- ICH GCP
- US Clinical Trials Registry
- 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 (UroCovid)
The Utility of Enhanced Pre- and Post-surgical Protocols to Prevent the Spread of COVID-19 in a Large Urological Department (UroCovid Study)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Barcelona, Spain, 08025
- Fundacio Puigvert
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients selected for urological surgery during COVID-19 pandemic
Exclusion Criteria:
- Patients admitted in the hospital not undergoing surgical intervention
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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RT-PCR, D-dimer, CRP, procalcitonin, ferritin, complete haemogram
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Day 1 pre-op up to day-30 post-op
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Post-operative COVID-19 related complication rates
Time Frame: Day 1 pre-op up to day-30 post-op
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Day 1 pre-op up to day-30 post-op
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Association between post-surgery inflammatory indexes and COVID-19 diagnosis during hospitalization
Time Frame: Up to day-30 post-op
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Up to day-30 post-op
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francesco Sanguedolce, MD, PhD, Fundacio Puigvert
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FundacióPuigvert
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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