<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/NCT03795766</url>
  </required_header>
  <id_info>
    <org_study_id>GY-PONV</org_study_id>
    <nct_id>NCT03795766</nct_id>
  </id_info>
  <brief_title>Nausea and Vomiting After Gynecologic Surgery</brief_title>
  <official_title>Prevalence and Predictors of Nausea and Vomiting After Gynecologic Surgery: a Cross-section Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      In this cross-section study, all patients in the gynecologic ward of Peking Union Medical&#xD;
      College Hospital will accepted a survey about the prevalence and severity of nausea and&#xD;
      vomiting according to visual analogue scale and WHO classification. Epidemiological,&#xD;
      surgical, anaesthetic characteristics and post-operative treatment are considered as&#xD;
      predictors for the post-operative nausea and vomiting. The primary objective is the incidence&#xD;
      of nausea and vomiting. The secondary objective is the possible predictors of nausea and&#xD;
      vomiting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>Incidence of post-operative nausea and vomiting</measure>
    <time_frame>72 hours post-operative</time_frame>
    <description>Incidence of post-operative nausea and vomiting</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of post-operative nausea and vomiting by visual analogue scale</measure>
    <time_frame>72 hours post-operative</time_frame>
    <description>Severity of post-operative nausea and vomiting according to the visual analogue scale. In th scale, 0 denotes none, 10 denotes the most severe conditions. The scale will be judged by the patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of post-operative nausea and vomiting by World Health Organization classification</measure>
    <time_frame>72 hours post-operative</time_frame>
    <description>Severity of post-operative nausea and vomiting according to World Health Organization (WHO) classification. In WHO classfication, I denotes none, II, III and IV denote mild, moderate and severe conditions.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Postoperative Nausea and Vomiting</condition>
  <condition>Gynecologic Surgery</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgeries for gynecologic disease</intervention_name>
    <description>All patients accept surgeries for gynecologic disease.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients accept elective surgeries for gynecologic disease with good performance&#xD;
        status.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  Elective surgeries for gynecologic disease&#xD;
&#xD;
          -  Good performance status&#xD;
&#xD;
          -  Signed an approved informed consents&#xD;
&#xD;
          -  Post-operative stay 72 hours or longer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgeries&#xD;
&#xD;
          -  Not meeting all of the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lei Li, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Li</last_name>
    <phone>+8613911988831</phone>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei Li, MD</last_name>
      <phone>008613911988831</phone>
      <email>lileigh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lei Li</investigator_full_name>
    <investigator_title>Professor</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 Nausea and Vomiting</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03795766
org study id: GY-PONV
nct id: NCT03795766
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this cross-section study, all patients in the gynecologic ward of Peking Union Medical
      College Hospital will accepted a survey about the prevalence and severity of nausea and
      vomiting according to visual analogue scale and WHO classification. Epidemiological,
      surgical, anaesthetic characteristics and post-operative treatment are considered as
      predictors for the post-operative nausea and vomiting. The primary objective is the incidence
      of nausea and vomiting. The secondary objective is the possible predictors of nausea and
      vomiting.
observational model: Cohort
time perspective: Prospective
measure: Incidence of post-operative nausea and vomiting
time frame: 72 hours post-operative
description: Incidence of post-operative nausea and vomiting
measure: Severity of post-operative nausea and vomiting by visual analogue scale
time frame: 72 hours post-operative
description: Severity of post-operative nausea and vomiting according to the visual analogue scale. In th scale, 0 denotes none, 10 denotes the most severe conditions. The scale will be judged by the patients.
measure: Severity of post-operative nausea and vomiting by World Health Organization classification
time frame: 72 hours post-operative
description: Severity of post-operative nausea and vomiting according to World Health Organization (WHO) classification. In WHO classfication, I denotes none, II, III and IV denote mild, moderate and severe conditions.
intervention type: Procedure
intervention name: Surgeries for gynecologic disease
description: All patients accept surgeries for gynecologic disease.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lei Li, M.D.
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Lei Li
phone: +8613911988831
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lei Li
investigator title: Professor
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
sharing ipd: Undecided