<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/NCT04433676</url>
  </required_header>
  <id_info>
    <org_study_id>SPOR-PONV 1.0</org_study_id>
    <nct_id>NCT04433676</nct_id>
  </id_info>
  <brief_title>Early PONV - a Registry Based Study in Sweden.</brief_title>
  <acronym>SPOR-PONV</acronym>
  <official_title>Risk of Early Postoperative Nausea and Vomiting (PONV) - a Study With Data From the Swedish Perioperative Register (SPOR).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jakob Wallden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Umeå University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Västernorrland County Council, Sweden</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>
      The study is an registry study based on data from the Swedish Perioperative Registry (SPOR)&#xD;
      during the years 2016-2022 with the aim to explore the risk for postoperative nausea and&#xD;
      vomiting at the recovery unit (early PONV). The study will explore several cohorts (for&#xD;
      example a specific procedure) on a national basis, report the risk for early PONV and&#xD;
      identify associated factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a registry study based on data from the Swedish Perioperative Registry (SPOR)&#xD;
      during the years 2016-2022 with the aim to explore the risk for postoperative nausea and&#xD;
      vomiting at the recovery unit (early PONV).&#xD;
&#xD;
      Almost all hospitals in Sweden report surgical procedures to SPOR and for the years 2016-2019&#xD;
      there are almost 1.7 million procedures in the registry for patients &gt;18years. Data will be&#xD;
      extracted from SPOR on a yearly basis and results will be reported on selected cohorts (time&#xD;
      periods and/or type of surgical procedure) during the study period.&#xD;
&#xD;
      There is an option for hospitals to register nausea and vomiting occurring at the recovery&#xD;
      unit and submit the data to SPOR. If a hospital choose to use the variable in their dataset,&#xD;
      all patients at their unit needs to be registered either with [No_Nausea or Vomiting],&#xD;
      [Nausea] or [Nausea or Vomiting]. In the year 2019, more than 50% of procedures under&#xD;
      anesthesia in the registry had registration of PONV. The strength with this system is that if&#xD;
      a unit uses the variable, all cases will be classified either as &quot;noPONV&quot; or &quot;PONV&quot;.&#xD;
&#xD;
      The investigators aim to use the variable PONV at the recovery unit to describe the risk for&#xD;
      early PONV and explore associated factors in several cohorts of surgical procedures in&#xD;
      Sweden.&#xD;
&#xD;
      The first dataset (2016-2018) was sent to the investigators from the SPOR registry in May&#xD;
      2019 and during the period June 2019- May 2020, the dataset was used to build up a model for&#xD;
      the analysis of data with a preliminary report of elective surgeries in Sweden the year 2017.&#xD;
&#xD;
      An updated dataset (all cases 2016-2019) was retrieved from SPOR on June 3 2020 and further&#xD;
      analysis and reporting is based on the most updated dataset (yearly basis).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>PONV</measure>
    <time_frame>At the recovery unit, up to 24 hours after surgery.</time_frame>
    <description>Nausea or Vomiting</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1500000</enrollment>
  <condition>Postoperative Nausea and Vomiting</condition>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Patients with surgical procedures</arm_group_label>
    <description>Adult patients undergoing surgical procedures under general or regional anesthesia and with an admission to a recovery unit for the initial postoperative care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <arm_group_label>Patients with surgical procedures</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Registry data of patients with surgical procedures under general or regional anesthesia in&#xD;
        Sweden 2016-2022.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Procedure under general or regional anaesthesia&#xD;
&#xD;
          -  Age &gt;=18 years at the day of the procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No entry of the PONV-variable in the SPOR-registry&#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>Jakob Wallden, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Västernorrland (Västernorrland County Council)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jakob Wallden, MD PhD</last_name>
    <phone>0046703644392</phone>
    <email>jakob.wallden@umu.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Västernorrland County Council / Sundsvall Hospital</name>
      <address>
        <city>Sundsvall</city>
        <state>X</state>
        <zip>851 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jakob Wallden, M.D. PhD.</last_name>
      <phone>+46703644392</phone>
      <email>jakob.wallden@umu.se</email>
    </contact>
    <contact_backup>
      <last_name>Antonio Moraitis, M.D. Ph.D.</last_name>
      <email>antonio.moraitis@rvn.se</email>
    </contact_backup>
    <investigator>
      <last_name>Jakob Wallden, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Antonio Moraitis, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Helena Nyström, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Magnus Hultin, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jenny Jonsson</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 14, 2020</last_update_submitted>
  <last_update_submitted_qc>June 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Västernorrland County Council, Sweden</investigator_affiliation>
    <investigator_full_name>Jakob Wallden</investigator_full_name>
    <investigator_title>Senior Lecturer, Consultant Anesthesiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Our dataset includes a large set of registry data, and we are not sure if we legally are allowed to share these data.</ipd_description>
  </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/NCT04433676
org study id: SPOR-PONV 1.0
nct id: NCT04433676
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is an registry study based on data from the Swedish Perioperative Registry (SPOR)
      during the years 2016-2022 with the aim to explore the risk for postoperative nausea and
      vomiting at the recovery unit (early PONV). The study will explore several cohorts (for
      example a specific procedure) on a national basis, report the risk for early PONV and
      identify associated factors.
The study is a registry study based on data from the Swedish Perioperative Registry (SPOR)
      during the years 2016-2022 with the aim to explore the risk for postoperative nausea and
      vomiting at the recovery unit (early PONV).

      Almost all hospitals in Sweden report surgical procedures to SPOR and for the years 2016-2019
      there are almost 1.7 million procedures in the registry for patients >18years. Data will be
      extracted from SPOR on a yearly basis and results will be reported on selected cohorts (time
      periods and/or type of surgical procedure) during the study period.

      There is an option for hospitals to register nausea and vomiting occurring at the recovery
      unit and submit the data to SPOR. If a hospital choose to use the variable in their dataset,
      all patients at their unit needs to be registered either with [No_Nausea or Vomiting],
      [Nausea] or [Nausea or Vomiting]. In the year 2019, more than 50% of procedures under
      anesthesia in the registry had registration of PONV. The strength with this system is that if
      a unit uses the variable, all cases will be classified either as "noPONV" or "PONV".

      The investigators aim to use the variable PONV at the recovery unit to describe the risk for
      early PONV and explore associated factors in several cohorts of surgical procedures in
      Sweden.

      The first dataset (2016-2018) was sent to the investigators from the SPOR registry in May
      2019 and during the period June 2019- May 2020, the dataset was used to build up a model for
      the analysis of data with a preliminary report of elective surgeries in Sweden the year 2017.

      An updated dataset (all cases 2016-2019) was retrieved from SPOR on June 3 2020 and further
      analysis and reporting is based on the most updated dataset (yearly basis).
observational model: Cohort
time perspective: Other
measure: PONV
time frame: At the recovery unit, up to 24 hours after surgery.
description: Nausea or Vomiting
arm group label: Patients with surgical procedures
description: Adult patients undergoing surgical procedures under general or regional anesthesia and with an admission to a recovery unit for the initial postoperative care.
intervention type: Other
intervention name: no intervention
arm group label: Patients with surgical procedures
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jakob Wallden, MD PhD
role: Principal Investigator
affiliation: Region Västernorrland (Västernorrland County Council)
last name: Jakob Wallden, MD PhD
phone: 0046703644392
email: jakob.wallden@umu.se
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Västernorrland County Council, Sweden
investigator full name: Jakob Wallden
investigator title: Senior Lecturer, Consultant Anesthesiologist
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Complications
mesh term: Postoperative Nausea and Vomiting
sharing ipd: Undecided
ipd description: Our dataset includes a large set of registry data, and we are not sure if we legally are allowed to share these data.