<?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>IRCT20141218020364N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-22</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Appendicostomy in reducing the psychological complications of rectal cancer patients undergoing inter-sphincter very low anterior resection</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of functional and quality of life outcomes in patients with very low rectal cancer undergoing an inter sphincter resection with and without appendicostomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33318</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization using the table of random numbers.</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 descending colon, the inferior mesenteric artery and vein are high lighted. The sigmoid colon is removed from the middle portion. Then the perineal phase is done and throws intersphincter groove complex of ithe nternal anal sphincter and the rectum and distal sigmoid are resect then end to end coloanal anastomosis using PDS 3.0 will be done. At the same time, an appendicostomy is inserted for the patient.T o do this, the appendix is dissected and the longitudinal incision of the distal appendices is done, then, in right lower quadrant skin U shape incision is performed and anti mesenteric edges are sutured to the skin with 4-0 absorbable. A small catheter is placed in the appendicostomy for a week and the first antegrade enema with one litre of water is done. The necessary care and method of using appendicostomy is given to patients before discharge. Intervention 2: Control group: without appnndicostomy: first, after the release of the descending colon, the inferior mesenteric artery and vein are high lighted. The sigmoid colon is removed from the middle portion. Then the perineal phase is done and throws intersphincter groove complex of the internal anal sphincter and the rectum and distal sigmoid are resect then end to end coloanal anastomosis using PDS 3.0 will be done.</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 questionnaire 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>Mohammad yasin Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>zand ave</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7441756965</zip>
        <telephone>+98 917 180 0710</telephone>
        <email>karamiy@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad yasin Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand ave</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7441756965</zip>
        <telephone>+98 917 180 0710</telephone>
        <email>karamiy@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Stage 1( T1 ,T2 till mascularis properia) of very low rectal cancer which approved by an endosonography survey and pathologist faculty member based on World Health Organization criteria, those who had neoadjuant chemotherapy.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Chronic Pulmonary disease
Heart failure
diabetes
Mental Retardation
High dose Corticosteroid therapy
Immune deficiency
Poor Follow up condition
other diseases that have effect on 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 descending colon, the inferior mesenteric artery and vein are high lighted. The sigmoid colon is removed from the middle portion. Then the perineal phase is done and throws intersphincter groove complex of ithe nternal anal sphincter and the rectum and distal sigmoid are resect then end to end coloanal anastomosis using PDS 3.0 will be done. At the same time, an appendicostomy is inserted for the patient.T o do this, the appendix is dissected and the longitudinal incision of the distal appendices is done, then, in right lower quadrant skin U shape incision is performed and anti mesenteric edges are sutured to the skin with 4-0 absorbable. A small catheter is placed in the appendicostomy for a week and the first antegrade enema with one litre of water is done. The necessary care and method of using appendicostomy is given to patients before discharge.</i_keyword>
      <i_keyword>Control group: without appnndicostomy: first, after the release of the descending colon, the inferior mesenteric artery and vein are high lighted. The sigmoid colon is removed from the middle portion. Then the perineal phase is done and throws intersphincter groove complex of the internal anal sphincter and the rectum and distal sigmoid are resect then end to end coloanal anastomosis using PDS 3.0 will be done.</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 questionnaire. 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>2016-11-02</approval_date>
        <contact_name>Ethics committee of Mazandaran 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>
