<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/NCT03799939</url>
  </required_header>
  <id_info>
    <org_study_id>305/2018</org_study_id>
    <nct_id>NCT03799939</nct_id>
  </id_info>
  <brief_title>Chimney Trial of Parastomal Hernia Prevention</brief_title>
  <official_title>Chimney Trial - Randomized, Controlled, Multi Center Trial of Parastomal Hernia Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oulu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oulu</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chimney trial is designed to compare the effectiveness and safety of specifically designated&#xD;
      polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized&#xD;
      setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy&#xD;
      is made. The results of previous trials using keyhole technique are partially unsatisfactory.&#xD;
      Specifically designed PVDF mesh used in this trial showed promising results in previous small&#xD;
      trial.&#xD;
&#xD;
      Chimney trial is designed to compare the effectiveness and safety of mesh group to controls&#xD;
      operated with no preventive mesh in parastomal hernia prevention after laparoscopic or&#xD;
      robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal&#xD;
      adenocarcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Anticipated">July 2022</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>
    <intervention_model_description>Chimney trial is a prospective randomized controlled multicenter trial.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants are unaware of the randomization group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of parastomal hernia</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence of parastomal hernia at 12 months follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of parastomal hernia at long term follow up</measure>
    <time_frame>5 years</time_frame>
    <description>Incidence of parastomal hernia during 5 years of follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical site infection rate</measure>
    <time_frame>30 days</time_frame>
    <description>Surgical site infections measured by Clavien-Dindo Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>30 days</time_frame>
    <description>Complications measured by Clavien-Dindo Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stoma related complications</measure>
    <time_frame>5 years</time_frame>
    <description>Stoma related complications measured by Clavien-Dindo Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reoperation rate</measure>
    <time_frame>5 years</time_frame>
    <description>Need for reoperations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>1 day</time_frame>
    <description>Operative time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>30 days</time_frame>
    <description>Length of stay at the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rand 36 quality of life</measure>
    <time_frame>5 years</time_frame>
    <description>Quality of life measured by Rand-36 quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by Colostomy impact score</measure>
    <time_frame>5 years</time_frame>
    <description>Quality of life measured by Colostomy impact score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medico-economic substudy</measure>
    <time_frame>5 years</time_frame>
    <description>Medico-economic substudy including both short and long term costs included in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological substudy of stoma distance</measure>
    <time_frame>3 years</time_frame>
    <description>Distance of stoma from midline defined by umbilicus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological substudy of adipose tissue thickness</measure>
    <time_frame>3 years</time_frame>
    <description>Thickness of adipose tissue on computer tomography scan on contralateral site of stoma</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>Parastomal Hernia</condition>
  <condition>Rectal Adenocarcinoma</condition>
  <condition>Abdominoperineal Resection</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Polyvinylidene fluoride mesh used in this trial (Dynamesh IPST) is synthetic mesh with central tube to accommodate bowel tightly and designed to prevent and treat parastomal hernia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in control group are operated with no preventive mesh.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intervention group</intervention_name>
    <description>Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Rectal adenocarcinoma with curative intent laparoscopic or robotic assisted&#xD;
             abdominoperineal resection or low Hartmann´s operation and permanent colostomy&#xD;
&#xD;
          -  Patient has a life expectancy of at least 12 months.&#xD;
&#xD;
          -  Patient must sign Informed consent before any study procedures and agrees to attend&#xD;
             all study visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to&#xD;
             laparotomy&#xD;
&#xD;
          -  Complication requiring laparotomy during post surgery treatment at surgical ward after&#xD;
             APR&#xD;
&#xD;
          -  Patient with a comorbid illness or condition that would preclude the use of surgery&#xD;
             (ASA 4-5).&#xD;
&#xD;
          -  Patients with concurrent or previous malignant tumors within 5 years before study&#xD;
             enrollment&#xD;
&#xD;
          -  Patients with T4b tumors which impose a multi-organ resection&#xD;
&#xD;
          -  Rectal malignancy other than adenocarcinoma&#xD;
&#xD;
          -  Patient undergoing emergency procedures&#xD;
&#xD;
          -  Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies,&#xD;
             other intestinal resections).&#xD;
&#xD;
          -  Metastatic disease with no possibility of curative surgery&#xD;
&#xD;
          -  Pregnant or suspected pregnancy&#xD;
&#xD;
          -  Patients living geographically distant and/or unwilling to return for follow-ups or&#xD;
             comply with all study requirements&#xD;
&#xD;
          -  Active abdominal infection at the time of surgery&#xD;
&#xD;
          -  Previous surgery at the colostomy site&#xD;
&#xD;
          -  Language barrier or other reasons why informed consent is not possible&#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>Elisa Mäkäräinen-Uhlbäck, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oulu University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keski-Suomi Central Hospital</name>
      <address>
        <city>Jyväskylä</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oulu University Hospital</name>
      <address>
        <city>Oulu</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seinäjoki Central Hospital</name>
      <address>
        <city>Seinäjoki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maziar Nikberg</name>
      <address>
        <city>Västerås</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>August 10, 2021</last_update_submitted>
  <last_update_submitted_qc>August 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oulu</investigator_affiliation>
    <investigator_full_name>Elisa Makarainen-Uhlback</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03799939
org study id: 305/2018
nct id: NCT03799939
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chimney trial is designed to compare the effectiveness and safety of specifically designated
      polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized
      setting.
The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy
      is made. The results of previous trials using keyhole technique are partially unsatisfactory.
      Specifically designed PVDF mesh used in this trial showed promising results in previous small
      trial.

      Chimney trial is designed to compare the effectiveness and safety of mesh group to controls
      operated with no preventive mesh in parastomal hernia prevention after laparoscopic or
      robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal
      adenocarcinoma.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Chimney trial is a prospective randomized controlled multicenter trial.
primary purpose: Prevention
masking: Single (Participant)
masking description: Participants are unaware of the randomization group.
measure: Incidence of parastomal hernia
time frame: 12 months
description: Incidence of parastomal hernia at 12 months follow up
measure: Incidence of parastomal hernia at long term follow up
time frame: 5 years
description: Incidence of parastomal hernia during 5 years of follow up
measure: Surgical site infection rate
time frame: 30 days
description: Surgical site infections measured by Clavien-Dindo Classification
measure: Complications
time frame: 30 days
description: Complications measured by Clavien-Dindo Classification
measure: Stoma related complications
time frame: 5 years
description: Stoma related complications measured by Clavien-Dindo Classification
measure: Reoperation rate
time frame: 5 years
description: Need for reoperations
measure: Operative time
time frame: 1 day
description: Operative time
measure: Length of stay
time frame: 30 days
description: Length of stay at the hospital
measure: Rand 36 quality of life
time frame: 5 years
description: Quality of life measured by Rand-36 quality of life questionnaire
measure: Quality of life measured by Colostomy impact score
time frame: 5 years
description: Quality of life measured by Colostomy impact score
measure: Medico-economic substudy
time frame: 5 years
description: Medico-economic substudy including both short and long term costs included in both groups
measure: Radiological substudy of stoma distance
time frame: 3 years
description: Distance of stoma from midline defined by umbilicus
measure: Radiological substudy of adipose tissue thickness
time frame: 3 years
description: Thickness of adipose tissue on computer tomography scan on contralateral site of stoma
arm group label: Intervention group
arm group type: Active Comparator
description: Polyvinylidene fluoride mesh used in this trial (Dynamesh IPST) is synthetic mesh with central tube to accommodate bowel tightly and designed to prevent and treat parastomal hernia.
arm group label: Control group
arm group type: No Intervention
description: Participants in control group are operated with no preventive mesh.
intervention type: Device
intervention name: Intervention group
description: Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elisa Mäkäräinen-Uhlbäck, M.D.
role: Principal Investigator
affiliation: Oulu University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Finland
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: University of Oulu
investigator full name: Elisa Makarainen-Uhlback
investigator title: Principal Investigator
mesh term: Hernia
sharing ipd: No