<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/NCT03820479</url>
  </required_header>
  <id_info>
    <org_study_id>DanderydH</org_study_id>
    <nct_id>NCT03820479</nct_id>
  </id_info>
  <brief_title>A Study to Investigate Quality of Recovery up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis</brief_title>
  <official_title>An Observational Study to Investigate Quality of Recovery, the Incidence and Impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danderyd Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danderyd 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>
      SYNOPSIS Title: An observational study to investigate Quality of Recovery and the incidence&#xD;
      and impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting&#xD;
      (PDNV) and up to 7 days in females undergoing laparoscopic abdominal surgery provided&#xD;
      Apfel-score based PONV care and prophylaxis.&#xD;
&#xD;
      Study period: September 2018- September 2019&#xD;
&#xD;
      Hypothesis: When a high risk patient, Apfel-score 3 or 4, is given Apfel-score based PONV&#xD;
      care with strict adherence to PONV guidelines there should be no difference in Quality of&#xD;
      Recovery between a high-risk patient and a low-risk patient.&#xD;
&#xD;
      Aim: The aim of the study is to investigate if it is possible to reach no difference in&#xD;
      Quality of Recovery (QoR) between a high-risk patient and a low risk patient using&#xD;
      Apfel-score based PONV care.&#xD;
&#xD;
      Primary objective: Assessing Quality of Recovery, using QoR15 at 24h, 48h, 72h and after 7&#xD;
      days.&#xD;
&#xD;
      Secondary objectives: Assessing the incidence and severity of PONV and PDNV in females&#xD;
      undergoing laparoscopic surgery up to 72h. Assessing PONV and PDNV severity and duration.&#xD;
      Nicotine habits and impact on PONV.&#xD;
&#xD;
      Study outline: Females scheduled for elective abdominal laparoscopic surgery will be provided&#xD;
      PONV care based on Apfel risk-score. All patients will fill in the QoR15 form before surgery&#xD;
      (base line). PONV and PDNV will be assessed in the PACU postoperatively, after 24h, 48h and&#xD;
      72h. Quality of Recovery will be assessed up to 7 days after surgery.&#xD;
&#xD;
      Treatment: The females will be given ordinary care after local routines, with strict&#xD;
      adherence to PONV guidelines.&#xD;
&#xD;
      Study population: 100 females aged 18-65, ASA 1-2, undergoing laparoscopic abdominal surgery&#xD;
      in Danderyds Hospital.&#xD;
&#xD;
      Primary outcome variables and examinations: When the QoR 15 reaches base line or better after&#xD;
      surgery. Number of times the females experience nausea, retching or vomiting and the impact&#xD;
      of emetic symptoms on the QoR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 30, 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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>7 Days</target_duration>
  <primary_outcome>
    <measure>Quality of recovery, QoR15 (Quality of Recovery 15)</measure>
    <time_frame>7 days</time_frame>
    <description>Score, a valid questionnaire to measure quality of recovery, 15 questions, maximum score 150p. VAS scales for each items; 0 bad score, 10 optimal score. Mean values for group, sum score will be compared with parametric tests.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Quality of Recovery</condition>
  <arm_group>
    <arm_group_label>Apfel score 1</arm_group_label>
    <description>Female</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Apfel score 2</arm_group_label>
    <description>Female, non smoker</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Apfel score 3</arm_group_label>
    <description>Female, non smoker, under 40 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Apfel score 4</arm_group_label>
    <description>Female, non smoker, under 40 years old, previous history of PONV</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protocol</intervention_name>
    <description>Best practice of protocol</description>
    <arm_group_label>Apfel score 1</arm_group_label>
    <arm_group_label>Apfel score 2</arm_group_label>
    <arm_group_label>Apfel score 3</arm_group_label>
    <arm_group_label>Apfel score 4</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Female undergoing laparoscopic surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA class 1-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA 4, obese&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Danderyds Sjukhus</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>February 17, 2022</last_update_submitted>
  <last_update_submitted_qc>February 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danderyd Hospital</investigator_affiliation>
    <investigator_full_name>EmmaObrink</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Quality of recovery</keyword>
  <keyword>PONV</keyword>
  <keyword>PDNV</keyword>
  <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/NCT03820479
org study id: DanderydH
nct id: NCT03820479
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SYNOPSIS Title: An observational study to investigate Quality of Recovery and the incidence
      and impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting
      (PDNV) and up to 7 days in females undergoing laparoscopic abdominal surgery provided
      Apfel-score based PONV care and prophylaxis.

      Study period: September 2018- September 2019

      Hypothesis: When a high risk patient, Apfel-score 3 or 4, is given Apfel-score based PONV
      care with strict adherence to PONV guidelines there should be no difference in Quality of
      Recovery between a high-risk patient and a low-risk patient.

      Aim: The aim of the study is to investigate if it is possible to reach no difference in
      Quality of Recovery (QoR) between a high-risk patient and a low risk patient using
      Apfel-score based PONV care.

      Primary objective: Assessing Quality of Recovery, using QoR15 at 24h, 48h, 72h and after 7
      days.

      Secondary objectives: Assessing the incidence and severity of PONV and PDNV in females
      undergoing laparoscopic surgery up to 72h. Assessing PONV and PDNV severity and duration.
      Nicotine habits and impact on PONV.

      Study outline: Females scheduled for elective abdominal laparoscopic surgery will be provided
      PONV care based on Apfel risk-score. All patients will fill in the QoR15 form before surgery
      (base line). PONV and PDNV will be assessed in the PACU postoperatively, after 24h, 48h and
      72h. Quality of Recovery will be assessed up to 7 days after surgery.

      Treatment: The females will be given ordinary care after local routines, with strict
      adherence to PONV guidelines.

      Study population: 100 females aged 18-65, ASA 1-2, undergoing laparoscopic abdominal surgery
      in Danderyds Hospital.

      Primary outcome variables and examinations: When the QoR 15 reaches base line or better after
      surgery. Number of times the females experience nausea, retching or vomiting and the impact
      of emetic symptoms on the QoR.
observational model: Cohort
time perspective: Prospective
measure: Quality of recovery, QoR15 (Quality of Recovery 15)
time frame: 7 days
description: Score, a valid questionnaire to measure quality of recovery, 15 questions, maximum score 150p. VAS scales for each items; 0 bad score, 10 optimal score. Mean values for group, sum score will be compared with parametric tests.
arm group label: Apfel score 1
description: Female
arm group label: Apfel score 2
description: Female, non smoker
arm group label: Apfel score 3
description: Female, non smoker, under 40 years old
arm group label: Apfel score 4
description: Female, non smoker, under 40 years old, previous history of PONV
intervention type: Other
intervention name: Protocol
description: Best practice of protocol
arm group label: Apfel score 1
arm group label: Apfel score 2
arm group label: Apfel score 3
arm group label: Apfel score 4
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Danderyd Hospital
investigator full name: EmmaObrink
investigator title: Principal Investigator
sharing ipd: No