<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/NCT03825666</url>
  </required_header>
  <id_info>
    <org_study_id>Obrink2</org_study_id>
    <nct_id>NCT03825666</nct_id>
  </id_info>
  <brief_title>Can Simple Perioperative Measures Improve Quality of Recovery Following Ambulatory Laparoscopic Surgery in Females?</brief_title>
  <official_title>Can Simple Perioperative Measures Improve Quality of Recovery Following Ambulatory Laparoscopic Surgery in Females? An Open Prospective Randomised Study, Comparing Nutritional Preoperative Drink and Chewing Gum During Recovery to Standard Care.</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>
      The aim of this study was to assess whether it was possible to improve patients'&#xD;
      self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting&#xD;
      in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in&#xD;
      the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery.&#xD;
&#xD;
      Patients were randomised to an active group receiving the intervention, and controls provided&#xD;
      with standard care only. Patients were followed by questionnaire interviews preoperatively&#xD;
      and at 2, 24 and 48 hours after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abstract One major goal in modern perioperative anaesthesia care is to facilitate a rapid,&#xD;
      yet safe recovery process, with focus on improving time to regained consciousness and&#xD;
      subsequent resuming of activities of daily living. Laparoscopic cholecystectomy and&#xD;
      gynaecological laparoscopy are a &quot;high volume&quot; procedure commonly performed in young females&#xD;
      expecting rapid resumption of health.&#xD;
&#xD;
      The aim of this study was to assess whether it was possible to improve patients'&#xD;
      self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting&#xD;
      in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in&#xD;
      the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery.&#xD;
&#xD;
      Methods Patients were randomised to an active group receiving the intervention, and controls&#xD;
      provided with standard care only. Patients were followed by questionnaire interviews&#xD;
      preoperatively and at 2, 24 and 48 hours after surgery. The Quality of Recovery scale (QoR)&#xD;
      15 items and 5 additional questions around gastro-intestinal symptoms were self-assessed by&#xD;
      patients at each occasion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of recovery, QoR15, (Quality of Recovery 15)</measure>
    <time_frame>48 hours</time_frame>
    <description>Quality of recovery after laparoscopic surgery with a valid questionnaire. 15 questions, max point 150. 0 worse, 10 best score. Mean sum is going to be compared.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Quality of Recovery</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention with drink pre surgery and chewing gum post surgery. No subgroups, combined intervention will be assessed. ProvideXtra® Fresenius Kabi plus standard consumer xylitol chewing gum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group following standard guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ProvideXtra® Fresenius Kabi</intervention_name>
    <description>Improving wellbeeing</description>
    <arm_group_label>Active</arm_group_label>
    <other_name>standard consumer xylitol chewing gum</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA 3-4, obese&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</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/NCT03825666
org study id: Obrink2
nct id: NCT03825666
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to assess whether it was possible to improve patients'
      self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting
      in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in
      the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery.

      Patients were randomised to an active group receiving the intervention, and controls provided
      with standard care only. Patients were followed by questionnaire interviews preoperatively
      and at 2, 24 and 48 hours after surgery.
Abstract One major goal in modern perioperative anaesthesia care is to facilitate a rapid,
      yet safe recovery process, with focus on improving time to regained consciousness and
      subsequent resuming of activities of daily living. Laparoscopic cholecystectomy and
      gynaecological laparoscopy are a "high volume" procedure commonly performed in young females
      expecting rapid resumption of health.

      The aim of this study was to assess whether it was possible to improve patients'
      self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting
      in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in
      the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery.

      Methods Patients were randomised to an active group receiving the intervention, and controls
      provided with standard care only. Patients were followed by questionnaire interviews
      preoperatively and at 2, 24 and 48 hours after surgery. The Quality of Recovery scale (QoR)
      15 items and 5 additional questions around gastro-intestinal symptoms were self-assessed by
      patients at each occasion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Quality of recovery, QoR15, (Quality of Recovery 15)
time frame: 48 hours
description: Quality of recovery after laparoscopic surgery with a valid questionnaire. 15 questions, max point 150. 0 worse, 10 best score. Mean sum is going to be compared.
arm group label: Active
arm group type: Experimental
description: Intervention with drink pre surgery and chewing gum post surgery. No subgroups, combined intervention will be assessed. ProvideXtra® Fresenius Kabi plus standard consumer xylitol chewing gum.
arm group label: Control
arm group type: No Intervention
description: control group following standard guidelines
intervention type: Other
intervention name: ProvideXtra® Fresenius Kabi
description: Improving wellbeeing
arm group label: Active
other name: standard consumer xylitol chewing gum
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Danderyd Hospital
investigator full name: EmmaObrink
investigator title: Principal Investigator
sharing ipd: No