<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/NCT03757208</url>
  </required_header>
  <id_info>
    <org_study_id>Uoulu 192/2012</org_study_id>
    <nct_id>NCT03757208</nct_id>
  </id_info>
  <brief_title>Preoperative Carbohydrate Loading in Patients Undergoing Day-case Cholecystectomy</brief_title>
  <official_title>Effect of Preoperative Oral Carbohydrate Loading on Recovery in Patients Undergoing Day-case Cholecystectomy. A Randomised Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oulu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seinajoki Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oulu</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Preoperative carbohydrate loading has been shown to reduce preoperative&#xD;
      discomfort and postoperative nausea and vomiting in general surgical patients. Few studies&#xD;
      have been focused on patients undergoing day-case surgery.&#xD;
&#xD;
      Objective: The aim of this prospective randomized study was to determine whether preoperative&#xD;
      carbohydrate loading enhanced the recovery of patients undergoing day-case cholecystectomy.&#xD;
&#xD;
      Design: A randomised controlled trial. Setting: Secondary care in a district general and a&#xD;
      university hospital in Finland between 2013-2016.&#xD;
&#xD;
      Patients: A total of 113 patients ASA physical status I or II (18-70 yr) undergoing day-case&#xD;
      cholecystectomy were included in the study. Exclusion criteria were bleeding or coagulation&#xD;
      disorders, BMI &gt;40, dementia, insulin-treated diabetes, migraine, Meniere's disease or a&#xD;
      history of alcohol or drug abuse.&#xD;
&#xD;
      Intervention: The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3&#xD;
      h before surgery, and the control (Fasting) group fasted from midnight according to standard&#xD;
      protocol.&#xD;
&#xD;
      Main outcome measures: Visual analogue scales (VAS) were used to score six discomfort&#xD;
      parameters. The needs for analgesia or antiemetics, the time to drinking, eating and first&#xD;
      mobilization after surgery, and the time to discharge and hospital readmission were recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 8, 2013</start_date>
  <completion_date type="Actual">November 15, 2017</completion_date>
  <primary_completion_date type="Actual">May 16, 2016</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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of given pain and antiemetic medication (n)</measure>
    <time_frame>One day (in recovery room after operation to discharge time)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Thirst, hunger, dryness of mouth, tiredness, nausea, and pain (Visual analogue scale, VAS 0-100)</measure>
    <time_frame>One day (4 hours after operation and at discharge)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of drinking, eating and first mobilisation (minutes after operation)</measure>
    <time_frame>One day (in recovery room after operation to discharge time)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of discharge (hours after operation)</measure>
    <time_frame>One day (time of discharge)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Preoperative Care</condition>
  <arm_group>
    <arm_group_label>Fasting group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbohydrate rich drink (CHD) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>carbohydrate rich drink</intervention_name>
    <description>The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery,</description>
    <arm_group_label>Carbohydrate rich drink (CHD) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 18-70 yr (ASA physical status I-II) eligible for day-case&#xD;
             cholecystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with bleeding or coagulation disorders, BMI &gt;40, dementia or suffering from&#xD;
             insulin-treated diabetes, migraine, Meniere's disease or with history of alcohol or&#xD;
             drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kari Haukipuro, Ph.M.D</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital of Oulu</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oulu</investigator_affiliation>
    <investigator_full_name>Heli Helminen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Carbohydrate loading, oral carbohydrate beverage</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/NCT03757208
org study id: Uoulu 192/2012
nct id: NCT03757208
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Background: Preoperative carbohydrate loading has been shown to reduce preoperative
      discomfort and postoperative nausea and vomiting in general surgical patients. Few studies
      have been focused on patients undergoing day-case surgery.

      Objective: The aim of this prospective randomized study was to determine whether preoperative
      carbohydrate loading enhanced the recovery of patients undergoing day-case cholecystectomy.

      Design: A randomised controlled trial. Setting: Secondary care in a district general and a
      university hospital in Finland between 2013-2016.

      Patients: A total of 113 patients ASA physical status I or II (18-70 yr) undergoing day-case
      cholecystectomy were included in the study. Exclusion criteria were bleeding or coagulation
      disorders, BMI >40, dementia, insulin-treated diabetes, migraine, Meniere's disease or a
      history of alcohol or drug abuse.

      Intervention: The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3
      h before surgery, and the control (Fasting) group fasted from midnight according to standard
      protocol.

      Main outcome measures: Visual analogue scales (VAS) were used to score six discomfort
      parameters. The needs for analgesia or antiemetics, the time to drinking, eating and first
      mobilization after surgery, and the time to discharge and hospital readmission were recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Number of given pain and antiemetic medication (n)
time frame: One day (in recovery room after operation to discharge time)
measure: Thirst, hunger, dryness of mouth, tiredness, nausea, and pain (Visual analogue scale, VAS 0-100)
time frame: One day (4 hours after operation and at discharge)
measure: Time of drinking, eating and first mobilisation (minutes after operation)
time frame: One day (in recovery room after operation to discharge time)
measure: Time of discharge (hours after operation)
time frame: One day (time of discharge)
arm group label: Fasting group
arm group type: No Intervention
arm group label: Carbohydrate rich drink (CHD) group
arm group type: Active Comparator
intervention type: Dietary Supplement
intervention name: carbohydrate rich drink
description: The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery,
arm group label: Carbohydrate rich drink (CHD) group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kari Haukipuro, Ph.M.D
role: Study Chair
affiliation: University Hospital of Oulu
responsible party type: Principal Investigator
investigator affiliation: University of Oulu
investigator full name: Heli Helminen
investigator title: Principal Investigator
sharing ipd: No