Clinical trial NCT04409899: The Utility of Enhanced Pre and Post-surgical Work-out to Prevent the Spread of COVID-19 in a Large Urology Department
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Urologic Diseases
Surgery--Complications
Epidemic Disease
Keywords: Pre-surgical screening
Post-surgical work out
Urological surgery
Nosocomial COVID-19 incidence
Lead sponsor: Fundacio Puigvert
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

* Patients selected for urological surgery during COVID-19 pandemic

Exclusion Criteria:

* Patients admitted in the hospital not undergoing surgical intervention

Primary outcomes:
measure: Rate of SARS-CoV-2/COVID-19 in a selected cohort of urological patients undergoing surgery
timeFrame: Day 1 pre-op up to day-30 post-op
measure: Post-operative COVID-19 related complication rates
timeFrame: Day 1 pre-op up to day-30 post-op
Secondary outcomes:
measure: Association between post-surgery inflammatory indexes and COVID-19 diagnosis during hospitalization
timeFrame: Up to day-30 post-op
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundacio Puigvert
Study officials:
affiliation: Fundacio Puigvert
name: Francesco Sanguedolce, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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