<?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>IRCT20200929048879N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-06</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two methods of patient-controlled analgesia through intravenous and thoracic epidural in surgery of esophageal cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two methods of patient-controlled analgesia through intravenous and thoracic epidural to control pain and complications after surgery in esophageal cancer patients at the Cancer Institute of Imam Khomeini Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52691</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Candidate patients for esophageal cancer surgery were divided into two groups by random blocking and using a random number table. The even number of files will be in block A and the odd number in block B. To read counting numbers from top to bottom. Out of 80 randomly selected patients, 40 patients will be implanted in block A before the onset of epidural catheter anesthesia from the thoracic space and an epidural analgesic pump with local anesthetic will be implanted for patients around the end of the operation and 40 patients in block B After anesthesia and surgery near the end of the operation, a venous pump was connected to the peripheral vein for the patients and the patients will undergo intravenous infusion of narcotics and ketorolac. At the end, the two groups will be compared in terms of pain control and short-term complications.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Control of pain and complications after surgery in esophageal cancer patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Patients who have had a thoracic catheter implanted before the epidural anesthesia and an epidural analgesic pump with a local anesthetic will be inserted around the end of the operation. Intervention 2: Intervention group: Patients who after anesthesia and surgery near the end of the venous pump from the peripheral vein is connected to the patient and the patient will undergo intravenous infusion of narcotics and ketorolac.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sina Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 9, No 15, Dead End Salehi, North Jamalzadeh  Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۹۶۴۷۳۱۱</zip>
        <telephone>+98 21 6693 6328</telephone>
        <email>abbassisina@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sina Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 9, No 15, Dead End Salehi, North Jamalzadeh  Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۹۶۴۷۳۱۱</zip>
        <telephone>+98 21 6693 6328</telephone>
        <email>abbassisina@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have referred for esophageal cancer surgery.
Patients in the age range of 20 to 80 years who were candidates for esophageal cancer surgery.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with coagulation disorders.
Infection of the epidural catheter insertion site
Patients with severe hemodynamic disorders.
Patients with severe movement disorders.
Patients with chest disorders.
Patients with neurological disorders.
Patients who are addicted to drugs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>MG30.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic cancer pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Patients who have had a thoracic catheter implanted before the epidural anesthesia and an epidural analgesic pump with a local anesthetic will be inserted around the end of the operation.</i_keyword>
      <i_keyword>Intervention group: Patients who after anesthesia and surgery near the end of the venous pump from the peripheral vein is connected to the patient and the patient will undergo intravenous infusion of narcotics and ketorolac</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Control of pain and complications after surgery in patients undergoing esophageal cancer surgery according to the Global Pain Assessment Tool (UPAT). Timepoint: Before and during esophageal cancer surgery and during hospitalization in the ICU. Method of measurement: Using the Global Pain Assessment Tool (UPAT).</prim_outcome>
      <prim_outcome>Pain score on the second day after esophageal cancer surgery with Global Pain Assessment Tool (UPAT). Timepoint: During hospitalization in the ICU. Method of measurement: Using the Global Pain Assessment Tool (UPAT).</prim_outcome>
      <prim_outcome>Pain score on the third day after esophageal cancer surgery with Global Pain Assessment Tool (UPAT). Timepoint: During hospitalization in the ICU. Method of measurement: Using the Global Pain Assessment Tool (UPAT).</prim_outcome>
      <prim_outcome>Determining the length of hospital stay of patients in the ICU. Timepoint: During hospitalization in the ICU until transfer to the surgical ward. Method of measurement: Clinical symptoms of patients.</prim_outcome>
      <prim_outcome>Extra drug use required based on patients' pain score. Timepoint: After esophageal cancer surgery and during hospitalization in the ICU. Method of measurement: Using the Global Pain Assessment Tool (UPAT).</prim_outcome>
      <prim_outcome>Quarterly survival rate. Timepoint: After surgery up to three months after discharge from the hospital. Method of measurement: Examination of the patient and questions and answers from the patient.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: During surgery until the patient is discharged from the hospital. Method of measurement: Mercury sphygmomanometer.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: During surgery until the patient is discharged from the hospital. Method of measurement: Mercury sphygmomanometer.</prim_outcome>
      <prim_outcome>Count the pulse. Timepoint: During surgery until the patient is discharged from the hospital. Method of measurement: Through standard patient heart rate monitoring.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-21</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Headquarters of Tehran University of Medical Sciences, corner of Ghods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
