key: cord-0843199-k5rjjpib authors: Tejido-Sánchez, A.; González-Díaz, A.; García-Rojo, E.; Santos-Pérez de la Blanca, R.; Varela-Rodríguez, C.; Ruiz-López, P.; Rodríguez-Antolín, A. title: Design of an assistance protocol for the restart of scheduled urologic surgery in a COVID-19 epidemic period date: 2020-11-30 journal: Actas Urológicas Españolas (English Edition) DOI: 10.1016/j.acuroe.2020.10.005 sha: 8acdd4ed6e7794c87db2c0d7ec9b95c4526da636 doc_id: 843199 cord_uid: k5rjjpib Objective Design a care protocol to restart scheduled surgical activity in a Urology service of a third level hospital in the Community of Madrid, in a safe way for our patients and professionals in the context of the SARS-CoV-2 coronavirus epidemic. Material and methods A multidisciplinary group reviewed the different recommendations of the literature, national and international health organizations and scientific societies, as well as their application to our environment. Once scheduled surgery has restarted, the patients undergoing surgery for complications related to COVID-19 are being followed up. Results Since the resumption of surgical activity, 19 patients have been scheduled, of which 2 have been suspended for presenting COVID-19, one diagnosed by positive PCR for SARS-CoV-2, and another by laboratory and imaging findings compatible with this infection. With a median follow-up of 10 days (4–14 days), no complications related to COVID-19 were detected. Conclusions Preliminary results indicate that the protocol designed to ensure the correct application of preventive measures against the transmission of coronavirus infection is being safe and effective. The Community of Madrid is the most affected in our country with 71,503 cases of COVID-19 (diagnosed by PCR and antibody tests) and 8826 deaths caused by this disease (data as of May 15, 2020) . 1 This situation has forced us to change our usual practice in order to adapt to the population needs. Thus, the Hospital Universitario 12 de Octubre, one of the most complex hospitals in the Community of Madrid, with 1256 hospital beds, has dedicated most of its resources to the care of COVID-19 patients, in the same way as other health centers. The Urology department, as all surgical services in our country, 2 has had to cope with this situation, in such a way that the scheduled surgical activity was suspended as of March 16, 2020 , with only urgent surgery being performed. Meanwhile, urologists have been included in dedicated teams to provide healthcare for COVID-19 patients (hospitals and medicalized hotels), and have carried out telephone consultations for urologic patients. Currently, the overcoming of the peak of the SARS-CoV-2 coronavirus pandemic indicates the need to restart scheduled surgical activity, since for many patients the delay in their intervention may be associated with a worse prognosis or severe quality of life damage. 3---5 This requires adequate planning to ensure safe and high-quality healthcare, minimizing the risk of SARS-CoV-2 infection, which can be associated with significant complications. 6 With this objective, we set up a work group to develop a healthcare protocol, which adapts the main recommendations of scientific societies to our framework. We will present the main recommendations gathered in this protocol, as well as an analysis of its initial results. The main objective of the protocol is to organize surgical activity and adjust it to the therapeutic needs of the patients, trying to avoid delays that could imply a poor evolution of their pathology and reducing the risk of SARS-CoV-2 coronavirus infection in our patients and healthcare professionals. The specific objectives are to normalize the performance guidelines in the Surgical Services, adapting them to the best scientific evidence possible, to resource availability and to the optimization of their use, as well as to analyze the postoperative evolution of our patients. The Urology department, together with the Quality Management Unit, developed an initial workplan proposal, which was later joined by representatives of the Anesthesiology and Resuscitation services, Admissions, Preventive Medicine, Occupational Risk Prevention, Microbiology, Radiology, Clinical Analysis, Infectious Diseases Unit and members of the Medical and Nursing Directorate as well as Continuity of Care and Patient Assistance. In order to apply this protocol to all Surgical Services, representatives from all surgical specialties were involved. We reviewed the main recommendations of the surgical and anesthesiological societies (in the case of Urology we used those of the European Association of Urology 7 ), as well as the main databases (Medline and Embase), using as keywords ''COVID-19'', ''SARS-CoV-2'' and ''Surgery''. No language or publication date restrictions were applied, and the bibliographic references of the articles and documents included were reviewed. Based on the analysis performed, a consensus document was proposed and subsequently approved by the Management Committee of our hospital. We establish action guidelines according to the different stages of the process, which are summarized in Fig. 1 sures are maximized, including restricted visitors and companions (telephone information), admission to single-person rooms, limited patient movement and use of a surgical mask at all times. As for professionals, we must perform hand hygiene, wear gloves, surgical facemask and disposable gowns. 5. Operating room procedures: there is a high probability of finding COVID-19 patients without apparent symptoms and with a negative PCR result. Aiming to reduce the chances of infection among healthcare personnel, droplet and airborne transmission precautions are taken in risky procedures, such as those performed on the airway (intubation, suctioning, . . .), as well as in surgical interventions with aerosol-generating procedures or risk of blood or body fluids splashes. These measures include recommendations on personal protective equipment (PPE). 6. Teaching activity: the participation of resident doctors as main surgeons or assistants is considered according to the procedure and the risk of the patient. In case they participate, personal protection precautions are maximized performed under adequate supervision. Prospective, descriptive study of the first patients operated after the implementation of measures included in the ''Protocol for surgical activity during the transition phase of the SARS-CoV-2 coronavirus pandemic'' of the Hospital Universitario 12 de Octubre. Several variables and indicators have been collected for the evaluation of the protocol, including demographic data, diagnostic and preoperative features and indicated procedure, results of clinical, epidemiological and analytical studies prior to surgery, postoperative complications, appearance of COVID-19 in the immediate postoperative period and evolution of these patients. Patient consent was requested for data collection and analysis, and it meets the requirements of the Ethics Committee for Research with medicinal products (ECRmp) of the Hospital Universitario 12 de Octubre. On May 4, 2020, elective surgery activity was restarted. By then, there were 43 patients on the priority 1 waitlist. Of them, 23 presented oncological pathologies. During the first 2 weeks we were provided with one operating room daily, since part of the surgical services was still dedicated to the care of patients with COVID-19. Twenty-three patients were evaluated; none of them had a history of COVID-19, suspicious symptoms, or had been in close contact with COVID-19 patients. Of these, 4 were not scheduled due to different reasons: one was treated at another hospital (radical prostatectomy), another for recent diagnosis of pulmonary embolism (laser adenomectomy), and another 2 were undergoing chemotherapy (adrenal tumor and bladder neoplasm). The 19 patients scheduled (all of them asymptomatic) underwent PCR for SARS-CoV-2 coronavirus and blood test according to protocol (Table 2) . Two patients were suspended, one for positive PCR (urethral tumor scheduled for urethrectomy), and the other (renal tumor scheduled for radical nephrectomy) for presenting abnormal laboratory findings (lymphopenia, increased CRP and coagulopathy). In the latter, despite the negative PCR for coronavirus, a chest X-ray was performed showing the presence of a middle-field infiltrate of the left lung suggestive of pneumonia, possibly related to COVID-19. Of the 17 patients who underwent surgery, 14 were diagnosed with neoplasms. Only 3 patients had a non-oncological diagnosis (a ureteral lithiasis, a penile prosthesis infection and one benign prostatic hyperplasia). During postoperative follow-up, with an interval of 4 to 14 days (median 10 days), no patients presented data on SARS-CoV-2 coronavirus infection. As relevant complications, we only found a surgical wound dehiscence in a penectomy. According to the epidemiological data, the deceleration phase of the COVID-19 pandemic began in mid-April. This translates into less human and material resources dedicated to this pandemic, which enables resumption of surgical activity, at least partially. To this end, we must guarantee patient and healthcare personnel safety, following the recommendations of the health care authorities and scientific societies, adopting the best practices available in our framework. 9,10 Based on these premises, we developed our care protocol, which highlights an adequate selection of patients (according to priority criteria), a prior rigorous study of their situation with respect to the COVID-19, and the establishment of pathways and procedures that guarantee, as far as possible, the safety of patients and professionals. We need an adequate prioritization of our patients, not only in terms of oncological or non-oncological pathologies, but also those with possible associated complications. 2, 7, 10, 11 We must consider that delaying surgery in oncological patients may imply a worse prognosis, but it may also increase complications in non-oncological patients. 3---5 In our case we have chosen to classify according to priorities, which includes not only tumoral pathology but also patients with potential complications with significant clinical impact and loss of quality of life. The response to surgical stress is associated with relevant changes in patient immunity. 12 These alterations require extreme precautions to be taken in surgical patients, taking into account that a 20% mortality rate has been reported in asymptomatic patients scheduled for surgery during the incubation period of COVID-19. 6 In addition, we must take into account that most of these patients present oncological pathologies, which seems to be associated with a greater vulnerability, among other infections, to the COVID-19. 13 This is why we determine the patient's COVID-19 status before surgery by means of a brief epidemiological survey; in case it is negative, we carry out the PCR for coronavirus SARS-CoV-2 as well as blood tests in search of alterations that suggest COVID-19. 14 Given the possibility of a false negative in the PCR for coronavirus, in case of suspicion due to abnormal laboratory test results, a chest CT scan would be indicated to rule out COVID-19. 15, 16 Systematic chest CT could be considered in all patients prior to surgery; however, we must take into account the capacity of each center in relation to the volume of surgeries performed. One of our first patients presented abnormal laboratory findings suggestive of COVID-19, with negative PCR for coronavirus. In this case, a chest CT scan was not performed, since the chest X-ray diagnosed pneumonia. Once the negativity of the patient for COVID-19 has been reasonably established, we must ensure the necessary conditions for a safe intervention and postoperative period. 9, 10 To this effect, we establish a negative COVID-19 circuit (F circuit), different from the one for patients diagnosed with COVID-19 and pending evaluation. It includes various inpatient units, operating rooms and resuscitation/ICU beds. Likewise, extreme measures must be taken to avoid contagion during admission, through hand hygiene, as well as with the use of disposable gloves, masks and gowns by hospital personnel. We must restrict visitors, use private rooms, and limit patient movement. In order to avoid patient isolation, we can provide a tablet to make video calls to family or friends, and prioritize quick recovery measures so that discharge is as early as possible. 10 The protection of healthcare personnel has to be a priority. In the specific case of operating rooms, the established measures recommend minimum personnel in the operating room, limited traffic, procedures performed by experienced surgeons, and reduced teaching work. 17, 18 The use of protective equipment in Urology stands on the performance of aerosol-generating procedures, as well as on the risk of splashing (risk of significant bleeding and contamination with gastrointestinal contents 19 ). Despite the fact that disease transmission through urine has not been demonstrated yet, the persistence of SARS-CoV-2 nucleic acid in urine has been reported, and preventive measures are advisable. 7 These measures include waterproof gown and shoe covers, face shields or goggles and type IIR (splash resistant) masks. The laparoscopic approach provides our patients with better recovery, but it could be associated with a higher risk of contagion through surgical smoke. We must keep pneumoperitoneum pressure as low as possible, and be careful to avoid leakage by using trocars of the smallest possible caliber or the use of suction before removing trocars and for specimen retrieval. 7, 17, 20, 21 Study limitations may include the fact that it is a small series regarding the number of patients, and the short follow-up (although all patients exceed the mean COVID-19 incubation period). However, we believe that the actions carried out for the development of this protocol, as well as the recommendations comprised in it, could be valuable to other groups who are currently designing their strategy to restart elective surgery. Compliance with these measures should be monitored continuously, as well as our patients' outcomes. The detection of cases of COVID-19 healthcare-associated infections would require an assessment of patient selection measures, preoperative evaluation and clearly, the functioning of the negative COVID-19 circuit. The progressive deceleration of the COVID-19 epidemic brings us to a new stage in which elective surgery activity must be restarted. It must be done in a way that the safety of our patients is guaranteed, without forgetting the safety of the health professionals. The protocolization of procedures provides us with quality care for our patients, minimizing the risk related to infection by the SARS-CoV-2 coronavirus. Preliminary results indicate that the protocol designed to ensure the correct implementation of preventive measures for the transmission of coronavirus infection is being safe and effective. This study has not received any funding. Fuente: Centro de Coordinación de Alertas y Emergencias Sanitarias Impacto de la pandemia COVID-19 en el servicio de urología de un centro de referencia en la Comunidad de Madrid Considerations in the triage of urologic surgeries during the COVID-19 Pandemic Risks from deferring treatment for genitourinary cancers: a collaborative review to aid triage and management during the COVID-19 Pandemic Urology practice during COVID-19 pandemic Clinical characteristics and outcomes of patients undergoing surgeries during the incubation period or COVID-19 infection European Association of Urology Guidelines Office Rapid Reaction Group: An Organisation-wide Collaborative Effort to Adapt the European Association of Urology Guidelines Recommendations to the Coronavirus Disease 2019 Era Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan China: a restrospective cohort study Recomendaciones técnicas para la gestión de la fase de transición de la pandemia de SARS-COV-2 (COVID-19) en el ámbito hospitalario. Grupo de Trabajo de la Asociación Madrileña de Calidad Asistencial (AMCA). 02/05/2020 Recomendaciones para la programación de cirugía en condiciones de seguridad durante el periodo de transición de la pandemia COVID-19. Ministerio de Sanidad (versión de 16 de mayo de 2020) COVID-19 and urology: a comprehensive review of the literature Perspectives on surgery in the time of COVID-19: safety first Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China The role of biomarkers in diagnosis of COVID-19 ---a systematic review False-negative or RT-PCR and prolonged nucleic acid conversion in COVID-19: rather than recurrence Diagnosis of the Coronavirus disease (COVID-19): rRT-PCR or CT? Manejo quirúrgico de pacientes con infección por COVID-19. Recomendaciones de la Asociación Española de Cirujanos COVID-19: Guide to Good Practice for Surgeons and Surgical Teams; 2020. Available from: www.rcseng.ac.uk/standardsandguidance Detection of SARS-CoV-2 in different types or clinical specimens Precautions for operating room team members during the COVID-19 pandemic Brief report. COVID-19: pandemic surgery guidance The authors of this study state that they have no conflicts of interest.