xml: <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/NCT06008496</url>
    </required_header>
    <id_info>
      <org_study_id>23/SED/793</org_study_id>
      <nct_id>NCT06008496</nct_id>
    </id_info>
    <brief_title>Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery (POPPY)</brief_title>
    <acronym>POPPY</acronym>
    <official_title>The POPPY Study: Patient Reported Outcomes, Postoperative Pain and Pain Relief After Day Case Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Plymouth NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute for Academic Anaesthesia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Newcastle PROMS</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Research and Audit Federation of Anaesthetic Trainees (RAFT)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Plymouth</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital Plymouth NHS Trust</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Around 3 out of 4 operations in the UK are performed as day-case, meaning the patient goes&#xD;
        home on the same day of their operation. Hospitals usually do not follow up patients after&#xD;
        day-case operations so we do not know very much about their short or long-term recovery. Some&#xD;
        patients, even those who have had small operations, can develop persistent pain afterwards&#xD;
        that continues for a long time (months to years). These patients may end up taking strong&#xD;
        painkillers for a long time and this risks serious side effects and long-term health&#xD;
        problems.&#xD;
  &#xD;
        The POPPY study aims to find out what recovery from day-case operations is like from the&#xD;
        patient's point of view. We will look at the first week after patients' operations and then&#xD;
        at 3 months to see if they are in pain, and if so what pain relief they are taking.&#xD;
  &#xD;
        All adults over the 5-day study period having day-case operations in the UK, with an&#xD;
        anaesthetist, will be eligible if they have access to a smartphone. Patients will be&#xD;
        recruited on the day of their operation from over 100 NHS hospitals. Some relevant&#xD;
        information about the patient's current health, operation and anaesthetic will be recorded&#xD;
        from their notes. Afterwards participants will get a text message at days 1, 3 and 7 and the&#xD;
        at 3 months. These will connect to a data secure online questionnaire about pain, recovery,&#xD;
        and what medications they are taking. A small number of participants with ongoing pain at 3&#xD;
        months will be invited to take part in a structured interview to understand their experience&#xD;
        in more depth.&#xD;
  &#xD;
        This study will provide important information that may be used to improve care of patients&#xD;
        having day-case operations and plan future research studies aimed to prevent persistent pain&#xD;
        and long-term use of strong painkillers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>To measure short and long-term patient reported outcomes in UK day-case surgery patients.</measure>
      <time_frame>3 months</time_frame>
      <description>See below outcomes for specifics (this is an overarching outcome which is broken down in the outcomes described below).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short-term: to describe the quality of recovery over the first postoperative week</measure>
      <time_frame>1 week</time_frame>
      <description>QOR-15 score (quality of recovery-15 score); BPI (brief pain inventory) derived pain scores; FPS (functional pain score)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Long-term: to establish the prevalence of persistent postsurgical pain (PPSP) and persistent postoperative opioid use (PPOU) in day case surgical patients.</measure>
      <time_frame>3 months</time_frame>
      <description>PPOU prevalence (from medication use); pain at surgical site questionnaire; GAD-7 Score (generalised anxiety and depression 7 score); EQ-5D-5L score; BPI score; PHQ-8 Score (Patient Health Questionnaire 8)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To identify those patient, medication, anaesthetic, and surgical characteristics that are associated with poor quality of recovery, and PPSP and/or PPOU</measure>
      <time_frame>3 months</time_frame>
      <description>Baseline data collection: age, sex, operation type, anaesthetic type, baseline medications and medication use on day 1, 3, 7 and 97 post-op. Medication use recorded as frequency of use and medication type.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To describe the acute pain experience and analgesia use in the first postoperative week</measure>
      <time_frame>1 week</time_frame>
      <description>BPI (brief pain inventory) score on days 1, 3, 7; analgesia medication use on days 1, 3, 7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To estimate the need for further healthcare support in the first postoperative week</measure>
      <time_frame>1 week</time_frame>
      <description>Yes/no question on questionnaire on day 7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To determine the patient reported acceptability of SMS prompted follow-up</measure>
      <time_frame>1 week</time_frame>
      <description>Acceptability question on questionnaire on day 7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To determine the difference in quality of life between participants with and without PPSP</measure>
      <time_frame>3 months</time_frame>
      <description>PHQ-8 Score; GAD-7 Score; EQ-5D-5L score at day 97</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To investigate the difficulty in reducing opioid use in participants with PPOU</measure>
      <time_frame>3 months</time_frame>
      <description>Yes/no question on questionnaire at day 97</description>
    </secondary_outcome>
    <other_outcome>
      <measure>To explore patient experience of; Preparation for day case surgery and pre-operative expectations Acute recovery (first postoperative week) Longer-term recovery and post-operative pain (after 3 months) Opioids: intake, type, duration and experience.</measure>
      <time_frame>4-5 months</time_frame>
      <description>Semi-structured questionnaires after day 97, regarding the topics listed above</description>
    </other_outcome>
    <enrollment type="Anticipated">6000</enrollment>
    <condition>Pain</condition>
    <condition>Post Operative Pain</condition>
    <condition>Opioid Use</condition>
    <condition>Chronic Pain</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Day case surgery</intervention_name>
      <description>Operation, surgical group, magnitude of surgery, anaesthetic type.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults undergoing day-case surgery in the UK&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18 years or older on day of surgery&#xD;
  &#xD;
            -  Day-case surgery as defined by National Day Surgery Delivery Pack (NEED REF)&#xD;
  &#xD;
            -  An anaesthetist must be present for case.&#xD;
  &#xD;
            -  The procedure must involve one or more of: sedation, regional anaesthesia, central&#xD;
               neuraxial anaesthesia or general anaesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Less than 18 years of age on day of surgery&#xD;
  &#xD;
            -  No anaesthetist involved with the procedure (such as local anaesthesia provided by a&#xD;
               surgeon)&#xD;
  &#xD;
            -  Overnight stay (admission to hospital)&#xD;
  &#xD;
            -  Participant lacking capacity for consent&#xD;
  &#xD;
            -  Diagnostic and/or minimally invasive procedures (e.g., radiology, endoscopy, or&#xD;
               cardiology procedures)&#xD;
  &#xD;
            -  Pregnancy or obstetric related procedures (pregnancy per-se is not an exclusion&#xD;
               criterion).&#xD;
  &#xD;
            -  Currently breast feeding&#xD;
  &#xD;
            -  Ophthalmic procedures&#xD;
  &#xD;
            -  No access to Smartphone and email&#xD;
  &#xD;
            -  Prisoners&#xD;
  &#xD;
          Eligibility for qualitative component:&#xD;
  &#xD;
          As above, plus reporting PPSP and/or PPOU at day 97 post operative&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>110 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mark Rockett, MBBS, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University Hospitals Plymouth NHS Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Matthew Everson, MBBS, FRCA</last_name>
      <phone>07749410572</phone>
      <email>matthew.everson@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Victoria Yates, BSc (Hons)</last_name>
      <phone>01752 439992</phone>
      <email>victoriayates@nhs.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospitals Plymouth NHS Trust</name>
        <address>
          <city>Plymouth</city>
          <state>Devon</state>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Victoria Carrington Yates</last_name>
        <phone>01752 439992</phone>
        <email>victoriayates@nhs.net</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <link>
      <url>https://www.raftrainees.org/raft-4-poppy</url>
      <description>Study website with latest study documents.</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</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>Pain, Postoperative</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008496
  org study id: 23/SED/793
  nct id: NCT06008496
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Around 3 out of 4 operations in the UK are performed as day-case, meaning the patient goes
        home on the same day of their operation. Hospitals usually do not follow up patients after
        day-case operations so we do not know very much about their short or long-term recovery. Some
        patients, even those who have had small operations, can develop persistent pain afterwards
        that continues for a long time (months to years). These patients may end up taking strong
        painkillers for a long time and this risks serious side effects and long-term health
        problems.
  
        The POPPY study aims to find out what recovery from day-case operations is like from the
        patient's point of view. We will look at the first week after patients' operations and then
        at 3 months to see if they are in pain, and if so what pain relief they are taking.
  
        All adults over the 5-day study period having day-case operations in the UK, with an
        anaesthetist, will be eligible if they have access to a smartphone. Patients will be
        recruited on the day of their operation from over 100 NHS hospitals. Some relevant
        information about the patient's current health, operation and anaesthetic will be recorded
        from their notes. Afterwards participants will get a text message at days 1, 3 and 7 and the
        at 3 months. These will connect to a data secure online questionnaire about pain, recovery,
        and what medications they are taking. A small number of participants with ongoing pain at 3
        months will be invited to take part in a structured interview to understand their experience
        in more depth.
  
        This study will provide important information that may be used to improve care of patients
        having day-case operations and plan future research studies aimed to prevent persistent pain
        and long-term use of strong painkillers.
  observational model: Cohort
  time perspective: Prospective
  measure: To measure short and long-term patient reported outcomes in UK day-case surgery patients.
  time frame: 3 months
  description: See below outcomes for specifics (this is an overarching outcome which is broken down in the outcomes described below).
  measure: Short-term: to describe the quality of recovery over the first postoperative week
  time frame: 1 week
  description: QOR-15 score (quality of recovery-15 score); BPI (brief pain inventory) derived pain scores; FPS (functional pain score)
  measure: Long-term: to establish the prevalence of persistent postsurgical pain (PPSP) and persistent postoperative opioid use (PPOU) in day case surgical patients.
  time frame: 3 months
  description: PPOU prevalence (from medication use); pain at surgical site questionnaire; GAD-7 Score (generalised anxiety and depression 7 score); EQ-5D-5L score; BPI score; PHQ-8 Score (Patient Health Questionnaire 8)
  measure: To identify those patient, medication, anaesthetic, and surgical characteristics that are associated with poor quality of recovery, and PPSP and/or PPOU
  time frame: 3 months
  description: Baseline data collection: age, sex, operation type, anaesthetic type, baseline medications and medication use on day 1, 3, 7 and 97 post-op. Medication use recorded as frequency of use and medication type.
  measure: To describe the acute pain experience and analgesia use in the first postoperative week
  time frame: 1 week
  description: BPI (brief pain inventory) score on days 1, 3, 7; analgesia medication use on days 1, 3, 7
  measure: To estimate the need for further healthcare support in the first postoperative week
  time frame: 1 week
  description: Yes/no question on questionnaire on day 7
  measure: To determine the patient reported acceptability of SMS prompted follow-up
  time frame: 1 week
  description: Acceptability question on questionnaire on day 7
  measure: To determine the difference in quality of life between participants with and without PPSP
  time frame: 3 months
  description: PHQ-8 Score; GAD-7 Score; EQ-5D-5L score at day 97
  measure: To investigate the difficulty in reducing opioid use in participants with PPOU
  time frame: 3 months
  description: Yes/no question on questionnaire at day 97
  measure: To explore patient experience of; Preparation for day case surgery and pre-operative expectations Acute recovery (first postoperative week) Longer-term recovery and post-operative pain (after 3 months) Opioids: intake, type, duration and experience.
  time frame: 4-5 months
  description: Semi-structured questionnaires after day 97, regarding the topics listed above
  intervention type: Procedure
  intervention name: Day case surgery
  description: Operation, surgical group, magnitude of surgery, anaesthetic type.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 110 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mark Rockett, MBBS, PhD
  role: Study Director
  affiliation: University Hospitals Plymouth NHS Trust
  last name: Matthew Everson, MBBS, FRCA
  phone: 07749410572
  email: matthew.everson@nhs.net
  last name: Victoria Yates, BSc (Hons)
  phone: 01752 439992
  email: victoriayates@nhs.net
  facility: 
  contact: 
  country: United Kingdom
  url: https://www.raftrainees.org/raft-4-poppy
  description: Study website with latest study documents.
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  mesh term: Chronic Pain
  sharing ipd: Undecided