<?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>IRCT20210513051286N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-23</date_registration>
      <primary_sponsor>Trakya University Faculty of Health Sciences</primary_sponsor>
      <public_title>EFFECT OF MONITORING FOOD IMAGES AFTER RECTAL SURGERY</public_title>
      <acronym></acronym>
      <scientific_title>MONITORING FOOD IMAGES AFTER RECTAL SURGERY TO ACCELERATE RECOVERY OF POSTOPERATIVE BOWEL MOTILITY: A QUASI-EXPERIMENTAL STUDY</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56277</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Postoperative bowel motility. Condition 2: Postoperative complications. Condition 3: Postoperative motility of digestive system.</hc_freetext>
      <i_freetext>A food pictures booklet was prepared for the patients in the experimental group. This 30-page booklet included different and colorful photographs of foods and fruits.The researchers performed the clinical daily visits to determine the patients who met the sampling criteria and were to undergo planned rectal surgery. And then, information about the aim and application of the study was given to the patients, and patients who volunteered to participate in the study were included in the study.It included patients who volunteered to monitor food pictures in the experimental group, and it included the patients who reported that they did not want to monitor food pictures in the control group.50 patients, including 25 patients in each group, were assigned to the study. Two patients who were in the experimental group excluded from the sample because they resisted watching food pictures during the data collection process. Consequently, the study was conducted with 48 patients. Patients in each group received the routine postoperative care applied in the clinic. From the first morning after surgery until defecation, patients in the experimental group were asked to monitor food pictures thrice a day, parallel to their meals. Flatus and defecation times of the patients were followed and written on the data collection form..</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:
Only IPD collected for the primary outcome measure will be shared.

When:
Documents/data files will become available starting 1 year after publication.

To whom:
Deidentified IPD and any additional supporting information/documents will be shared for people working in academic institutions.

Conditions:
Deidentified IPD and any additional supporting information/documents will be shared by corresponding author via e-mail.

Where to obtain:
Sacide YILDIZELI TOPCU
e-mail: sacideyildizeli@trakya.edu.tr

How to obtain:
One year after the publication of the article containing study reports, the responsible author can be contacted via e-mail for receiving the documents /data files

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sacide Yildizeli Topcu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Trakya University Faculty of Health Sciences</address>
        <city>Edirne</city>
        <country1>Turkey</country1>
        <zip>22020</zip>
        <telephone>+90 284 213 30 42</telephone>
        <email>sacideyildizeli@trakya.edu.tr</email>
        <affiliation>Trakya University Faculty of Health Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sacide Yildizeli Topcu</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Trakya University Faculty of Health Sciences</address>
        <city>Edirne</city>
        <country1>Turkey</country1>
        <zip>22020</zip>
        <telephone>+90 284 213 30 42</telephone>
        <email>sacideyildizeli@trakya.edu.tr</email>
        <affiliation>Trakya University Faculty of Health Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Turkey</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who underwent open rectal surgery due to colorectal cancer
Patients who did not receive epidural anesthesia or analgesia in the intraoperative or postoperative period
Patients who had no nasogastric catheter
Patients who were mobilized within 24 hours during the post-operative period
Patients whose surgery was performed by the same surgeon</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have complications developed during or after surgery
Patients who need treatment in the intensive care unit after surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K56.0</hc_code>
      <hc_code>R19.4</hc_code>
      <hc_code>K91.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Paralytic ileus</hc_keyword>
      <hc_keyword>Change in bowel habit</hc_keyword>
      <hc_keyword>Other intraoperative and postprocedural complications and disorders of digestive system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>A food pictures booklet was prepared for the patients in the experimental group. This 30-page booklet included different and colorful photographs of foods and fruits.The researchers performed the clinical daily visits to determine the patients who met the sampling criteria and were to undergo planned rectal surgery. And then, information about the aim and application of the study was given to the patients, and patients who volunteered to participate in the study were included in the study.It included patients who volunteered to monitor food pictures in the experimental group, and it included the patients who reported that they did not want to monitor food pictures in the control group.50 patients, including 25 patients in each group, were assigned to the study. Two patients who were in the experimental group excluded from the sample because they resisted watching food pictures during the data collection process. Consequently, the study was conducted with 48 patients. Patients in each group received the routine postoperative care applied in the clinic. From the first morning after surgery until defecation, patients in the experimental group were asked to monitor food pictures thrice a day, parallel to their meals. Flatus and defecation times of the patients were followed and written on the data collection form.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative first flatus time. Timepoint: Postoperative 1. day and following days. Method of measurement: Postoperative first flatus time were followed as day.</prim_outcome>
      <prim_outcome>Postoperative first defecation time. Timepoint: Postoperative 1. day and following days. Method of measurement: Postoperative first  defecation time were followed as day.</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>Trakya University Faculty of Health Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-07</approval_date>
        <contact_name>Trakya University Faculty of Medicine Scientific Research Ethics Committee</contact_name>
        <contact_address>Trakya University Balkan Campus Edirne Merkez Turkey</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
