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The Utility of Enhanced Pre and Post-surgical Work-out to Prevent the Spread of COVID-19 in a Large Urology Department (UroCovid)

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ClinicalTrials.gov Identifier: NCT04409899
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Francesco Sanguedolce, Fundacio Puigvert

Brief Summary:
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.

Condition or disease Intervention/treatment
COVID-19 Urologic Diseases Surgery--Complications Epidemic Disease Diagnostic Test: Blood tests

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : March 20, 2020
Actual Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
Urological surgical patients during COVID-19 pandemic
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.
Diagnostic Test: Blood tests
RT-PCR, D-dimer, CRP, procalcitonin, ferritin, complete haemogram
Other Name: RT-PCR




Primary Outcome Measures :
  1. 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 ]
  2. Post-operative COVID-19 related complication rates [ Time Frame: Day 1 pre-op up to day-30 post-op ]

Secondary Outcome Measures :
  1. Association between post-surgery inflammatory indexes and COVID-19 diagnosis during hospitalization [ Time Frame: Up to day-30 post-op ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in a waiting list for a urological surgery and selected to undertake the intervention during COVID-19 pandemic according to priority and risk/benefit assessment
Criteria

Inclusion Criteria:

  • Patients selected for urological surgery during COVID-19 pandemic

Exclusion Criteria:

  • Patients admitted in the hospital not undergoing surgical intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409899


Locations
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Spain
Fundacio Puigvert
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundacio Puigvert
Investigators
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Principal Investigator: Francesco Sanguedolce, MD, PhD Fundacio Puigvert
Additional Information:
Publications:
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Responsible Party: Francesco Sanguedolce, MD, PhD, FEBU, Fundacio Puigvert
ClinicalTrials.gov Identifier: NCT04409899    
Other Study ID Numbers: FundacióPuigvert
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: At the moment there is no plan to share data, but it could be considered in case of need

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco Sanguedolce, Fundacio Puigvert:
Pre-surgical screening
Post-surgical work out
Urological surgery
Nosocomial COVID-19 incidence
Additional relevant MeSH terms:
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Urologic Diseases