<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02997267</url>
  </required_header>
  <id_info>
    <org_study_id>Zespolenia</org_study_id>
    <nct_id>NCT02997267</nct_id>
  </id_info>
  <brief_title>Early Closure of Protective Ileostomy in Rectal Cancer Patients</brief_title>
  <acronym>ECPIS</acronym>
  <official_title>The Early Closure of the Protective Ileostomy After Low Anterior Resection Enables Correct Start of Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanley Dudrick's Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanley Dudrick's Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to compare the restoration of the GI tract by the closure of&#xD;
      protective ileostomy after low anterior resection for rectal cancer after 14 days and more&#xD;
      than 3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The closure of the protective ileostomy created during the low anterior resection for rectal&#xD;
      cancer to protect the colo-rectal anastomosis is inevitable to restore the continuity of the&#xD;
      gastrointestinal tract. It usually takes place several months after the primary surgery,&#xD;
      because the patients starts chemotherapy and cannot undergo the procedure during the therapy.&#xD;
      It results in the relative low quality of life of the patient, as well as often leads to&#xD;
      complications. Therefore, it seem reasonable to close the stoma as soon as possible to take&#xD;
      the burden off patient.&#xD;
&#xD;
      It is well known that the healing process of the anastomosis runs in the three phases, but&#xD;
      only two first are crucial for the clinical result. The second takes place between 5th and&#xD;
      14th postoperative day. Therefore it should be possible to perform successful restoration of&#xD;
      the GI tract already after two weeks after operation, and not after many moths.&#xD;
&#xD;
      The aim of the study was to compare the restoration of the GI tract after 14 days and more&#xD;
      than 3 months, so to compare the traditional and early strategy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of postoperative fistulas</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>number of patients with the fistula of the anastomosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timing of anticancer therapy</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Time to the beginning of adiuvant chemotherapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Ileostomy - Stoma</condition>
  <arm_group>
    <arm_group_label>Early closure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Closure of the ileostomy 14 days after the primary operation, in which it was created.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Closure of the ileostomy more than 90 days after the primary operation, in which it was created.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Closure of the ileostomy</intervention_name>
    <description>Surgical closure of the protective ileostomy (reconnection of intestinal loops)</description>
    <arm_group_label>Early closure</arm_group_label>
    <arm_group_label>Late closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  more than 18 year old&#xD;
&#xD;
          -  the presence of the protective ileostomy created during the low anterior resection to&#xD;
             protect the colo-rectal anastomosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the presence of the protective ileostomy created during any other procedure than the&#xD;
             low anterior resection to protect the colo-rectal anastomosis&#xD;
&#xD;
          -  age &lt; 18 yo&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanley Dudrick's Memorial Hospital</name>
      <address>
        <city>Skawina</city>
        <zip>32-050</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>March 31, 2018</last_update_submitted>
  <last_update_submitted_qc>March 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanley Dudrick's Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Stanislaw Klek</investigator_full_name>
    <investigator_title>Head of the Department</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data (IPD) available to other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02997267
org study id: Zespolenia
nct id: NCT02997267
lead sponsor: 
has dmc: No
The aim of the study was to compare the restoration of the GI tract by the closure of
      protective ileostomy after low anterior resection for rectal cancer after 14 days and more
      than 3 months.
The closure of the protective ileostomy created during the low anterior resection for rectal
      cancer to protect the colo-rectal anastomosis is inevitable to restore the continuity of the
      gastrointestinal tract. It usually takes place several months after the primary surgery,
      because the patients starts chemotherapy and cannot undergo the procedure during the therapy.
      It results in the relative low quality of life of the patient, as well as often leads to
      complications. Therefore, it seem reasonable to close the stoma as soon as possible to take
      the burden off patient.

      It is well known that the healing process of the anastomosis runs in the three phases, but
      only two first are crucial for the clinical result. The second takes place between 5th and
      14th postoperative day. Therefore it should be possible to perform successful restoration of
      the GI tract already after two weeks after operation, and not after many moths.

      The aim of the study was to compare the restoration of the GI tract after 14 days and more
      than 3 months, so to compare the traditional and early strategy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of postoperative fistulas
time frame: 3 months after surgery
description: number of patients with the fistula of the anastomosis
measure: Timing of anticancer therapy
time frame: 3 months after surgery
description: Time to the beginning of adiuvant chemotherapy
arm group label: Early closure
arm group type: Experimental
description: Closure of the ileostomy 14 days after the primary operation, in which it was created.
arm group label: Late closure
arm group type: Active Comparator
description: Closure of the ileostomy more than 90 days after the primary operation, in which it was created.
intervention type: Procedure
intervention name: Closure of the ileostomy
description: Surgical closure of the protective ileostomy (reconnection of intestinal loops)
arm group label: Early closure
arm group label: Late closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Stanley Dudrick's Memorial Hospital
investigator full name: Stanislaw Klek
investigator title: Head of the Department
sharing ipd: No
ipd description: There is no plan to make individual participant data (IPD) available to other researchers.