<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/NCT03032822</url>
  </required_header>
  <id_info>
    <org_study_id>2017H0430</org_study_id>
    <nct_id>NCT03032822</nct_id>
  </id_info>
  <brief_title>Opioid Consumption in Cystectomy Patients</brief_title>
  <official_title>Opioid Consumption After Hospital Discharge in Cystectomy Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At the Ohio State University, and across the country, surgical patients admitted to the&#xD;
      hospital are over-prescribed a significant amount of opioid medications upon discharge to&#xD;
      home. Recent studies reveal that a large percentage of patients prescribed opioid medications&#xD;
      after surgery have approximately half of the prescribed medication left over. This study aims&#xD;
      to evaluate reported opioid use after surgery in patients undergoing cystectomy in order to&#xD;
      better approach the issue with current opioid use and abuse trends while still providing&#xD;
      adequate medical care and pain management to patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies show that 67% of patients prescribed opioid medications in urologic&#xD;
      procedures and surgeries had leftover opioid medications with a mean use of about half the&#xD;
      medications prescribed. A similar study in thoracic surgery patients reported similar results&#xD;
      with 71% of patients admitting to taking half or less of their prescribed opioid medications.&#xD;
      Recent advancements in cystectomy protocol have already shown promise with reducing hospital&#xD;
      length of stay from eight to four days, including the simultaneous reduction of opioid&#xD;
      analgesics for pain management, with 4.9 mg morphine equivalents per day when using enhanced&#xD;
      recovery techniques compared to 20.67 mg in traditional care. Results of the current&#xD;
      prospective study could further support these results and include low to no risk assessments&#xD;
      and follow-up phone calls. This study is observational and involves consenting adult patients&#xD;
      undergoing cystectomy to pre-operative assessments including the Self Administered&#xD;
      Gerocognitive Exam (SAGE) questionnaire, a cognitive test to identify mild-moderate cognitive&#xD;
      impairment, and collection of demographic data and medical history. Phone call follow-ups&#xD;
      include assessments of post-discharge pain and opioid consumption, and completing verbally an&#xD;
      adapted Activities of Daily Living questionnaire. No additional risks have been identified by&#xD;
      participating in this study. Participants may not directly benefit from participating in this&#xD;
      trial, but the data collected could provide valuable insight into the discrepancy between&#xD;
      required opioid pain medications and opioid pain medication prescription for adequate pain&#xD;
      management. This insight could then be applied to reevaluate post-discharge pain management&#xD;
      procedures and standards of care, therefore curbing opioid use and abuse trends&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 17, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>opioid consumption over time</measure>
    <time_frame>once per week, up to six weeks after surgery</time_frame>
    <description>The opioid medication (oral morphine equivalent) taken by the patients will be assessed every week until the sixth postoperative week, to compare it with the amount prescribed by the physicians</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Cystostomy; Complications</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>All Patients</arm_group_label>
    <description>All cystectomy patients who consent for the study</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients at the OSUMC, 18 years of age and older scheduled to undergo a cystecotomy,&#xD;
        who give written informed consent to participate in the study and who meet all inclusion&#xD;
        and no exclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing cystectomy&#xD;
&#xD;
          -  Capable and willing to consent&#xD;
&#xD;
          -  Participants literate in English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of drug and/or alcohol abuse/dependency&#xD;
&#xD;
          -  Ketamine use during hospitalization&#xD;
&#xD;
          -  Illiteracy&#xD;
&#xD;
          -  Presence of a clinically diagnosed major psychiatric condition such as bipolar&#xD;
             disorder, uncontrolled major depression, schizophrenia&#xD;
&#xD;
          -  Any condition that the principle investigator may disqualify the patient&#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>Tristan E Weaver, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>January Kim</last_name>
    <phone>614-293-3559</phone>
    <email>january.kim@osumc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nicoleta Stoicea, MD, PhD</last_name>
    <phone>614-293-0775</phone>
    <email>Nicoleta.Stoicea@osumc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicoleta Stoicea, MD, PhD</last_name>
      <phone>614-293-0775</phone>
      <email>Nicoleta.Stoicea@osumc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Angela Sipes, BS, BA</last_name>
      <phone>614-293-3559</phone>
      <email>Angela.Sipes@osumc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Tristan Weaver</investigator_full_name>
    <investigator_title>Assistant Professor - Clinical</investigator_title>
  </responsible_party>
  <keyword>Opioid consumption</keyword>
  <keyword>postdischarge</keyword>
  <keyword>cystectomy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Efforts will be made to keep patient information confidential. individual participant data will only be available to researchers who are approved by the Institutional Review Board (IRB) to participate in study enrollment, follow up and data analysis.</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/NCT03032822
org study id: 2017H0430
nct id: NCT03032822
lead sponsor: 
has dmc: No
At the Ohio State University, and across the country, surgical patients admitted to the
      hospital are over-prescribed a significant amount of opioid medications upon discharge to
      home. Recent studies reveal that a large percentage of patients prescribed opioid medications
      after surgery have approximately half of the prescribed medication left over. This study aims
      to evaluate reported opioid use after surgery in patients undergoing cystectomy in order to
      better approach the issue with current opioid use and abuse trends while still providing
      adequate medical care and pain management to patients.
Previous studies show that 67% of patients prescribed opioid medications in urologic
      procedures and surgeries had leftover opioid medications with a mean use of about half the
      medications prescribed. A similar study in thoracic surgery patients reported similar results
      with 71% of patients admitting to taking half or less of their prescribed opioid medications.
      Recent advancements in cystectomy protocol have already shown promise with reducing hospital
      length of stay from eight to four days, including the simultaneous reduction of opioid
      analgesics for pain management, with 4.9 mg morphine equivalents per day when using enhanced
      recovery techniques compared to 20.67 mg in traditional care. Results of the current
      prospective study could further support these results and include low to no risk assessments
      and follow-up phone calls. This study is observational and involves consenting adult patients
      undergoing cystectomy to pre-operative assessments including the Self Administered
      Gerocognitive Exam (SAGE) questionnaire, a cognitive test to identify mild-moderate cognitive
      impairment, and collection of demographic data and medical history. Phone call follow-ups
      include assessments of post-discharge pain and opioid consumption, and completing verbally an
      adapted Activities of Daily Living questionnaire. No additional risks have been identified by
      participating in this study. Participants may not directly benefit from participating in this
      trial, but the data collected could provide valuable insight into the discrepancy between
      required opioid pain medications and opioid pain medication prescription for adequate pain
      management. This insight could then be applied to reevaluate post-discharge pain management
      procedures and standards of care, therefore curbing opioid use and abuse trends
observational model: Cohort
time perspective: Prospective
measure: opioid consumption over time
time frame: once per week, up to six weeks after surgery
description: The opioid medication (oral morphine equivalent) taken by the patients will be assessed every week until the sixth postoperative week, to compare it with the amount prescribed by the physicians
arm group label: All Patients
description: All cystectomy patients who consent for the study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tristan E Weaver, MD
role: Principal Investigator
affiliation: Ohio State University
last name: January Kim
phone: 614-293-3559
email: january.kim@osumc.edu
last name: Nicoleta Stoicea, MD, PhD
phone: 614-293-0775
email: Nicoleta.Stoicea@osumc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Tristan Weaver
investigator title: Assistant Professor - Clinical
sharing ipd: No
ipd description: Efforts will be made to keep patient information confidential. individual participant data will only be available to researchers who are approved by the Institutional Review Board (IRB) to participate in study enrollment, follow up and data analysis.