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/NCT05994326</url>
    </required_header>
    <id_info>
      <org_study_id>Dnr: 2019-03867</org_study_id>
      <nct_id>NCT05994326</nct_id>
    </id_info>
    <brief_title>Perioperative Care and Short-term Outcomes of Colorectal Surgery in Addis Abeba</brief_title>
    <official_title>Perioperative Care and Short-term Outcomes of Colorectal Surgery: A Prospective Study From Tikur Anbessa Specialized Hospital in Addis Abeba Ethiopia</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>
        Observational cohort study of adult patients undergoing colorectal surgery at Tikur Anbessa&#xD;
        Specialized Hospital in Addis Abeba for 3 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Observational prospective cohort study, including all adult (≥18) patients undergoing&#xD;
        colorectal surgery at Tikur Anbessa Specialized Hospital in Addis Abeba for 3 months.&#xD;
        Variables are patients' characteristics, risk factors, investigations, types of operations,&#xD;
        level of training of surgeon, and postoperative management. The data collection is conducted&#xD;
        at admission, day of surgery, and discharge. The primary outcomes are in-hospital&#xD;
        complications and length of stay, and the secondary outcomes are perioperative management.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 12, 2022</start_date>
    <completion_date type="Actual">December 11, 2022</completion_date>
    <primary_completion_date type="Actual">December 11, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion postoperative complications</measure>
      <time_frame>From date of surgery to date of discharge from hospital or maximun 30 days postoperatively</time_frame>
      <description>Number and proportion (%) of patients with any postoperative complication according to Clavien-Dindo</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean length of stay</measure>
      <time_frame>From admission to date of discharge from hospital, up to 30 days</time_frame>
      <description>Mean number of days in hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Type of surgery performed</measure>
      <time_frame>From admission to date of discharge from hospital, up to 30 days</time_frame>
      <description>Number and proportion (%) of colorectal operations performed (colectomy, rectal resection, stoma without resection)</description>
    </secondary_outcome>
    <enrollment type="Actual">47</enrollment>
    <condition>Colorectal Disorders</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients (≥18 years) with willingness and ability to give informed consent, who were&#xD;
          admitted to the surgical department at TASH (elective or in an emergency) and operated for&#xD;
          a colorectal condition&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  Willingness and ability to give informed consent&#xD;
  &#xD;
            -  Admitted to the surgical department at TASH (elective or in an emergency) and operated&#xD;
               for a colorectal condition&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -Emergency conditions usually managed in general surgery, e.g., perianal conditions and&#xD;
          adhesive small bowel obstruction&#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 Ababa</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>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 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/NCT05994326
  org study id: Dnr: 2019-03867
  nct id: NCT05994326
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Observational cohort study of adult patients undergoing colorectal surgery at Tikur Anbessa
        Specialized Hospital in Addis Abeba for 3 months.
  Observational prospective cohort study, including all adult (≥18) patients undergoing
        colorectal surgery at Tikur Anbessa Specialized Hospital in Addis Abeba for 3 months.
        Variables are patients' characteristics, risk factors, investigations, types of operations,
        level of training of surgeon, and postoperative management. The data collection is conducted
        at admission, day of surgery, and discharge. The primary outcomes are in-hospital
        complications and length of stay, and the secondary outcomes are perioperative management.
  observational model: Cohort
  time perspective: Prospective
  measure: Proportion postoperative complications
  time frame: From date of surgery to date of discharge from hospital or maximun 30 days postoperatively
  description: Number and proportion (%) of patients with any postoperative complication according to Clavien-Dindo
  measure: Mean length of stay
  time frame: From admission to date of discharge from hospital, up to 30 days
  description: Mean number of days in hospital
  measure: Type of surgery performed
  time frame: From admission to date of discharge from hospital, up to 30 days
  description: Number and proportion (%) of colorectal operations performed (colectomy, rectal resection, stoma without resection)
  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