xml: <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/NCT05970458</url>
    </required_header>
    <id_info>
      <org_study_id>008/21/Surg</org_study_id>
      <nct_id>NCT05970458</nct_id>
    </id_info>
    <brief_title>Stoma Related Complications and Quality of Life Assessments Ethiopia and Sweden</brief_title>
    <official_title>Stoma Related Complications and Quality of Life Assessment: a Cross-sectional Study With Patients From Ethiopia and Sweden</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karolinska Institutet</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karolinska Institutet</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>
        Cross-sectional comparative study of general and stoma-specific quality of life in patients&#xD;
        with stoma in Addis Abeba, Ethiopia, and Stockholm, Sweden.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: To evaluate the quality of life for patients with ostomy in Ethiopia and Sweden&#xD;
        using a general and a specific assessment tool.&#xD;
  &#xD;
        Design: Comparative descriptive cross-sectional study. Setting: Tikur Anbessa Specialized&#xD;
        Hospital (TASH), Addis Abeba and South General Hospital, Stockholm.&#xD;
  &#xD;
        Participants/Exposure: Patients with a permanent ostomy visiting the stoma center in Addis&#xD;
        Abeba, patients waiting for ostomy reversal at TASH, and patients visiting the stoma clinic&#xD;
        at South General Hospital.&#xD;
  &#xD;
        Main outcomes and measure: Quality of life and stoma specific quality of life: EQ5D-5L and&#xD;
        Stoma QoL.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Actual">January 30, 2023</completion_date>
    <primary_completion_date type="Actual">January 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>General quality of life</measure>
      <time_frame>October 2022 to Jan 2023</time_frame>
      <description>Overall health through visual analogue scale (VAS) from zero (the worst imaginable health) to 100 (the best imaginable health) from the European Quality of Life 5 Dimensions 5 Level Version (EQ5D-5L).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stoma-specific quality of life</measure>
      <time_frame>October 2022 to Jan 2023</time_frame>
      <description>The Stoma Quality of life questionnaire consists of 20 questions about stoma-specific aspects of quality of life where each variable is valued equally. Answers are graded in a four-point scale; 1: always, 2: sometimes, 3: rarely, and 4: not at all, with a maximum score of 80. The higher score the better QoL. To get a comparable overall result, the total score (range 20-80) can be converted to a zero to 100 score.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Stoma complications</measure>
      <time_frame>October 2022 to Jan 2023</time_frame>
      <description>Nipple necrosis, prolapse, parastomal hernia, leakage, itching, bleeding, pain</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">66</enrollment>
    <condition>Stoma Colostomy</condition>
    <condition>Stoma Ileostomy</condition>
    <arm_group>
      <arm_group_label>Ethioperm</arm_group_label>
      <description>All patients with a permanent ostomy visiting the stoma center in Addis Abeba</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EthioTemp</arm_group_label>
      <description>All patients waiting for ostomy reversal at Tikur Anbessa Specialized Hospital</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SweSto</arm_group_label>
      <description>All patients visiting the stoma clinic at South General Hospital</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Quality of life assessment</intervention_name>
      <description>EQ5D-5L and Stoma QoL</description>
      <arm_group_label>EthioTemp</arm_group_label>
      <arm_group_label>Ethioperm</arm_group_label>
      <arm_group_label>SweSto</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients (≥ 18 years old) with ileostomy or colostomy for more than two months, with&#xD;
          willingness and ability to give informed consent&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adult patients (≥ 18 years old)&#xD;
  &#xD;
            -  having an ostomy for more than two months&#xD;
  &#xD;
            -  willingness and ability to give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  non-intestinal stoma&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Åsa Everhov, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Karolinska Institutet</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tikur Anbessa Specialized Hospital</name>
        <address>
          <city>Addis Abeba</city>
          <country>Ethiopia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Ethiopia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
      <investigator_full_name>Åsa Hallqvist Everhov</investigator_full_name>
      <investigator_title>Principal Investigator, Ass professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970458
  org study id: 008/21/Surg
  nct id: NCT05970458
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cross-sectional comparative study of general and stoma-specific quality of life in patients
        with stoma in Addis Abeba, Ethiopia, and Stockholm, Sweden.
  Objective: To evaluate the quality of life for patients with ostomy in Ethiopia and Sweden
        using a general and a specific assessment tool.
  
        Design: Comparative descriptive cross-sectional study. Setting: Tikur Anbessa Specialized
        Hospital (TASH), Addis Abeba and South General Hospital, Stockholm.
  
        Participants/Exposure: Patients with a permanent ostomy visiting the stoma center in Addis
        Abeba, patients waiting for ostomy reversal at TASH, and patients visiting the stoma clinic
        at South General Hospital.
  
        Main outcomes and measure: Quality of life and stoma specific quality of life: EQ5D-5L and
        Stoma QoL.
  observational model: Ecologic or Community
  time perspective: Cross-Sectional
  measure: General quality of life
  time frame: October 2022 to Jan 2023
  description: Overall health through visual analogue scale (VAS) from zero (the worst imaginable health) to 100 (the best imaginable health) from the European Quality of Life 5 Dimensions 5 Level Version (EQ5D-5L).
  measure: Stoma-specific quality of life
  time frame: October 2022 to Jan 2023
  description: The Stoma Quality of life questionnaire consists of 20 questions about stoma-specific aspects of quality of life where each variable is valued equally. Answers are graded in a four-point scale; 1: always, 2: sometimes, 3: rarely, and 4: not at all, with a maximum score of 80. The higher score the better QoL. To get a comparable overall result, the total score (range 20-80) can be converted to a zero to 100 score.
  measure: Stoma complications
  time frame: October 2022 to Jan 2023
  description: Nipple necrosis, prolapse, parastomal hernia, leakage, itching, bleeding, pain
  arm group label: Ethioperm
  description: All patients with a permanent ostomy visiting the stoma center in Addis Abeba
  arm group label: EthioTemp
  description: All patients waiting for ostomy reversal at Tikur Anbessa Specialized Hospital
  arm group label: SweSto
  description: All patients visiting the stoma clinic at South General Hospital
  intervention type: Other
  intervention name: Quality of life assessment
  description: EQ5D-5L and Stoma QoL
  arm group label: EthioTemp
  arm group label: Ethioperm
  arm group label: SweSto
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Åsa Everhov, MD PhD
  role: Principal Investigator
  affiliation: Karolinska Institutet
  facility: 
  country: Ethiopia
  responsible party type: Principal Investigator
  investigator affiliation: Karolinska Institutet
  investigator full name: Åsa Hallqvist Everhov
  investigator title: Principal Investigator, Ass professor
  sharing ipd: No