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)
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.

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.

Unknown status
COVID-19
Urologic Diseases
Surgery--Complications
Epidemic Disease

Diagnostic Test: Blood tests

RT-PCR, D-dimer, CRP, procalcitonin, ferritin, complete haemogram
Other Name: RT-PCR

Eligibility Criteria

Inclusion Criteria:

- Patients selected for urological surgery during COVID-19 pandemic

Exclusion Criteria:

- Patients admitted in the hospital not undergoing surgical intervention

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Spain
Locations

Fundacio Puigvert
Barcelona, Spain

Francesco Sanguedolce, MD, PhD, Principal Investigator
Fundacio Puigvert

Fundacio Puigvert
NCT Number
Keywords
Pre-surgical screening
Post-surgical work out
Urological surgery
Nosocomial COVID-19 incidence
MeSH Terms
COVID-19
Urologic Diseases