<?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>IRCT20171120037552N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of mechanical intestinal preparation with Polyethylene glycol</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of mechanical intestinal preparation with 6 and 4 packaged Polyethylene glycol  with telephon based re-education before colonoscopy on adequacy of intestinal preparation, safety and acceptance of patients  undergoing  colonoscopy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27742</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Randomization tool using statistical software, Blinding description: 1-Patients in the study are not known About the type of preparation regimen.
2-Routine Complications Preparation is measured through a Special research tool By researcher help that does not know  of the preparation regimen.
3-The endoscopic specialist does not know the type of bowel preparation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients under colonoscopy.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Four polyethylene glycol packages.                           Interventions include:  On the first day, patients will eat soft diet and much fluid at least 24 to 30 glasses .                                                                    The second day, patients will eat' Smooth fluid and much fluid at least 24 to 30 glasses a day.                                                                                        Patients on the day of referral receive 4 packets of polyethylene glycol, 6 bisacodyl tablet and one bisacodyl suppository per day for colonoscopy. Patients take 2 packs of this powder plus 4 tablet of bisacodyl on the day before colonoscopy, and 2 packs of polyethylene glycol, 2 tablet of biacodyl and one bisacodyl suppository are taken on the morning of the colonoscopy. Also on the referral and colonoscopy day Blood tests are taken from patients.                                                                                  These tests include Mg, P, Na, k, Ca, BUN.cr. Intervention 2: Intervention group 1: Six packet of polyethylene glycol.            Interventions include:  On the first day, patients will eat soft diet and much fluid at least 24 to 30 glasses .                                                                    The second day, patients will eat' Smooth fluid and much fluid at least 24 to 30 glasses a day.                                                                                                     Patients on the day of referral receive 6 packets of polyethylene glycol, 10 bisacodyl tablet and one bisacodyl suppository per day for colonoscopy. Patients take 4 packs of this powder plus 8 tablet of bisacodyl on the day before colonoscopy, and 2 packs of polyethylene glycol, 2 tablet of biacodyl and one bisacodyl suppository are taken on the morning of the colonoscopy.                                                                                                              Also on the referral and colonoscopy day Blood tests are taken from patients.                                                                                                               These tests include Mg, P, Na, k, Ca, BUN.cr. Intervention 3: Intervention group 2: Four polyethylene glycol packets by telephone base re-education.                                                                                  Interventions include:  On the first day, patients will eat soft diet and much fluid at least 24 to 30 glasses .                                                                    The second day, patients will eat' Smooth fluid and much fluid at least 24 to 30 glasses a day.                                                                                        Patients on the day of referral receive 4 packets of polyethylene glycol, 6 bisacodyl tablet and one bisacodyl suppository per day for colonoscopy. Patients take 2 packs of this powder plus 4 tablet of bisacodyl on the day before colonoscopy, and 2 packs of polyethylene glycol, 2 tablet of biacodyl and one bisacodyl suppository are taken on the morning of the colonoscopy.In addition, the nurse on the day before the colonoscopy (second day), followed by a 5 to 10 minute phone call follow up by the patients in the third group and responded if there was a question.                         Also on the referral and colonoscopy day Blood tests are taken from patients.                                                                                                                        These tests include Mg, P, Na, k, Ca, BUN.cr.</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 The file contains patient information in the colonoscopy section.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Reza Mazlom</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Mazlomr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Reza Mazlom</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>mazlomr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To be satisfied to participate in the study .
Aged 18 to 64 years old.
At the present time, Not to be treated for liver and kidney disease.
There are no symptoms of intestinal obstruction (prolonged constipation, abdominal distension and sometimes sensitivity to touch, abdominal pain, nausea and vomiting, certain radiographic findings).
Has not History of surgery to remove all or part of the colon.
Not be Pregnant.
Not have hearing problem.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>64 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The Intestinal preparation protocol Completely dose not implementate.
Do not want to continue to cooperation.</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Four polyethylene glycol packages.                           Interventions include:  On the first day, patients will eat soft diet and much fluid at least 24 to 30 glasses .                                                                    The second day, patients will eat' Smooth fluid and much fluid at least 24 to 30 glasses a day.                                                                                        Patients on the day of referral receive 4 packets of polyethylene glycol, 6 bisacodyl tablet and one bisacodyl suppository per day for colonoscopy. Patients take 2 packs of this powder plus 4 tablet of bisacodyl on the day before colonoscopy, and 2 packs of polyethylene glycol, 2 tablet of biacodyl and one bisacodyl suppository are taken on the morning of the colonoscopy. Also on the referral and colonoscopy day Blood tests are taken from patients.                                                                                  These tests include Mg, P, Na, k, Ca, BUN.cr.</i_keyword>
      <i_keyword>Intervention group 1: Six packet of polyethylene glycol.            Interventions include:  On the first day, patients will eat soft diet and much fluid at least 24 to 30 glasses .                                                                    The second day, patients will eat' Smooth fluid and much fluid at least 24 to 30 glasses a day.                                                                                                     Patients on the day of referral receive 6 packets of polyethylene glycol, 10 bisacodyl tablet and one bisacodyl suppository per day for colonoscopy. Patients take 4 packs of this powder plus 8 tablet of bisacodyl on the day before colonoscopy, and 2 packs of polyethylene glycol, 2 tablet of biacodyl and one bisacodyl suppository are taken on the morning of the colonoscopy.                                                                                                              Also on the referral and colonoscopy day Blood tests are taken from patients.                                                                                                               These tests include Mg, P, Na, k, Ca, BUN.cr.</i_keyword>
      <i_keyword>Intervention group 2: Four polyethylene glycol packets by telephone base re-education.                                                                                  Interventions include:  On the first day, patients will eat soft diet and much fluid at least 24 to 30 glasses .                                                                    The second day, patients will eat' Smooth fluid and much fluid at least 24 to 30 glasses a day.                                                                                        Patients on the day of referral receive 4 packets of polyethylene glycol, 6 bisacodyl tablet and one bisacodyl suppository per day for colonoscopy. Patients take 2 packs of this powder plus 4 tablet of bisacodyl on the day before colonoscopy, and 2 packs of polyethylene glycol, 2 tablet of biacodyl and one bisacodyl suppository are taken on the morning of the colonoscopy.In addition, the nurse on the day before the colonoscopy (second day), followed by a 5 to 10 minute phone call follow up by the patients in the third group and responded if there was a question.                         Also on the referral and colonoscopy day Blood tests are taken from patients.                                                                                                                        These tests include Mg, P, Na, k, Ca, BUN.cr.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adequacy of intestinal preparation, safety and patient acceptance under colonoscopy. Timepoint: Day of recurrences for colonoscopy and the day of colonoscopy. Method of measurement: The adequacy of intestinal preparation through the Boston instrument and the patient's acceptance through a checklist questionnaire and the safety of the patient are measured by checking blood electrolytes.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-17</approval_date>
        <contact_name>Ethics committee Mashhad University of medical sciences</contact_name>
        <contact_address>Gaem hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
