carbohydrates on reducing postoperative complications will be fully shared and laboratory and demographic data will be shared

When:
۲۰۲۱

To whom:
Universities and scientific authorities of the iran

Conditions:
Scientific

Where to obtain:
Alborz University of Medical Sciences Research Assistant Karaj. Taleghani Square Research Deputy Postal Code 3183966987 Phone 02634287335

How to obtain:
Competent and enthusiastic researchers can document data after publication Work of the responsible author by providing academic information and self-identification .To receive

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi tavalaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azimiyeh, emam ali hospital</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۱۱۱۱۱۱۱</zip>
        <telephone>+98 26 3670 5593</telephone>
        <email>Ehsanbeigi87@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi tavalaer</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azimiye, emam ali hospital</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۱۱۱۱۱۱</zip>
        <telephone>+98 26 3670 5593</telephone>
        <email>Ehsanbeigi87@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age upper18 ,under 70 years
Elective surgery cholelitiasis laparoscopy
Persian language</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Emergen and urgent surgery
Acute and chronic cholecystit
Bmi less of 20 and more than 30
Metabolic syndrom</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group is loaded with glucose as follows, first 12.5% ​​solution at a rate of 800 cc in the evening before surgery and then a solution at a rate of 400 cc 2 to 4 hours before surgery.Then albumin, crp, the ratio of the two to each other, as well as the amount of pain and the use of analgesics in 6 hours after surgery, and the same hours the next day and two days after surgery will be measured. Finally, the collected data will be analyzed and compared</i_keyword>
      <i_keyword>Control group :Control group: 400 cc of water is given to the patient 2 clocks before the operation, if desired. Water was given with aspartame sugar, which is a sweet solution and has zero calories. After that, the operation of the variables is checked and completed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: ۰،۶،۱۲،۲۴،(houres), 3,7 dayes. Method of measurement: Vas, cc,need to analtgic.</prim_outcome>
      <prim_outcome>Leakage of drain. Timepoint: O,6,12,24,48 hours. Method of measurement: Mililiter.</prim_outcome>
      <prim_outcome>Vomiting. Timepoint: 6,12,24 ,48 hours. Method of measurement: Need to ondansetron.</prim_outcome>
      <prim_outcome>Crp. Timepoint: Day 1 and day 2 at 8 am. Method of measurement: Mg.</prim_outcome>
      <prim_outcome>Albumin. Timepoint: Day 1 day 2 at 8 am. Method of measurement: Mg.</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>2021-05-02</approval_date>
        <contact_name>Ethcs committee of alborz university of medical sciences</contact_name>
        <contact_address>Taleghani sq.  Alborz uineversity Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
