<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/NCT04409899</url>
  </required_header>
  <id_info>
    <org_study_id>FundacióPuigvert</org_study_id>
    <nct_id>NCT04409899</nct_id>
  </id_info>
  <brief_title>The Utility of Enhanced Pre and Post-surgical Work-out to Prevent the Spread of COVID-19 in a Large Urology Department</brief_title>
  <acronym>UroCovid</acronym>
  <official_title>The Utility of Enhanced Pre- and Post-surgical Protocols to Prevent the Spread of COVID-19 in a Large Urological Department (UroCovid Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio Puigvert</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacio Puigvert</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>
      Since the outbreak of COVID-19 hit Spain in March 2020, most of the elective surgeries have&#xD;
      been canceled everywhere. As soon as the epidemiology phase of the pandemic changed and the&#xD;
      restrictions have been eased, different protocols have been put in place to screen patients&#xD;
      for SARS-CoV-2 before surgery in order to reduce the spreading of the disease in hospitalized&#xD;
      patients. To the best of the current state of knowledge, no recommendations or protocols have&#xD;
      been established to guide surgeons in dealing with patients developing unspecific symptoms&#xD;
      after surgeries, which could sign either of a post-op complication or COVID-19. The&#xD;
      investigators have developed an enhanced pre and post-surgical protocol both to screen&#xD;
      patients for COVID-19 before surgery and to promptly identify those patients suspicious for&#xD;
      the viral infection during the post-op.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pandemic outbreak of SARS-CoV-2 has put significant strain on the hospitals of many&#xD;
      countries around the world. Spain has been one of the countries most affected by the&#xD;
      COVID-19, with nearly 30 thousands of confirmed deaths as by 23rd of May 2020.&#xD;
&#xD;
      While the state of emergency was declared by the Spanish government at the beginning of March&#xD;
      2020, the Intensive Care Units of the larger Spanish cities were overwhelmed by the number of&#xD;
      patients in need of invasive respiratory supports. Moreover, data from China revealed that&#xD;
      patients undergoing surgery and being SARS-CoV-2 carriers were at higher risk for&#xD;
      complications and fatalities. As a result, most of the elective surgeries have been canceled&#xD;
      in all surgical disciplines. As far as it concerned the urology patients, recommendations&#xD;
      were provided by the European Association of Urology in order to guide the selection of the&#xD;
      surgeries to be prioritized. Further recommendations on how to screen patients before&#xD;
      surgeries were released by other national and international scientific societies and&#xD;
      regulatory boards.&#xD;
&#xD;
      However, regardless of a successful pre-operative screening with patients being cleared of&#xD;
      COVID-19, there might be still the possibility the patients could incubate the virus during&#xD;
      hospitalization or getting it in the hospital from other patients, visitors or professionals.&#xD;
&#xD;
      To the best of the current state of knowledge, no recommendations have been published on how&#xD;
      to guide the decision-making process on patients developing postoperatively unspecific&#xD;
      symptoms (fever, chest pain, oxygen desaturation, etc) which could raise suspicions for&#xD;
      COVID-19 during the outbreak of the disease.&#xD;
&#xD;
      The Institutional site of the investigators is a monographic hospital fully dedicated to&#xD;
      urology and nephrology, and work in close cooperation with one of the four larger public&#xD;
      hospitals in Barcelona; this latter has been one of those hospitals under significant strain&#xD;
      for the COVID-19 emergency, while the former was marginally involved by the pandemic wave.&#xD;
      The urological surgical activities never stopped during the outbreak, though initially were&#xD;
      severely reduced; after experiencing some post-operative severe complications in patients&#xD;
      developing concomitantly the SARS-CoV-2 infection, the investigators developed an enhanced&#xD;
      pre and post-surgical protocol having a twofold objective: 1) to limit the risk to intervene&#xD;
      patients harbouring the SARS-CoV-2 by undertaking an RT-PCR test 48 hours before surgery, and&#xD;
      screening for symptoms compatible with COVID-19 and/or for strict contacts with infected&#xD;
      people; furthermore, an X-ray thorax, and serum D-dimer and C-Reactive Protein were&#xD;
      undertaken to establish baseline values. 2) to establish a post-surgical algorithm to guide&#xD;
      surgeons on the nature of unspecific (and common) symptoms that could overlook for COVID-19&#xD;
      or rather raise unnecessary alarms for the viral infection, by performing serum/blood and&#xD;
      imaging tests.&#xD;
&#xD;
      As soon as the protocol was put in action, data have been recorded prospectively in a&#xD;
      registry in order to evaluate the utility of such a strategy. The recruitment period has been&#xD;
      planned to embrace only the acute phase of the pandemic; the investigators hypothesize that&#xD;
      such enhanced work-out may reduce the hospital contamination and optimal patient care in the&#xD;
      acute phase of the COVID-19 pandemic as well as in its future waves, especially in those&#xD;
      urological or surgical sites where activities have not been discontinued.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 20, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Rate of SARS-CoV-2/COVID-19 in a selected cohort of urological patients undergoing surgery</measure>
    <time_frame>Day 1 pre-op up to day-30 post-op</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative COVID-19 related complication rates</measure>
    <time_frame>Day 1 pre-op up to day-30 post-op</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between post-surgery inflammatory indexes and COVID-19 diagnosis during hospitalization</measure>
    <time_frame>Up to day-30 post-op</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>COVID-19</condition>
  <condition>Urologic Diseases</condition>
  <condition>Surgery--Complications</condition>
  <condition>Epidemic Disease</condition>
  <arm_group>
    <arm_group_label>Urological surgical patients during COVID-19 pandemic</arm_group_label>
    <description>During the COVID-19 pandemic, the urological patients in the need of a surgical intervention have been screened on the basis of the underline conditions, the priority of surgery, and risk-benefit assessment. A pre-surgical work-out was performed in the selected patients, with some of them being detected of COVID-19 at RT-PCR or suspected for it according to the risk-assessment survey. Enhanced blood tests and X-rays of the thorax were performed as baseline assessments. In case of development of post-surgical unspecific symptoms, clinical and laboratory work-out were performed before to expedite a new RT-PCR, which would have required preventive isolation of a patient in a COVID-19 ward. We evaluated the impact of COVID-19 in this selected cohort and the complications eventually associated with the viral infection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood tests</intervention_name>
    <description>RT-PCR, D-dimer, CRP, procalcitonin, ferritin, complete haemogram</description>
    <arm_group_label>Urological surgical patients during COVID-19 pandemic</arm_group_label>
    <other_name>RT-PCR</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in a waiting list for a urological surgery and selected to undertake the&#xD;
        intervention during COVID-19 pandemic according to priority and risk/benefit assessment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients selected for urological surgery during COVID-19 pandemic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients admitted in the hospital not undergoing surgical intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesco Sanguedolce, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundacio Puigvert</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fundacio Puigvert</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/</url>
    <description>World Health Organization. COVID-19 Situation Report</description>
  </link>
  <reference>
    <citation>Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.</citation>
    <PMID>32171076</PMID>
  </reference>
  <reference>
    <citation>Shang W, Dong J, Ren Y, Tian M, Li W, Hu J, Li Y. The value of clinical parameters in predicting the severity of COVID-19. J Med Virol. 2020 Oct;92(10):2188-2192. doi: 10.1002/jmv.26031. Epub 2020 Jun 2.</citation>
    <PMID>32436996</PMID>
  </reference>
  <reference>
    <citation>Lippi G, Plebani M. Procalcitonin in patients with severe coronavirus disease 2019 (COVID-19): A meta-analysis. Clin Chim Acta. 2020 Jun;505:190-191. doi: 10.1016/j.cca.2020.03.004. Epub 2020 Mar 4. No abstract available.</citation>
    <PMID>32145275</PMID>
  </reference>
  <reference>
    <citation>Stensland KD, Morgan TM, Moinzadeh A, Lee CT, Briganti A, Catto JWF, Canes D. Considerations in the Triage of Urologic Surgeries During the COVID-19 Pandemic. Eur Urol. 2020 Jun;77(6):663-666. doi: 10.1016/j.eururo.2020.03.027. Epub 2020 Apr 9.</citation>
    <PMID>32279903</PMID>
  </reference>
  <reference>
    <citation>Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, Zhan LY, Jia Y, Zhang L, Liu D, Xia ZY, Xia Z. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine. 2020 Apr 5;21:100331. doi: 10.1016/j.eclinm.2020.100331. eCollection 2020 Apr.</citation>
    <PMID>32292899</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundacio Puigvert</investigator_affiliation>
    <investigator_full_name>Francesco Sanguedolce</investigator_full_name>
    <investigator_title>MD, PhD, FEBU</investigator_title>
  </responsible_party>
  <keyword>Pre-surgical screening</keyword>
  <keyword>Post-surgical work out</keyword>
  <keyword>Urological surgery</keyword>
  <keyword>Nosocomial COVID-19 incidence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Urologic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>At the moment there is no plan to share data, but it could be considered in case of need</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/NCT04409899
org study id: FundacióPuigvert
nct id: NCT04409899
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since the outbreak of COVID-19 hit Spain in March 2020, most of the elective surgeries have
      been canceled everywhere. As soon as the epidemiology phase of the pandemic changed and the
      restrictions have been eased, different protocols have been put in place to screen patients
      for SARS-CoV-2 before surgery in order to reduce the spreading of the disease in hospitalized
      patients. To the best of the current state of knowledge, no recommendations or protocols have
      been established to guide surgeons in dealing with patients developing unspecific symptoms
      after surgeries, which could sign either of a post-op complication or COVID-19. The
      investigators have developed an enhanced pre and post-surgical protocol both to screen
      patients for COVID-19 before surgery and to promptly identify those patients suspicious for
      the viral infection during the post-op.
The pandemic outbreak of SARS-CoV-2 has put significant strain on the hospitals of many
      countries around the world. Spain has been one of the countries most affected by the
      COVID-19, with nearly 30 thousands of confirmed deaths as by 23rd of May 2020.

      While the state of emergency was declared by the Spanish government at the beginning of March
      2020, the Intensive Care Units of the larger Spanish cities were overwhelmed by the number of
      patients in need of invasive respiratory supports. Moreover, data from China revealed that
      patients undergoing surgery and being SARS-CoV-2 carriers were at higher risk for
      complications and fatalities. As a result, most of the elective surgeries have been canceled
      in all surgical disciplines. As far as it concerned the urology patients, recommendations
      were provided by the European Association of Urology in order to guide the selection of the
      surgeries to be prioritized. Further recommendations on how to screen patients before
      surgeries were released by other national and international scientific societies and
      regulatory boards.

      However, regardless of a successful pre-operative screening with patients being cleared of
      COVID-19, there might be still the possibility the patients could incubate the virus during
      hospitalization or getting it in the hospital from other patients, visitors or professionals.

      To the best of the current state of knowledge, no recommendations have been published on how
      to guide the decision-making process on patients developing postoperatively unspecific
      symptoms (fever, chest pain, oxygen desaturation, etc) which could raise suspicions for
      COVID-19 during the outbreak of the disease.

      The Institutional site of the investigators is a monographic hospital fully dedicated to
      urology and nephrology, and work in close cooperation with one of the four larger public
      hospitals in Barcelona; this latter has been one of those hospitals under significant strain
      for the COVID-19 emergency, while the former was marginally involved by the pandemic wave.
      The urological surgical activities never stopped during the outbreak, though initially were
      severely reduced; after experiencing some post-operative severe complications in patients
      developing concomitantly the SARS-CoV-2 infection, the investigators developed an enhanced
      pre and post-surgical protocol having a twofold objective: 1) to limit the risk to intervene
      patients harbouring the SARS-CoV-2 by undertaking an RT-PCR test 48 hours before surgery, and
      screening for symptoms compatible with COVID-19 and/or for strict contacts with infected
      people; furthermore, an X-ray thorax, and serum D-dimer and C-Reactive Protein were
      undertaken to establish baseline values. 2) to establish a post-surgical algorithm to guide
      surgeons on the nature of unspecific (and common) symptoms that could overlook for COVID-19
      or rather raise unnecessary alarms for the viral infection, by performing serum/blood and
      imaging tests.

      As soon as the protocol was put in action, data have been recorded prospectively in a
      registry in order to evaluate the utility of such a strategy. The recruitment period has been
      planned to embrace only the acute phase of the pandemic; the investigators hypothesize that
      such enhanced work-out may reduce the hospital contamination and optimal patient care in the
      acute phase of the COVID-19 pandemic as well as in its future waves, especially in those
      urological or surgical sites where activities have not been discontinued.
observational model: Cohort
time perspective: Prospective
measure: Rate of SARS-CoV-2/COVID-19 in a selected cohort of urological patients undergoing surgery
time frame: Day 1 pre-op up to day-30 post-op
measure: Post-operative COVID-19 related complication rates
time frame: Day 1 pre-op up to day-30 post-op
measure: Association between post-surgery inflammatory indexes and COVID-19 diagnosis during hospitalization
time frame: Up to day-30 post-op
arm group label: Urological surgical patients during COVID-19 pandemic
description: During the COVID-19 pandemic, the urological patients in the need of a surgical intervention have been screened on the basis of the underline conditions, the priority of surgery, and risk-benefit assessment. A pre-surgical work-out was performed in the selected patients, with some of them being detected of COVID-19 at RT-PCR or suspected for it according to the risk-assessment survey. Enhanced blood tests and X-rays of the thorax were performed as baseline assessments. In case of development of post-surgical unspecific symptoms, clinical and laboratory work-out were performed before to expedite a new RT-PCR, which would have required preventive isolation of a patient in a COVID-19 ward. We evaluated the impact of COVID-19 in this selected cohort and the complications eventually associated with the viral infection.
intervention type: Diagnostic Test
intervention name: Blood tests
description: RT-PCR, D-dimer, CRP, procalcitonin, ferritin, complete haemogram
arm group label: Urological surgical patients during COVID-19 pandemic
other name: RT-PCR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Francesco Sanguedolce, MD, PhD
role: Principal Investigator
affiliation: Fundacio Puigvert
facility: 
country: Spain
url: http://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/
description: World Health Organization. COVID-19 Situation Report
citation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
PMID: 32171076
citation: Shang W, Dong J, Ren Y, Tian M, Li W, Hu J, Li Y. The value of clinical parameters in predicting the severity of COVID-19. J Med Virol. 2020 Oct;92(10):2188-2192. doi: 10.1002/jmv.26031. Epub 2020 Jun 2.
PMID: 32436996
citation: Lippi G, Plebani M. Procalcitonin in patients with severe coronavirus disease 2019 (COVID-19): A meta-analysis. Clin Chim Acta. 2020 Jun;505:190-191. doi: 10.1016/j.cca.2020.03.004. Epub 2020 Mar 4. No abstract available.
PMID: 32145275
citation: Stensland KD, Morgan TM, Moinzadeh A, Lee CT, Briganti A, Catto JWF, Canes D. Considerations in the Triage of Urologic Surgeries During the COVID-19 Pandemic. Eur Urol. 2020 Jun;77(6):663-666. doi: 10.1016/j.eururo.2020.03.027. Epub 2020 Apr 9.
PMID: 32279903
citation: Lei S, Jiang F, Su W, Chen C, Chen J, Mei W, Zhan LY, Jia Y, Zhang L, Liu D, Xia ZY, Xia Z. Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period of COVID-19 infection. EClinicalMedicine. 2020 Apr 5;21:100331. doi: 10.1016/j.eclinm.2020.100331. eCollection 2020 Apr.
PMID: 32292899
responsible party type: Principal Investigator
investigator affiliation: Fundacio Puigvert
investigator full name: Francesco Sanguedolce
investigator title: MD, PhD, FEBU
mesh term: COVID-19
mesh term: Urologic Diseases
sharing ipd: Undecided
ipd description: At the moment there is no plan to share data, but it could be considered in case of need