<?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>IRCT20180514039651N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-13</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Appendicostomy in rectal cancer</public_title>
      <acronym></acronym>
      <scientific_title>Effect of appendicostomy on functional outcomes and quality of life in patients undergoing surgery abdominoperineal resection due to rectal cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31203</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Rectal cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Appendicostomy: Surgery is done in two steps. First, after the release of the disending colon, the inferior mesenteric artery and vein are high ligated. The sigmoid colon is removed from the middle portion. Then the perineal phase is done and The complex of anal sphincter and the rectum and distal sigmoid are resected and left side colostomy are inserted and perineal incision are closed. At the same time, an appendicectomy is inserted for patient.To do this, the appendix is ​​dissected and the longitudinal insision of the distal appendices is done,then in right lower quadrant skin U shape insision is performed and anti mesenteric edges are sutured to the skin with 4-0 absorbable. A small catheter is placed in the appendicectomy for a week and the first antegrade enema with one liter of water is done. The necessary care and method of using appendicectomy is given to patients before discharge. Intervention 2: Control group: without appendicostomy: First, after the release of the disending colon, the inferior mesenteric artery and vein are high ligated. The sigmoid colon is removed from the middle portion. Then the perineal phase is done and The complex of anal sphincter and the rectum and distal sigmoid are resected and left side colostomy are inserted and perineal incision are closed.</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:
The questionnaie of patients

When:
At the same as the results

To whom:
University researchers

Conditions:
...

Where to obtain:
Sari Imam Khomeini Hospital

How to obtain:
...

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amin Salimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahband Ave., Tohid all.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815696869</zip>
        <telephone>+98 935 856 6806</telephone>
        <email>dr.aminsalimi@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amin Salimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahband Ave., Tohid all.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815696869</zip>
        <telephone>+98 935 856 6806</telephone>
        <email>dr.aminsalimi@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Rectal adenocarcinoma confirmed by pathology
Patients with operable low or very low Rectal cancer or patients with operable high stage Rectal cancer after neoadjuvant therapy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Heart failure
Mental retardation
Diabetes
High dose Corticosteroid therapy
Immunodeficiency
Cases that have delay in wound healing</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C21.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of overlapping sites of rectum, anus and anal canal</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Appendicostomy: Surgery is done in two steps. First, after the release of the disending colon, the inferior mesenteric artery and vein are high ligated. The sigmoid colon is removed from the middle portion. Then the perineal phase is done and The complex of anal sphincter and the rectum and distal sigmoid are resected and left side colostomy are inserted and perineal incision are closed. At the same time, an appendicectomy is inserted for patient.To do this, the appendix is ​​dissected and the longitudinal insision of the distal appendices is done,then in right lower quadrant skin U shape insision is performed and anti mesenteric edges are sutured to the skin with 4-0 absorbable. A small catheter is placed in the appendicectomy for a week and the first antegrade enema with one liter of water is done. The necessary care and method of using appendicectomy is given to patients before discharge.</i_keyword>
      <i_keyword>Control group: without appendicostomy: First, after the release of the disending colon, the inferior mesenteric artery and vein are high ligated. The sigmoid colon is removed from the middle portion. Then the perineal phase is done and The complex of anal sphincter and the rectum and distal sigmoid are resected and left side colostomy are inserted and perineal incision are closed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score of EORTC-QLQ-C30 (The European organization for research and treatment of cancer quality of life questionnaire). Timepoint: 3, 6, 12 months after surgery. Method of measurement: EORTC-QLQ-C30(The European organization for research and treatment of cancer quality of life questionnaire).</prim_outcome>
      <prim_outcome>Evaluation of continence in Wexner questinnaire. Timepoint: 3, 6, 12 months after surgery. Method of measurement: Wexner questionnaire.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-22</approval_date>
        <contact_name>Ethics committee of Sari University of Medical Sciences</contact_name>
        <contact_address>Tohid Alley, Shahband Ave., Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
