<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/NCT03279588</url>
  </required_header>
  <id_info>
    <org_study_id>11004</org_study_id>
    <nct_id>NCT03279588</nct_id>
  </id_info>
  <brief_title>Diagnostic Accuracy of Bedside Ultrasound in Suspected Acute Diverticulitis</brief_title>
  <official_title>Diagnostic Accuracy and Role of Bedside Ultrasound in Patients With Suspected Acute Diverticulitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliero-Universitaria Careggi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliero-Universitaria Careggi</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>
      Colonic diverticulitis is a common clinical condition in patients presenting to the Emergency&#xD;
      Department (ED) with abdominal pain. The diagnosis and staging of patients with suspected&#xD;
      acute diverticulitis is often made by CT imaging with intravenous contrast, which involves&#xD;
      radiation exposure, is expensive and has contraindications. The aim of this study is to&#xD;
      evaluate the diagnostic accuracy and role of bedside abdominal US for the diagnosis of acute&#xD;
      diverticulitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colonic diverticulitis is a common clinical condition; about 20% of patients with colonic&#xD;
      diverticulosis experience abdominal symptoms and, eventually, complications such as episodes&#xD;
      of diverticulitis or bleeding. The distinction between patients with uncomplicated or&#xD;
      complicated diverticulitis affects the clinical management: medical therapy for the first,&#xD;
      interventional therapy for the latter. CT imaging with intravenous contrast has become the&#xD;
      gold standard in the diagnosis and staging of patients with suspected acute diverticulitis&#xD;
      but, unfortunately, CT involves radiation exposure, is expensive and has contraindications.&#xD;
      UltraSound (US) is a real-time dynamic examination with wide availability and easy&#xD;
      accessibility and may be useful in diagnosing and managing critically ill patients who cannot&#xD;
      be moved to CT. In a recent meta-analysis, US exam performed by Radiologists showed a pooled&#xD;
      sensitivity of 90% (vs 95% for CT, p = 0.86) and a specificity of 90% (vs 96% for CT, p =&#xD;
      0.04). US is increasingly used at bedside to rapidly assess patients presenting to the&#xD;
      Emergency Department. No previous studies have investigated the diagnostic accuracy of&#xD;
      abdominal US performed by physician at bedside as an extension of physical examination. This&#xD;
      study evaluates the diagnostic accuracy of bedside abdominal US.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2017</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</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>Accuracy of bedside abdominal US performed by Emergency Physicians for the diagnosis and stratification of acute diverticulitis</measure>
    <time_frame>30 days</time_frame>
    <description>Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of bedside abdominal US performed by Emergency Physicians for the diagnosis of acute diverticulitis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Management of patient</measure>
    <time_frame>30 days</time_frame>
    <description>To evaluate the reliability of the management proposed by the ultrasonographer on the basis of clinical, laboratoristic and ultrasonographic data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time reduction</measure>
    <time_frame>30 days</time_frame>
    <description>To evaluate if the use of bedside abdominal US performed by Emergency Physicians can reduce the time needed for the diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CT scan reduction</measure>
    <time_frame>30 days</time_frame>
    <description>To evaluate if the use of bedside abdominal US performed by Emergency Physicians can raduce the number of CT scans performed in patients with suspected acute diverticulitis</description>
  </secondary_outcome>
  <enrollment type="Actual">400</enrollment>
  <condition>Acute Diverticulitis</condition>
  <condition>Abdominal Pain</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Bedside Ultrasound</intervention_name>
    <description>Patients presenting to the Emergency Department with abdominal pain suspected of acute diverticulitis are evaluated with standard care by an Emergency Physician (tutor); at the time the tutor requests an imaging test performed by Radiologist (CT scan or US scan), he notifies another physicians skilled in bedside abdominal US (ultrasonographer), who evaluates the patient and performs the US scan. Ultrasonographer after completation of US and knowing blood samples results fills in a standardized form reporting the diagnostic hypotesis, the need for additional work-up (if deemed necessary), and the disposition of the patient. The standardized form completed by the ultrasonographer will be compared with the actual management of the patient.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Every patient presenting with symptoms suspected of diverticular disease to the Emergency&#xD;
        Department of four Italian hospitals will be considered eligible for the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent obtained&#xD;
&#xD;
          -  patients with abdominal pain presenting to the Emergency Department with a suspicon of&#xD;
             diverticular disease, in whom the tutor physician orders an imaging study (abdominal&#xD;
             CT or abdominal US performed by the Radiologist)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no ultrasonographer physician who can perform bedside abdominal US is present&#xD;
&#xD;
          -  the patient does not undergo imaging study&#xD;
&#xD;
          -  clinical conditions of the patient are particularly severe, preventing an adequate&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Peiman Nazerian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Departmet Azienda Ospedaliero Universitaria Careggi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Emergency Medicine</name>
      <address>
        <city>Figline Valdarno</city>
        <state>Firenze</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Department Azienda Ospedaliera Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <state>Tuscany</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Department ASST degli Spedali Civili di Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Department Nuovo Ospedale di Prato</name>
      <address>
        <city>Prato</city>
        <zip>59100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Sartelli M, Catena F, Ansaloni L, Coccolini F, Griffiths EA, Abu-Zidan FM, Di Saverio S, Ulrych J, Kluger Y, Ben-Ishay O, Moore FA, Ivatury RR, Coimbra R, Peitzman AB, Leppaniemi A, Fraga GP, Maier RV, Chiara O, Kashuk J, Sakakushev B, Weber DG, Latifi R, Biffl W, Bala M, Karamarkovic A, Inaba K, Ordonez CA, Hecker A, Augustin G, Demetrashvili Z, Melo RB, Marwah S, Zachariah SK, Shelat VG, McFarlane M, Rems M, Gomes CA, Faro MP, Junior GA, Negoi I, Cui Y, Sato N, Vereczkei A, Bellanova G, Birindelli A, Di Carlo I, Kok KY, Gachabayov M, Gkiokas G, Bouliaris K, Colak E, Isik A, Rios-Cruz D, Soto R, Moore EE. WSES Guidelines for the management of acute left sided colonic diverticulitis in the emergency setting. World J Emerg Surg. 2016 Jul 29;11:37. doi: 10.1186/s13017-016-0095-0. eCollection 2016.</citation>
    <PMID>27478494</PMID>
  </reference>
  <reference>
    <citation>Cuomo R, Barbara G, Pace F, Annese V, Bassotti G, Binda GA, Casetti T, Colecchia A, Festi D, Fiocca R, Laghi A, Maconi G, Nascimbeni R, Scarpignato C, Villanacci V, Annibale B. Italian consensus conference for colonic diverticulosis and diverticular disease. United European Gastroenterol J. 2014 Oct;2(5):413-42. doi: 10.1177/2050640614547068.</citation>
    <PMID>25360320</PMID>
  </reference>
  <reference>
    <citation>Andeweg CS, Wegdam JA, Groenewoud J, van der Wilt GJ, van Goor H, Bleichrodt RP. Toward an evidence-based step-up approach in diagnosing diverticulitis. Scand J Gastroenterol. 2014 Jul;49(7):775-84. doi: 10.3109/00365521.2014.908475. Epub 2014 May 30.</citation>
    <PMID>24874087</PMID>
  </reference>
  <reference>
    <citation>Lameris W, van Randen A, Bipat S, Bossuyt PM, Boermeester MA, Stoker J. Graded compression ultrasonography and computed tomography in acute colonic diverticulitis: meta-analysis of test accuracy. Eur Radiol. 2008 Nov;18(11):2498-511. doi: 10.1007/s00330-008-1018-6. Epub 2008 Jun 4.</citation>
    <PMID>18523784</PMID>
  </reference>
  <reference>
    <citation>Liljegren G, Chabok A, Wickbom M, Smedh K, Nilsson K. Acute colonic diverticulitis: a systematic review of diagnostic accuracy. Colorectal Dis. 2007 Jul;9(6):480-8. doi: 10.1111/j.1463-1318.2007.01238.x.</citation>
    <PMID>17573739</PMID>
  </reference>
  <reference>
    <citation>Mazzei MA, Cioffi Squitieri N, Guerrini S, Stabile Ianora AA, Cagini L, Macarini L, Giganti M, Volterrani L. Sigmoid diverticulitis: US findings. Crit Ultrasound J. 2013 Jul 15;5 Suppl 1(Suppl 1):S5. doi: 10.1186/2036-7902-5-S1-S5. Epub 2013 Jul 15.</citation>
    <PMID>23902791</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>May 9, 2019</last_update_submitted>
  <last_update_submitted_qc>May 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero-Universitaria Careggi</investigator_affiliation>
    <investigator_full_name>Peiman Nazerian</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ultrasound diagnosis</keyword>
  <keyword>Abdominal Ultrasound</keyword>
  <keyword>Emergency Department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diverticulitis</mesh_term>
    <mesh_term>Abdominal Pain</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/NCT03279588
org study id: 11004
nct id: NCT03279588
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colonic diverticulitis is a common clinical condition in patients presenting to the Emergency
      Department (ED) with abdominal pain. The diagnosis and staging of patients with suspected
      acute diverticulitis is often made by CT imaging with intravenous contrast, which involves
      radiation exposure, is expensive and has contraindications. The aim of this study is to
      evaluate the diagnostic accuracy and role of bedside abdominal US for the diagnosis of acute
      diverticulitis
Colonic diverticulitis is a common clinical condition; about 20% of patients with colonic
      diverticulosis experience abdominal symptoms and, eventually, complications such as episodes
      of diverticulitis or bleeding. The distinction between patients with uncomplicated or
      complicated diverticulitis affects the clinical management: medical therapy for the first,
      interventional therapy for the latter. CT imaging with intravenous contrast has become the
      gold standard in the diagnosis and staging of patients with suspected acute diverticulitis
      but, unfortunately, CT involves radiation exposure, is expensive and has contraindications.
      UltraSound (US) is a real-time dynamic examination with wide availability and easy
      accessibility and may be useful in diagnosing and managing critically ill patients who cannot
      be moved to CT. In a recent meta-analysis, US exam performed by Radiologists showed a pooled
      sensitivity of 90% (vs 95% for CT, p = 0.86) and a specificity of 90% (vs 96% for CT, p =
      0.04). US is increasingly used at bedside to rapidly assess patients presenting to the
      Emergency Department. No previous studies have investigated the diagnostic accuracy of
      abdominal US performed by physician at bedside as an extension of physical examination. This
      study evaluates the diagnostic accuracy of bedside abdominal US.
observational model: Cohort
time perspective: Prospective
measure: Accuracy of bedside abdominal US performed by Emergency Physicians for the diagnosis and stratification of acute diverticulitis
time frame: 30 days
description: Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of bedside abdominal US performed by Emergency Physicians for the diagnosis of acute diverticulitis.
measure: Management of patient
time frame: 30 days
description: To evaluate the reliability of the management proposed by the ultrasonographer on the basis of clinical, laboratoristic and ultrasonographic data.
measure: Time reduction
time frame: 30 days
description: To evaluate if the use of bedside abdominal US performed by Emergency Physicians can reduce the time needed for the diagnosis
measure: CT scan reduction
time frame: 30 days
description: To evaluate if the use of bedside abdominal US performed by Emergency Physicians can raduce the number of CT scans performed in patients with suspected acute diverticulitis
intervention type: Diagnostic Test
intervention name: Bedside Ultrasound
description: Patients presenting to the Emergency Department with abdominal pain suspected of acute diverticulitis are evaluated with standard care by an Emergency Physician (tutor); at the time the tutor requests an imaging test performed by Radiologist (CT scan or US scan), he notifies another physicians skilled in bedside abdominal US (ultrasonographer), who evaluates the patient and performs the US scan. Ultrasonographer after completation of US and knowing blood samples results fills in a standardized form reporting the diagnostic hypotesis, the need for additional work-up (if deemed necessary), and the disposition of the patient. The standardized form completed by the ultrasonographer will be compared with the actual management of the patient.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Peiman Nazerian, MD
role: Principal Investigator
affiliation: Emergency Departmet Azienda Ospedaliero Universitaria Careggi
facility: 
facility: 
facility: 
facility: 
country: Italy
citation: Sartelli M, Catena F, Ansaloni L, Coccolini F, Griffiths EA, Abu-Zidan FM, Di Saverio S, Ulrych J, Kluger Y, Ben-Ishay O, Moore FA, Ivatury RR, Coimbra R, Peitzman AB, Leppaniemi A, Fraga GP, Maier RV, Chiara O, Kashuk J, Sakakushev B, Weber DG, Latifi R, Biffl W, Bala M, Karamarkovic A, Inaba K, Ordonez CA, Hecker A, Augustin G, Demetrashvili Z, Melo RB, Marwah S, Zachariah SK, Shelat VG, McFarlane M, Rems M, Gomes CA, Faro MP, Junior GA, Negoi I, Cui Y, Sato N, Vereczkei A, Bellanova G, Birindelli A, Di Carlo I, Kok KY, Gachabayov M, Gkiokas G, Bouliaris K, Colak E, Isik A, Rios-Cruz D, Soto R, Moore EE. WSES Guidelines for the management of acute left sided colonic diverticulitis in the emergency setting. World J Emerg Surg. 2016 Jul 29;11:37. doi: 10.1186/s13017-016-0095-0. eCollection 2016.
PMID: 27478494
citation: Cuomo R, Barbara G, Pace F, Annese V, Bassotti G, Binda GA, Casetti T, Colecchia A, Festi D, Fiocca R, Laghi A, Maconi G, Nascimbeni R, Scarpignato C, Villanacci V, Annibale B. Italian consensus conference for colonic diverticulosis and diverticular disease. United European Gastroenterol J. 2014 Oct;2(5):413-42. doi: 10.1177/2050640614547068.
PMID: 25360320
citation: Andeweg CS, Wegdam JA, Groenewoud J, van der Wilt GJ, van Goor H, Bleichrodt RP. Toward an evidence-based step-up approach in diagnosing diverticulitis. Scand J Gastroenterol. 2014 Jul;49(7):775-84. doi: 10.3109/00365521.2014.908475. Epub 2014 May 30.
PMID: 24874087
citation: Lameris W, van Randen A, Bipat S, Bossuyt PM, Boermeester MA, Stoker J. Graded compression ultrasonography and computed tomography in acute colonic diverticulitis: meta-analysis of test accuracy. Eur Radiol. 2008 Nov;18(11):2498-511. doi: 10.1007/s00330-008-1018-6. Epub 2008 Jun 4.
PMID: 18523784
citation: Liljegren G, Chabok A, Wickbom M, Smedh K, Nilsson K. Acute colonic diverticulitis: a systematic review of diagnostic accuracy. Colorectal Dis. 2007 Jul;9(6):480-8. doi: 10.1111/j.1463-1318.2007.01238.x.
PMID: 17573739
citation: Mazzei MA, Cioffi Squitieri N, Guerrini S, Stabile Ianora AA, Cagini L, Macarini L, Giganti M, Volterrani L. Sigmoid diverticulitis: US findings. Crit Ultrasound J. 2013 Jul 15;5 Suppl 1(Suppl 1):S5. doi: 10.1186/2036-7902-5-S1-S5. Epub 2013 Jul 15.
PMID: 23902791
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliero-Universitaria Careggi
investigator full name: Peiman Nazerian
investigator title: Principal Investigator
mesh term: Diverticulitis
mesh term: Abdominal Pain
sharing ipd: No