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)
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2020
CompletedFirst Submitted
Initial submission to the registry
May 26, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJuly 21, 2020
July 1, 2020
3 months
May 26, 2020
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of SARS-CoV-2/COVID-19 in a selected cohort of urological patients undergoing surgery
Day 1 pre-op up to day-30 post-op
Post-operative COVID-19 related complication rates
Day 1 pre-op up to day-30 post-op
Secondary Outcomes (1)
Association between post-surgery inflammatory indexes and COVID-19 diagnosis during hospitalization
Up to day-30 post-op
Study Arms (1)
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.
Interventions
RT-PCR, D-dimer, CRP, procalcitonin, ferritin, complete haemogram
Eligibility Criteria
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
You may qualify if:
- Patients selected for urological surgery during COVID-19 pandemic
You may not qualify if:
- Patients admitted in the hospital not undergoing surgical intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundacio Puigvert
Barcelona, 08025, Spain
Related Publications (5)
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.
PMID: 32171076BACKGROUNDShang 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: 32436996BACKGROUNDLippi 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: 32145275BACKGROUNDStensland 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: 32279903BACKGROUNDLei 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: 32292899BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Sanguedolce, MD, PhD
Fundacio Puigvert
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, FEBU
Study Record Dates
First Submitted
May 26, 2020
First Posted
June 1, 2020
Study Start
March 20, 2020
Primary Completion
June 30, 2020
Study Completion
December 31, 2020
Last Updated
July 21, 2020
Record last verified: 2020-07