<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/NCT04449822</url>
  </required_header>
  <id_info>
    <org_study_id>07122017</org_study_id>
    <nct_id>NCT04449822</nct_id>
  </id_info>
  <brief_title>Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions</brief_title>
  <official_title>Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zaza Demetrashvili</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tbilisi State Medical 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 evaluates and compares effect of emergency surgery and colonic stents for treatment&#xD;
      of malignant colonic obstructions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute colonic obstruction is one of the common clinical presentations of colorectal cancer.&#xD;
      Surgical decompression with colostomy with or without resection and eventual re-anastomosis&#xD;
      is the treatment of choice; however, emergency surgery is associated with higher morbidity&#xD;
      and mortality.&#xD;
&#xD;
      The colonic stent insertion effectively decompressed the obstructed colon and avoid needs of&#xD;
      emergency surgery. This method is a palliation and bridge to surgery. Colonic stents allowed&#xD;
      surgery to be performed electively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2017</start_date>
  <completion_date type="Actual">March 5, 2022</completion_date>
  <primary_completion_date type="Actual">December 5, 2021</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>The time of clinical relieve of obstruction</measure>
    <time_frame>24 hours after surgery/procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stent related complications</measure>
    <time_frame>time of hospital stay, an average 10 day.</time_frame>
    <description>perforation, migration, stent obstruction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 day after surgery/procedure</time_frame>
    <description>30-day mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>time of surgery/procedure</time_frame>
    <description>Blood loss during emergency surgery or during colonic stenting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operation time</measure>
    <time_frame>during surgery/procedure</time_frame>
    <description>duration of surgery/procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall complications</measure>
    <time_frame>30 day after surgery/procedure</time_frame>
    <description>complications which developed in postoperative period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Emergency surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical decompression with colostomy with or without resection and eventual re-anastomosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colonic stenting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The colonic stent placement</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Emergency surgery</intervention_name>
    <description>Surgical decompression with colostomy with or without resection and eventual re-anastomosis.</description>
    <arm_group_label>Emergency surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Colonic stenting</intervention_name>
    <description>The colonic stent placement to relieve the colonic obstruction.</description>
    <arm_group_label>Colonic stenting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with malignant colorectal obstructions.&#xD;
&#xD;
          -  Patient's approval to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's preference for either treatment method.&#xD;
&#xD;
          -  Patient's refusal to participate in the study.&#xD;
&#xD;
          -  Patients in the ASA group 4 and 5.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zaza Demetrashvili</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tbilisi State Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tbilisi State Medical University</name>
      <address>
        <city>Tbilisi</city>
        <state>Yes</state>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Georgia</country>
  </location_countries>
  <results_reference>
    <citation>Merabishvili G, Agdgomelashvili I, Mosidze B, Demetrashvili Z. Emergency surgery versus colorectal stenting for the management of left-sided malignant colon obstructions:A prospective cohort study. Acta Scientific Medical Sciences 2021, 5(4):18-23. doi: 10.31080/ASMS.2020.05.0863</citation>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tbilisi State Medical University</investigator_affiliation>
    <investigator_full_name>Zaza Demetrashvili</investigator_full_name>
    <investigator_title>Associate Professor, Surgery Department</investigator_title>
  </responsible_party>
  <keyword>Hartmann's procedure, colostomy, colonic stenting.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- 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/NCT04449822
org study id: 07122017
nct id: NCT04449822
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study evaluates and compares effect of emergency surgery and colonic stents for treatment
      of malignant colonic obstructions.
Acute colonic obstruction is one of the common clinical presentations of colorectal cancer.
      Surgical decompression with colostomy with or without resection and eventual re-anastomosis
      is the treatment of choice; however, emergency surgery is associated with higher morbidity
      and mortality.

      The colonic stent insertion effectively decompressed the obstructed colon and avoid needs of
      emergency surgery. This method is a palliation and bridge to surgery. Colonic stents allowed
      surgery to be performed electively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The time of clinical relieve of obstruction
time frame: 24 hours after surgery/procedure
measure: Stent related complications
time frame: time of hospital stay, an average 10 day.
description: perforation, migration, stent obstruction
measure: Mortality
time frame: 30 day after surgery/procedure
description: 30-day mortality
measure: Blood loss
time frame: time of surgery/procedure
description: Blood loss during emergency surgery or during colonic stenting.
measure: operation time
time frame: during surgery/procedure
description: duration of surgery/procedure
measure: Overall complications
time frame: 30 day after surgery/procedure
description: complications which developed in postoperative period
arm group label: Emergency surgery
arm group type: Active Comparator
description: Surgical decompression with colostomy with or without resection and eventual re-anastomosis.
arm group label: Colonic stenting
arm group type: Active Comparator
description: The colonic stent placement
intervention type: Procedure
intervention name: Emergency surgery
description: Surgical decompression with colostomy with or without resection and eventual re-anastomosis.
arm group label: Emergency surgery
intervention type: Procedure
intervention name: Colonic stenting
description: The colonic stent placement to relieve the colonic obstruction.
arm group label: Colonic stenting
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zaza Demetrashvili
role: Principal Investigator
affiliation: Tbilisi State Medical University
facility: 
country: Georgia
citation: Merabishvili G, Agdgomelashvili I, Mosidze B, Demetrashvili Z. Emergency surgery versus colorectal stenting for the management of left-sided malignant colon obstructions:A prospective cohort study. Acta Scientific Medical Sciences 2021, 5(4):18-23. doi: 10.31080/ASMS.2020.05.0863
responsible party type: Sponsor-Investigator
investigator affiliation: Tbilisi State Medical University
investigator full name: Zaza Demetrashvili
investigator title: Associate Professor, Surgery Department
mesh term: Emergencies