<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/NCT03796702</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03796702</nct_id>
  </id_info>
  <brief_title>Early Versus Late Closure of Preventive Ileostomy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vilnius University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vilnius University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed and performed as a prospective randomized controlled single-center&#xD;
      study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer&#xD;
      will be included. The study investigates the effect of reversing a temporary ileostomy after&#xD;
      30 vs 90 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    High postoperative morbidity rate&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2011</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative morbidity</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalization time after ileostomy closure</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Hospitalization time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-days re-admission rate</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Re-admission rate during 30 days after re-admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of patients after ileostomy closure</measure>
    <time_frame>at 3, 6, 9 and 12 moths after surgery</time_frame>
    <description>Patients quality of life is assessed with EORTC QLQ-C30 questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Ileostomy, Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Early closure of preventive ileostomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A preventive ileostomy is closed 30 days after the primary surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late closure of preventive ileostomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A preventive ileostomy is closed 90 days after the primary surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deileostomy</intervention_name>
    <description>Deileostomy</description>
    <arm_group_label>Early closure of preventive ileostomy</arm_group_label>
    <arm_group_label>Late closure of preventive ileostomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with temporary ileostomy after rectal resection for rectal cancer&#xD;
&#xD;
          -  Patients willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anastomosis insufficiency detected clinically or radiologically.&#xD;
&#xD;
          -  Patients, who are physically and mentally unfit to undergo surgery or to be&#xD;
             followed-up&#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>National Cancer Institute</name>
      <address>
        <city>Vilnius</city>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lithuania</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vilnius University</investigator_affiliation>
    <investigator_full_name>Rimantas Bausys</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03796702
org study id: 1
nct id: NCT03796702
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is designed and performed as a prospective randomized controlled single-center
      study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer
      will be included. The study investigates the effect of reversing a temporary ileostomy after
      30 vs 90 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Postoperative morbidity
time frame: 30 days after surgery
description: Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
measure: Hospitalization time after ileostomy closure
time frame: 30 days after surgery
description: Hospitalization time
measure: 30-days re-admission rate
time frame: 30 days after surgery
description: Re-admission rate during 30 days after re-admission
measure: Quality of life of patients after ileostomy closure
time frame: at 3, 6, 9 and 12 moths after surgery
description: Patients quality of life is assessed with EORTC QLQ-C30 questionnaires
arm group label: Early closure of preventive ileostomy
arm group type: Experimental
description: A preventive ileostomy is closed 30 days after the primary surgery
arm group label: Late closure of preventive ileostomy
arm group type: Experimental
description: A preventive ileostomy is closed 90 days after the primary surgery
intervention type: Procedure
intervention name: Deileostomy
description: Deileostomy
arm group label: Early closure of preventive ileostomy
arm group label: Late closure of preventive ileostomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Lithuania
responsible party type: Principal Investigator
investigator affiliation: Vilnius University
investigator full name: Rimantas Bausys
investigator title: Investigator
mesh term: Rectal Neoplasms
sharing ipd: Undecided