<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/NCT03788070</url>
  </required_header>
  <id_info>
    <org_study_id>LOLD 01-19</org_study_id>
    <nct_id>NCT03788070</nct_id>
  </id_info>
  <brief_title>Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome</brief_title>
  <acronym>DEHYD</acronym>
  <official_title>Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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 primary objective of this study is to measure the prevalence of preoperative dehydration&#xD;
      in elective major abdominal urologic surgery when we apply our daily standard operation&#xD;
      procedures. Secondary objectives are to assess the impact of preoperative dehydration on&#xD;
      postoperative outcome. The hypothesis is that preoperative dehydration leads to more&#xD;
      postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The information about the impact of preoperative dehydration on postoperative outcome is&#xD;
      conflicting. One of the reported difficulties of the studies in this field is to get adequate&#xD;
      power for statistical significance. The incidence of preoperative dehydration in different&#xD;
      surgical populations has been reported in about one third of patients. The prevalence in the&#xD;
      urologic population is not known.&#xD;
&#xD;
      This is a monocentric observational study with no study intervention. The goal is to&#xD;
      consecutively include all patients undergoing major urologic surgery during 365 days who meet&#xD;
      the inclusion criteria to assess the prevalence of preoperative dehydration in elective major&#xD;
      abdominal urologic surgery when the standard operation procedures of the University Hospital&#xD;
      Bern are applied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to COVID-19 study inclusion was halted on March 16, 2020 after 309 days.&#xD;
  </why_stopped>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 16, 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>Prevalence of Dehydration at Induction of Anesthesia</measure>
    <time_frame>Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery</time_frame>
    <description>Number of dehydrated patients judged by urine specific gravity, osmolality, creatinine, color.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Nausea and Vomiting (PONV)</measure>
    <time_frame>6 hours, 24 hours and 48 hours postoperatively</time_frame>
    <description>Number of patients with postoperative nausea and/or vomiting at 6, 24 and 48 hours postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal function (flatus/defecation) postoperatively</measure>
    <time_frame>24 hours and 48 hours postoperatively</time_frame>
    <description>Time of first flatus or defecation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function postoperatively</measure>
    <time_frame>6 hours, 24 hours and 48 hours postoperatively</time_frame>
    <description>Creatinine 6, 24 and 48 hours postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluid balance</measure>
    <time_frame>within 24 hours postoperatively</time_frame>
    <description>Judged by administered and lost fluids intraoperatively and by weight balance on postoperative day (POD) 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications within hospitalization</measure>
    <time_frame>within hospital stay, expected to be within 2 weeks postoperatively</time_frame>
    <description>Number of complications according to a prospective list</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of recovery</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Changes in Quality of Recovery using the validated 15 items quality of recovery (QoR-15) score : QoR is a patient reported outcome short questionnaire that measure the quality of recovery after surgery and anaesthesia. It incorporates 5 dimensions of health (patient support, comfort, emotions, physical independence, pain). This is a shortened validated version of the QoR 40 including 15 items. QoR-15, with a score range from 0 to 150 (0 worst possible, 150 best possible), is easy to perform. Recently a meta-analysis showed that QoR 15 fulfils requirements for outcome measurement instruments.</description>
  </secondary_outcome>
  <enrollment type="Actual">188</enrollment>
  <condition>Dehydration</condition>
  <condition>Postoperative Nausea and Vomiting</condition>
  <condition>Postoperative Complications</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The project population will be all patients undergoing major urologic surgery at the&#xD;
        Department of Urology, Inselspital Bern, meeting the inclusion criteria. The number of&#xD;
        participants depends on the amount of surgeries of patients meeting the inclusion criteria&#xD;
        taking place during the inclusion period of 365 days.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years old&#xD;
&#xD;
          -  Major elective urologic surgery i. Prostate surgery ii. Bladder surgery iii. Kidney&#xD;
             surgery iv. Various laparotomies / laparoscopies (e.g. retroperitoneal&#xD;
             lymphadenectomy)&#xD;
&#xD;
          -  Standard procedure planned&#xD;
&#xD;
          -  Standard perioperative management planned&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative iv-fluids&#xD;
&#xD;
          -  Pregnancy (which is a contraindication to this type of surgery per se)&#xD;
&#xD;
          -  Inability to give informed consent (e.g. severe psychiatric disorder, dementia)&#xD;
&#xD;
          -  Inability to complete the Quality of Recovery (QoR) questionnaire&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#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>Lukas M Löffel, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inselspital University Hospital Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inselspital University Hospital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>May 15, 2020</last_update_submitted>
  <last_update_submitted_qc>May 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dehydration</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <!-- 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/NCT03788070
org study id: LOLD 01-19
nct id: NCT03788070
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to measure the prevalence of preoperative dehydration
      in elective major abdominal urologic surgery when we apply our daily standard operation
      procedures. Secondary objectives are to assess the impact of preoperative dehydration on
      postoperative outcome. The hypothesis is that preoperative dehydration leads to more
      postoperative complications.
The information about the impact of preoperative dehydration on postoperative outcome is
      conflicting. One of the reported difficulties of the studies in this field is to get adequate
      power for statistical significance. The incidence of preoperative dehydration in different
      surgical populations has been reported in about one third of patients. The prevalence in the
      urologic population is not known.

      This is a monocentric observational study with no study intervention. The goal is to
      consecutively include all patients undergoing major urologic surgery during 365 days who meet
      the inclusion criteria to assess the prevalence of preoperative dehydration in elective major
      abdominal urologic surgery when the standard operation procedures of the University Hospital
      Bern are applied.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of Dehydration at Induction of Anesthesia
time frame: Time point 0: time (estimated between 7am and 4pm on day of surgery) at Induction of Anesthesia for Major Urologic Surgery
description: Number of dehydrated patients judged by urine specific gravity, osmolality, creatinine, color.
measure: Postoperative Nausea and Vomiting (PONV)
time frame: 6 hours, 24 hours and 48 hours postoperatively
description: Number of patients with postoperative nausea and/or vomiting at 6, 24 and 48 hours postoperatively.
measure: Gastrointestinal function (flatus/defecation) postoperatively
time frame: 24 hours and 48 hours postoperatively
description: Time of first flatus or defecation
measure: Renal function postoperatively
time frame: 6 hours, 24 hours and 48 hours postoperatively
description: Creatinine 6, 24 and 48 hours postoperatively.
measure: Fluid balance
time frame: within 24 hours postoperatively
description: Judged by administered and lost fluids intraoperatively and by weight balance on postoperative day (POD) 1.
measure: Complications within hospitalization
time frame: within hospital stay, expected to be within 2 weeks postoperatively
description: Number of complications according to a prospective list
measure: Quality of recovery
time frame: 24 hours postoperatively
description: Changes in Quality of Recovery using the validated 15 items quality of recovery (QoR-15) score : QoR is a patient reported outcome short questionnaire that measure the quality of recovery after surgery and anaesthesia. It incorporates 5 dimensions of health (patient support, comfort, emotions, physical independence, pain). This is a shortened validated version of the QoR 40 including 15 items. QoR-15, with a score range from 0 to 150 (0 worst possible, 150 best possible), is easy to perform. Recently a meta-analysis showed that QoR 15 fulfils requirements for outcome measurement instruments.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lukas M Löffel, M.D.
role: Principal Investigator
affiliation: Inselspital University Hospital Bern
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Dehydration
mesh term: Vomiting
mesh term: Postoperative Complications
mesh term: Postoperative Nausea and Vomiting