<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/NCT04493710</url>
  </required_header>
  <id_info>
    <org_study_id>Sarco1</org_study_id>
    <nct_id>NCT04493710</nct_id>
  </id_info>
  <brief_title>Retrospective Analysis of Sarcopenia in Older Patients Undergoing Laparotomy</brief_title>
  <official_title>Retrospective Analysis of Sarcopenia in Older Patients Undergoing Laparotomy-</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wirral University Teaching Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wirral University Teaching Hospital NHS Trust</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>
      Assess the influence of sarcopenia on outcomes of emergency laparotomy in the over 65 age&#xD;
      group&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emergency laparotomy is associated with substantial morbidity and mortality. These risks are&#xD;
      increased in the elderly population with a third of over-80s dying within thirty days of&#xD;
      surgery, rising to 50% at 1-year post emergency laparotomy. Many patients are frail and have&#xD;
      multiple co-morbidities, often with coexistent malnutrition and so present a significant&#xD;
      challenge in the emergency surgery setting. The National Emergency Laparotomy Audit has&#xD;
      reported that greater than half of patients undergoing emergency laparotomy in the UK are&#xD;
      over-65 years of age and are the highest risk patients with the highest mortality. This&#xD;
      group, therefore, is one in which accurate prognostication is desirable to allow optimal&#xD;
      treatment decisions, provision of critical care treatment, and resource allocation.&#xD;
&#xD;
      A number of multivariate risk prediction models exist including POSSUM, P-POSSUM and&#xD;
      APACHE-II with on-going modification of P-POSSUM as part of the National Emergency Laparotomy&#xD;
      Audit(NELA). Whilst such models are commonly used, evidence suggests that they may be less&#xD;
      accurate in elderly patients, a group which offer difficult decision-making problems to the&#xD;
      surgeon&#xD;
&#xD;
      . Frailty is the lack of physiological functional reserve and is commonplace in elderly&#xD;
      patients. It has profound effects on the ability to withstand and recover from emergency&#xD;
      surgery. Despite this, frailty does not form part of the commonly used multivariate risk&#xD;
      prediction models.&#xD;
&#xD;
      Sarcopenia is the progressive and global loss of skeletal muscle mass as well as reduction in&#xD;
      strength and is closely linked to frailty. Multiple methods of quantifying skeletal muscle&#xD;
      mass and therefore sarcopenia have been defined, but calculation of psoas major&#xD;
      cross-sectional area on pre-operative CT imaging may be the most pragmatic in the emergency&#xD;
      setting due to routine use of pre-operative CT imaging prior to emergency laparotomy.&#xD;
      Measurement of the psoas major as a marker of sarcopenia has been shown to predict outcomes&#xD;
      in a wide range of surgical specialties. However, there is no consensus as to how this marker&#xD;
      of sarcopenia should be used in surgical practice.&#xD;
&#xD;
      Proposal- To assess the utility of psoas major measurement to predict outcomes following&#xD;
      emergency laparotomy in older patients and whether it could enhance the accuracy of mortality&#xD;
      prediction when combined with P-POSSUM model variables.&#xD;
&#xD;
      Methods An analysis of data collected as part of the National Emergency Laparotomy Audit was&#xD;
      conducted. Data were collected from patients over the age of 65 who underwent emergency&#xD;
      laparotomy in Merseyside, United Kingdom between 2014 and 2018. Patients who underwent&#xD;
      pre-operative cross-sectional imaging with abdominal CT pre-operatively were included in the&#xD;
      analysis.&#xD;
&#xD;
      Demographic, histological, clinical, biochemical and operative data were collected and&#xD;
      analysed by accessing patient clinical notes and electronic records.&#xD;
&#xD;
      Outcome measures included inpatient mortality, 30-day mortality and 90-day mortality.&#xD;
&#xD;
      Radiological Analysis Pre-operative CT imaging of the abdomen were accessed and analysed.&#xD;
      Cross-sectional images at the level of the L3 inferior end plate were analysed.&#xD;
      Cross-sectional area of the psoas major and L3 vertebral body (mm2) were calculated and a&#xD;
      ratio of psoas major to L3 cross-sectional area calculated (PML3) . Higher PML3 values&#xD;
      indicate higher levels of skeletal muscle mass. Cross-sectional area calculation was&#xD;
      conducted using the area of interest tool.&#xD;
&#xD;
      Statistical Analysis Statistical analysis for continuous variables was conducted using&#xD;
      Mann-Whitney U test and Chi-squared test for categorical variables. Receiver operating&#xD;
      characteristics curves were used for analysis of association of PML3 with mortality.&#xD;
&#xD;
      Multivariate analysis was conducted using binary logistic regression analysis. Logistic&#xD;
      regression models were produced including P-POSSUM variables with and without the inclusion&#xD;
      of PML3. Receiver operating characteristic analysis of the respective logistic regression&#xD;
      models were conducted to assess whether the addition of PML3 enhanced mortality prediction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Number of participants who die between zero and thirty days</measure>
    <time_frame>30 days</time_frame>
    <description>Post-operative death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who die between zero and ninety days</measure>
    <time_frame>90 days</time_frame>
    <description>Post-operative death</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Frailty</condition>
  <condition>Surgery</condition>
  <condition>Emergencies</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sarcopenia estimation</intervention_name>
    <description>Analysis of pre-existing CT imaging</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing emergency laparotomy aged 65 or over&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 65 or over having emergency laparotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Conor Magee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wirral University Teaching Hospitals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Conor Magee, MD</last_name>
    <phone>+441516785111</phone>
    <email>conormagee@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Greg Simpson, FRCS</last_name>
    <phone>+441516785111</phone>
    <email>gregorysimpson@doctors.org.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>WUTH</name>
      <address>
        <city>Upton</city>
        <state>Wirral</state>
        <zip>CH49 5PE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Conor Magee, MD</last_name>
      <phone>01516785111</phone>
    </contact>
    <investigator>
      <last_name>Greg Simpson, MB CHB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wirral University Teaching Hospital NHS Trust</investigator_affiliation>
    <investigator_full_name>Conor Magee</investigator_full_name>
    <investigator_title>Consultant Surgeon</investigator_title>
  </responsible_party>
  <keyword>surgery</keyword>
  <keyword>laparotomy</keyword>
  <keyword>emergency</keyword>
  <keyword>sarcopenia</keyword>
  <keyword>frailty</keyword>
  <keyword>mortality</keyword>
  <keyword>risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04493710
org study id: Sarco1
nct id: NCT04493710
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assess the influence of sarcopenia on outcomes of emergency laparotomy in the over 65 age
      group
Emergency laparotomy is associated with substantial morbidity and mortality. These risks are
      increased in the elderly population with a third of over-80s dying within thirty days of
      surgery, rising to 50% at 1-year post emergency laparotomy. Many patients are frail and have
      multiple co-morbidities, often with coexistent malnutrition and so present a significant
      challenge in the emergency surgery setting. The National Emergency Laparotomy Audit has
      reported that greater than half of patients undergoing emergency laparotomy in the UK are
      over-65 years of age and are the highest risk patients with the highest mortality. This
      group, therefore, is one in which accurate prognostication is desirable to allow optimal
      treatment decisions, provision of critical care treatment, and resource allocation.

      A number of multivariate risk prediction models exist including POSSUM, P-POSSUM and
      APACHE-II with on-going modification of P-POSSUM as part of the National Emergency Laparotomy
      Audit(NELA). Whilst such models are commonly used, evidence suggests that they may be less
      accurate in elderly patients, a group which offer difficult decision-making problems to the
      surgeon

      . Frailty is the lack of physiological functional reserve and is commonplace in elderly
      patients. It has profound effects on the ability to withstand and recover from emergency
      surgery. Despite this, frailty does not form part of the commonly used multivariate risk
      prediction models.

      Sarcopenia is the progressive and global loss of skeletal muscle mass as well as reduction in
      strength and is closely linked to frailty. Multiple methods of quantifying skeletal muscle
      mass and therefore sarcopenia have been defined, but calculation of psoas major
      cross-sectional area on pre-operative CT imaging may be the most pragmatic in the emergency
      setting due to routine use of pre-operative CT imaging prior to emergency laparotomy.
      Measurement of the psoas major as a marker of sarcopenia has been shown to predict outcomes
      in a wide range of surgical specialties. However, there is no consensus as to how this marker
      of sarcopenia should be used in surgical practice.

      Proposal- To assess the utility of psoas major measurement to predict outcomes following
      emergency laparotomy in older patients and whether it could enhance the accuracy of mortality
      prediction when combined with P-POSSUM model variables.

      Methods An analysis of data collected as part of the National Emergency Laparotomy Audit was
      conducted. Data were collected from patients over the age of 65 who underwent emergency
      laparotomy in Merseyside, United Kingdom between 2014 and 2018. Patients who underwent
      pre-operative cross-sectional imaging with abdominal CT pre-operatively were included in the
      analysis.

      Demographic, histological, clinical, biochemical and operative data were collected and
      analysed by accessing patient clinical notes and electronic records.

      Outcome measures included inpatient mortality, 30-day mortality and 90-day mortality.

      Radiological Analysis Pre-operative CT imaging of the abdomen were accessed and analysed.
      Cross-sectional images at the level of the L3 inferior end plate were analysed.
      Cross-sectional area of the psoas major and L3 vertebral body (mm2) were calculated and a
      ratio of psoas major to L3 cross-sectional area calculated (PML3) . Higher PML3 values
      indicate higher levels of skeletal muscle mass. Cross-sectional area calculation was
      conducted using the area of interest tool.

      Statistical Analysis Statistical analysis for continuous variables was conducted using
      Mann-Whitney U test and Chi-squared test for categorical variables. Receiver operating
      characteristics curves were used for analysis of association of PML3 with mortality.

      Multivariate analysis was conducted using binary logistic regression analysis. Logistic
      regression models were produced including P-POSSUM variables with and without the inclusion
      of PML3. Receiver operating characteristic analysis of the respective logistic regression
      models were conducted to assess whether the addition of PML3 enhanced mortality prediction.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of participants who die between zero and thirty days
time frame: 30 days
description: Post-operative death
measure: Number of participants who die between zero and ninety days
time frame: 90 days
description: Post-operative death
intervention type: Diagnostic Test
intervention name: Sarcopenia estimation
description: Analysis of pre-existing CT imaging
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 110 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Conor Magee, MD
role: Principal Investigator
affiliation: Wirral University Teaching Hospitals
last name: Conor Magee, MD
phone: +441516785111
email: conormagee@nhs.net
last name: Greg Simpson, FRCS
phone: +441516785111
email: gregorysimpson@doctors.org.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Wirral University Teaching Hospital NHS Trust
investigator full name: Conor Magee
investigator title: Consultant Surgeon
mesh term: Sarcopenia
mesh term: Emergencies
mesh term: Frailty
sharing ipd: No