<?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>IRCT20230828059288N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-30</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of high dose vitamin C on preventing  anastomotic leakage after colon anastomosis surgery</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of high dose ascorbic acid on preventing  anastomotic leakage after colon anastomosis surgery: a randomized clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72307</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The method of random allocation in this study is Balanced Block Randomization. 6 blocks AABB- ABAB_ ABBA- BBAA- BABA_ BAAB are numbered based on 1 to 6 and numbers 1 to 6 are selected from the table of random numbers and placed together. Then they are replaced with numbered blocks, Blinding description: The surgical resident receives the drugs which are coded in closed envelopes and injects them into the patients. Coding is done by one of the colleagues of the project and the doctor, surgical resident, and patient are blinded.</study_design>
      <phase>2</phase>
      <hc_freetext>Anastomotic leakage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Injection of 10 mg of ascorbic acid with a concentration of 1000 as a single dose and daily starting 12 hours after colorectal anastomosis surgery for five days; product in the form of two ampoules of vitamin C with a concentration of 500 mg and a volume of 5 ml It is prepared from Osweh Pharmaceutical Company. Intervention 2: Control group: Injection of 10 mg of distilled water.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farid Zare Ganjaroodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3471976161</zip>
        <telephone>+98 28 3379 0620</telephone>
        <email>Faridz1991@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farid Zare Ganjaroodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>22 Bahman Blvd, Tavon Square, Elahiye Quay, Minodar Town</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3471976161</zip>
        <telephone>+98 28 3379 0620</telephone>
        <email>Faridz1991@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Colon anastomosis surgery candidate
Age range 18-80</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having diabetes
Heart ischemic disease
Malnutrition (low nutritional standards, including albumin &lt; 3.4 g/dl)
Obese patients
Steroidal and non-steroidal anti-inflammatories consumption
Pregnancy
Patients undergoing chemotherapy
History of previous abdominal surgery
Immune system diseases
Vitamin C allergy
Taking any type of vitamin supplement at least 3 years ago</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K91.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other intraoperative and postprocedural complications and disorders of digestive system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Injection of 10 mg of ascorbic acid with a concentration of 1000 as a single dose and daily starting 12 hours after colorectal anastomosis surgery for five days; product in the form of two ampoules of vitamin C with a concentration of 500 mg and a volume of 5 ml It is prepared from Osweh Pharmaceutical Company</i_keyword>
      <i_keyword>Control group: Injection of 10 mg of distilled water</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Active secretions from the drain site. Timepoint: From the time of the end of the surgery to ten days after that. Method of measurement: Clinical examination by a doctor.</prim_outcome>
      <prim_outcome>Leukocytosis (More than 11,000 white blood cells in one microliter of blood. Timepoint: From the time of the end of the surgery to ten days after that. Method of measurement: CBC test.</prim_outcome>
      <prim_outcome>Fistula (an abnormal passageway between adjacent organs or tissues or leading to the outside of the body). Timepoint: From the time of the end of the surgery to ten days after that. Method of measurement: Clinical examination by a doctor.</prim_outcome>
      <prim_outcome>Malaise (disordered, weak and lethargic appearance, reduced alertness and lack of mastery and awareness of the surrounding environment and restlessness). Timepoint: From the time of the end of the surgery to ten days after that. Method of measurement: Clinical examination by a doctor.</prim_outcome>
      <prim_outcome>Fever (body temperature 38 degrees Celsius or higher). Timepoint: From the time of the end of the surgery to ten days after that. Method of measurement: thermometer.</prim_outcome>
      <prim_outcome>Recovery time (the number of days the patient is eligible to be discharged from the hospital). Timepoint: From the time of the end of the surgery to ten days after that. Method of measurement: Clinical examination by a doctor.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-12</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Research and Technology deputy, 1st Branch, Maudet Alley, Shahid Beheshti Blvd, Qazvin Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
