<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/NCT03772392</url>
  </required_header>
  <id_info>
    <org_study_id>18185</org_study_id>
    <nct_id>NCT03772392</nct_id>
  </id_info>
  <brief_title>Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic Surgery</brief_title>
  <official_title>Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Lothian</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</source>
  <oversight_info>
    <has_dmc>No</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>
      ERAS protocols have been utilized extensively in abdominal and non abdominal surgery over the&#xD;
      past 20 years. These protocols incorporate evidence based, multi-disciplinary peri-operative&#xD;
      care components. Compliance with these protocols is associated with reduced length of stay,&#xD;
      reduced morbidity and reduced hospital costs.&#xD;
&#xD;
      ERAS protocols within HPB units are les well established with less evidence supporting their&#xD;
      use. Liver resection protocols are increasing in use, but ERAS post Whipples resection is&#xD;
      less established.&#xD;
&#xD;
      In the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a&#xD;
      recent audit identified that that the compliance rate is low with compliance rates as low as&#xD;
      30 per cent in some care domains.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1.1 Background&#xD;
&#xD;
      Enhanced Recovery After Surgery(ERAS) protocols have been utilized extensively in abdominal&#xD;
      and non abdominal surgery over the past 20 years. These protocols incorporate evidence based,&#xD;
      multi-disciplinary peri-operative care components. Compliance with these protocols is&#xD;
      associated with reduced length of stay, reduced morbidity and reduced hospital costs.&#xD;
&#xD;
      ERAS protocols within hepatobiliary pancreatic (HPB) units are les well established with less&#xD;
      evidence supporting their use. Liver resection protocols are increasing in use, but ERAS post&#xD;
      Whipples resection is less established.&#xD;
&#xD;
      1.2 RATIONALE FOR STUDY&#xD;
&#xD;
      In the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a&#xD;
      recent audit identified that that the compliance rate is low with compliance rates as low as&#xD;
      30 per cent in some care domains.&#xD;
&#xD;
      2. OBJECTIVES&#xD;
&#xD;
      To compare the compliance of ERAS protocol care components within an HPB unit before and&#xD;
      after an education programme.&#xD;
&#xD;
      3. STUDY POPULATION&#xD;
&#xD;
      3.1 NUMBER OF PARTICIPANTS An attempt to observe 100 patients will be made over the study&#xD;
      period. A preliminary audit of 27 patients has been performed.&#xD;
&#xD;
      4. PARICIPANT SELECTION&#xD;
&#xD;
      4.1 IDENTIFYING PARTICIPANTS&#xD;
&#xD;
      Those patients to be included will be identified from the theatre schedule as listed for HPB&#xD;
      resectional surgery. Their compliance with the ERAS protocol will then be observed over the&#xD;
      course of their stay.&#xD;
&#xD;
      4.2 CONSENT The ERAS protocol is part of the unit policy and so patients will not be&#xD;
      undergoing any intervention that is not already part of normal practice and consent.&#xD;
      Therefore further or additional consent will not be required.&#xD;
&#xD;
      5. DATA COLLECTION Over a six month period the compliance to the ERAS protocol will be&#xD;
      assessed in patients undergoing HPB resections.&#xD;
&#xD;
      Compliance programme&#xD;
&#xD;
        1. Patients will be given an information leaflet describing their post-operative care&#xD;
           pathway&#xD;
&#xD;
        2. Nursing and medical staff will receive education regarding the ERAS protocol and&#xD;
           achievements&#xD;
&#xD;
        3. Auditing of the ERAS protocol adherence will subsequently be performed&#xD;
&#xD;
      Outcome measures&#xD;
&#xD;
        1. Functional recovery&#xD;
&#xD;
        2. Morbidity&#xD;
&#xD;
        3. Compliance rate of the individual peri-operative care components&#xD;
&#xD;
        4. Drop out rate&#xD;
&#xD;
        5. Length of stay&#xD;
&#xD;
        6. STATISTICAL ANALYSIS Chi squared analysis of dichotomised data will be performed. T test&#xD;
           and Mann Whitney U tests will be performed to assess differences between the pre and&#xD;
           post education programme results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 5, 2019</start_date>
  <completion_date type="Anticipated">July 5, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 5, 2019</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>Time of functional recovery from surgery</measure>
    <time_frame>90 days</time_frame>
    <description>Time to achieve discharge criteria post-operatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>90 days</time_frame>
    <description>Post operative complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>90 days</time_frame>
    <description>Adherence rates to ERAS protocol and individual ERAS components</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>90 days</time_frame>
    <description>Time in hospital after surgery</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Liver Diseases</condition>
  <condition>Pancreas Disease</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HPB resection</intervention_name>
    <description>:Liver and Pancreas surgery - Compliance with ERAS protocol</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Those patients to be included will be identified from the theatre schedule as listed for&#xD;
        HPB resectional surgery. Their compliance with the ERAS protocol will then be observed over&#xD;
        the course of their stay.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing open HPB resectional surgery within the HPB unit at the Royal&#xD;
             Infirmary of Edinburgh&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Laparoscopic surgery Non resectional surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Michael J Hughes</last_name>
    <phone>07734429759</phone>
    <email>michaelh@doctors.net.uk</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</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>Liver Diseases</mesh_term>
    <mesh_term>Pancreatic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03772392
org study id: 18185
nct id: NCT03772392
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
ERAS protocols have been utilized extensively in abdominal and non abdominal surgery over the
      past 20 years. These protocols incorporate evidence based, multi-disciplinary peri-operative
      care components. Compliance with these protocols is associated with reduced length of stay,
      reduced morbidity and reduced hospital costs.

      ERAS protocols within HPB units are les well established with less evidence supporting their
      use. Liver resection protocols are increasing in use, but ERAS post Whipples resection is
      less established.

      In the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a
      recent audit identified that that the compliance rate is low with compliance rates as low as
      30 per cent in some care domains.
1.1 Background

      Enhanced Recovery After Surgery(ERAS) protocols have been utilized extensively in abdominal
      and non abdominal surgery over the past 20 years. These protocols incorporate evidence based,
      multi-disciplinary peri-operative care components. Compliance with these protocols is
      associated with reduced length of stay, reduced morbidity and reduced hospital costs.

      ERAS protocols within hepatobiliary pancreatic (HPB) units are les well established with less
      evidence supporting their use. Liver resection protocols are increasing in use, but ERAS post
      Whipples resection is less established.

      1.2 RATIONALE FOR STUDY

      In the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a
      recent audit identified that that the compliance rate is low with compliance rates as low as
      30 per cent in some care domains.

      2. OBJECTIVES

      To compare the compliance of ERAS protocol care components within an HPB unit before and
      after an education programme.

      3. STUDY POPULATION

      3.1 NUMBER OF PARTICIPANTS An attempt to observe 100 patients will be made over the study
      period. A preliminary audit of 27 patients has been performed.

      4. PARICIPANT SELECTION

      4.1 IDENTIFYING PARTICIPANTS

      Those patients to be included will be identified from the theatre schedule as listed for HPB
      resectional surgery. Their compliance with the ERAS protocol will then be observed over the
      course of their stay.

      4.2 CONSENT The ERAS protocol is part of the unit policy and so patients will not be
      undergoing any intervention that is not already part of normal practice and consent.
      Therefore further or additional consent will not be required.

      5. DATA COLLECTION Over a six month period the compliance to the ERAS protocol will be
      assessed in patients undergoing HPB resections.

      Compliance programme

        1. Patients will be given an information leaflet describing their post-operative care
           pathway

        2. Nursing and medical staff will receive education regarding the ERAS protocol and
           achievements

        3. Auditing of the ERAS protocol adherence will subsequently be performed

      Outcome measures

        1. Functional recovery

        2. Morbidity

        3. Compliance rate of the individual peri-operative care components

        4. Drop out rate

        5. Length of stay

        6. STATISTICAL ANALYSIS Chi squared analysis of dichotomised data will be performed. T test
           and Mann Whitney U tests will be performed to assess differences between the pre and
           post education programme results.
observational model: Cohort
time perspective: Prospective
measure: Time of functional recovery from surgery
time frame: 90 days
description: Time to achieve discharge criteria post-operatively
measure: Morbidity
time frame: 90 days
description: Post operative complications
measure: Compliance
time frame: 90 days
description: Adherence rates to ERAS protocol and individual ERAS components
measure: Length of Stay
time frame: 90 days
description: Time in hospital after surgery
intervention type: Procedure
intervention name: HPB resection
description: :Liver and Pancreas surgery - Compliance with ERAS protocol
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Michael J Hughes
phone: 07734429759
email: michaelh@doctors.net.uk
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Pancreatic Diseases
sharing ipd: Undecided