<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/NCT04486079</url>
  </required_header>
  <id_info>
    <org_study_id>PreOpxBariatric</org_study_id>
    <nct_id>NCT04486079</nct_id>
  </id_info>
  <brief_title>Preoperative Carbohydrate Loading in Bariatric Surgery</brief_title>
  <official_title>Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Gdansk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Gdansk</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>
      The aim of this study is to perform a randomized non-blinded clinical trial to assess&#xD;
      influence of preoperative carbohydrates loading in patients undergoing bariatric surgery&#xD;
      measured by changes in the course of the postoperative period, changes in body composition&#xD;
      and changes in insulin resistance&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 20, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 20, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QoR40 score</measure>
    <time_frame>1st postoperatie day</time_frame>
    <description>Quality of recovery after surgery will be assessed by the QoR40 survey Full scale title: Quality of Recovery 40-item questionnaires range from 40 (extremely poor. quality of recovery) to 200 (excellent quality of recovery)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HOMA-IR</measure>
    <time_frame>first assay one month before the operation, the second assay on the first postoperative day</time_frame>
    <description>changes in insulin resistance will be assessed with HOMA index (Homeostatic Model Assessment for Insulin Resistance)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>first assay one month before the operation, the second assay on the first postoperative day</time_frame>
    <description>changes in body composition will be assessed by electric bioimpedance method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days</time_frame>
    <description>length of stay record in hours</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>Carbohyrate loading</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fasting</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutricia PreOp</intervention_name>
    <description>A clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink for preoperative surgical patients. Used in studies supporting the Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines.</description>
    <arm_group_label>Carbohyrate loading</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obtaining written and informed patient consent.&#xD;
&#xD;
          -  No medical contraindications to perform a bariatric operation&#xD;
&#xD;
          -  No contraindications for the use of a rich carbohydrate drink&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No consent to participate in the study&#xD;
&#xD;
          -  Age under 18 years&#xD;
&#xD;
          -  The intolerance of the carbohydrate drink used in the test&#xD;
&#xD;
          -  The contraindications to perform bioimpedance measurements of body composition&#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>Maciej Wilczyński</last_name>
    <role>Principal Investigator</role>
    <affiliation>General Surgery Resident, PhD Fellow, Teaching Assistant</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maciej Wilczyński</last_name>
    <phone>603383368</phone>
    <email>mwilczynski@gumed.edu.pl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of General, Endocrine and Transplant Surgery Medical University of Gdańsk</name>
      <address>
        <city>Gdańsk</city>
        <state>Pomerania</state>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maciej Wilczyński, doctor</last_name>
      <phone>603383368</phone>
      <phone_ext>+48</phone_ext>
      <email>mwilczynski@gumed.edu.pl</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <results_reference>
    <citation>Knight P, Chou J, Dusseljee M, Verseman S, Elian A. Effective reduction in stress induced postoperative hyperglycemia in bariatric surgery by better carb loading. Am J Surg. 2020 Mar;219(3):396-398. doi: 10.1016/j.amjsurg.2019.10.042. Epub 2019 Nov 9.</citation>
    <PMID>31757437</PMID>
  </results_reference>
  <results_reference>
    <citation>Grant MC, Gibbons MM, Ko CY, Wick EC, Cannesson M, Scott MJ, McEvoy MD, King AB, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Bariatric Surgery. Anesth Analg. 2019 Jul;129(1):51-60. doi: 10.1213/ANE.0000000000003696.</citation>
    <PMID>30113392</PMID>
  </results_reference>
  <results_reference>
    <citation>Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21.</citation>
    <PMID>28000931</PMID>
  </results_reference>
  <results_reference>
    <citation>Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, Vignaud M, Alvarez A, Singh PM, Lobo DN. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. World J Surg. 2016 Sep;40(9):2065-83. doi: 10.1007/s00268-016-3492-3.</citation>
    <PMID>26943657</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bariatric surgery</keyword>
  <keyword>carbohydrate loading</keyword>
  <keyword>insulin resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Medical University of Gdańsk will be the owner of 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/NCT04486079
org study id: PreOpxBariatric
nct id: NCT04486079
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to perform a randomized non-blinded clinical trial to assess
      influence of preoperative carbohydrates loading in patients undergoing bariatric surgery
      measured by changes in the course of the postoperative period, changes in body composition
      and changes in insulin resistance
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: QoR40 score
time frame: 1st postoperatie day
description: Quality of recovery after surgery will be assessed by the QoR40 survey Full scale title: Quality of Recovery 40-item questionnaires range from 40 (extremely poor. quality of recovery) to 200 (excellent quality of recovery)
measure: HOMA-IR
time frame: first assay one month before the operation, the second assay on the first postoperative day
description: changes in insulin resistance will be assessed with HOMA index (Homeostatic Model Assessment for Insulin Resistance)
measure: Body composition
time frame: first assay one month before the operation, the second assay on the first postoperative day
description: changes in body composition will be assessed by electric bioimpedance method
measure: Length of hospital stay
time frame: From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days
description: length of stay record in hours
arm group label: Carbohyrate loading
arm group type: Experimental
description: Group A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group.
arm group label: Fasting
arm group type: No Intervention
description: Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard.
intervention type: Dietary Supplement
intervention name: Nutricia PreOp
description: A clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink for preoperative surgical patients. Used in studies supporting the Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines.
arm group label: Carbohyrate loading
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maciej Wilczyński
role: Principal Investigator
affiliation: General Surgery Resident, PhD Fellow, Teaching Assistant
last name: Maciej Wilczyński
phone: 603383368
email: mwilczynski@gumed.edu.pl
facility: 
status: Recruiting
contact: 
country: Poland
citation: Knight P, Chou J, Dusseljee M, Verseman S, Elian A. Effective reduction in stress induced postoperative hyperglycemia in bariatric surgery by better carb loading. Am J Surg. 2020 Mar;219(3):396-398. doi: 10.1016/j.amjsurg.2019.10.042. Epub 2019 Nov 9.
PMID: 31757437
citation: Grant MC, Gibbons MM, Ko CY, Wick EC, Cannesson M, Scott MJ, McEvoy MD, King AB, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Bariatric Surgery. Anesth Analg. 2019 Jul;129(1):51-60. doi: 10.1213/ANE.0000000000003696.
PMID: 30113392
citation: Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21.
PMID: 28000931
citation: Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, Vignaud M, Alvarez A, Singh PM, Lobo DN. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. World J Surg. 2016 Sep;40(9):2065-83. doi: 10.1007/s00268-016-3492-3.
PMID: 26943657
responsible party type: Sponsor
mesh term: Obesity, Morbid
sharing ipd: No
ipd description: Medical University of Gdańsk will be the owner of data