Background The COVID-19 pandemic has posed daunting challenges when conducting clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-Consent implementation in ongoing clinical trials are currently lacking. The NeuroSAFE PROOF trial is a randomized clinical trial evaluating the role of frozen section analysis during RARP for prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this paper is to describe the process of implementation, impact on recruitment rate, and patients’ experience using e-Consent. Methods A substantial amendment of the protocol granted the creation of a remote e-Consent framework based on the REDCap environment, following the structure and content of the already approved paper consent form. Although e-Consent obviated the need for in-person meeting, there was nonetheless counselling sessions performed interactively online. This new pathway offered continuous support to patients through remote consultations. The whole process was judged to be compliant with regulatory requirements before implementation. Results Before the first recruitment suspension, NeuroSAFE PROOF was recruiting an average of 9 patients per month. After e-Consent implementation, 63 new patients (4/month) have been enrolled despite a second lockdown, none of whom would have been recruited using the old methods given restrictions on face-to-face consultations. Patients have given positive feedback on the use of the platform. Limited troubleshooting has been required after implementation. Conclusion Remote e-Consent-based recruitment was critical for the continuation of the NeuroSAFE PROOF trial during the COVID-19 pandemic. The described pathway complies with ethical and regulatory guidelines for informed consent, while minimizing face-to-face interactions that increase the risk of COVID-19 transmission. This guide will help researchers integrate e-Consent to ongoing or planned clinical trials while uncertainty about the course of the pandemic continues. Trial registration NeuroSAFE PROOF trial NCT03317990. Registered on 23 October 2017. Regional Ethics Committee reference 17/LO/1978.

Background:The COVID-19 pandemic has posed daunting challenges for the conduction of clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-Consent implementation in ongoing clinical trials are currently lacking. The NeuroSAFE PROOF trial is a randomised clinical trial evaluating the role of frozen section analysis during RARP for prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this paper is to describe the process of implementation, impact on recruitment rate and patients’ experience using e-Consent.Methods:A substantial amendment of the protocol granted the creation of a remote e-Consent framework based on the REDCap environment, following the structure and content of the already approved paper consent form. A new pathway was developed which offered continuous support to patients through remote consultations. The whole process was judged to be compliant with regulatory requirements before implementation.Results:Before the first recruitment suspension, NeuroSAFE PROOF was recruiting an average of 9 patients per month. After e-Consent implementation, 63 new patients (4/month) have been enrolled despite a second lockdown, none of whom would have been recruited using the old methods given restrictions on face-to-face consultations. Patients have given positive feedback on the use of the platform. Limited troubleshooting has been required after implementation.Conclusion:Remote e-Consent based recruitment was critical for the continuation of the NeuroSAFE PROOF trial during the COVID-19 pandemic. The described pathway complies with ethical and regulatory guidelines for informed consent, while minimizing face-to-face interactions that increase the risk of COVID-19 transmission. This guide will help researchers integrate e-Consent to ongoing or planned clinical trials while uncertainty about the course of the pandemic continues.Trial registration: The NeuroSAFE PROOF trial has the registration number NCT03317990 (23 October 2017). Regional Ethics Committee; reference 17/LO/1978

Introducción: La prostatectomía radical asistida por robot (RARP) es  cada vez más utilizada alrededor del mundo. En México existen 13 hospitales que cuentan con equipo de cirugía robótica. En otros países ha demostrado disminuir la morbilidad quirúrgica con la misma efectividad en resultados oncológicos y funcionales. Objetivo: Reportar los resultados de experiencia inicial y seguimiento a corto plazo de RARP en el Centro Médico Naval. Material y métodos: Se realizó una revisión retrospectiva de los pacientes sometidos a RARP en nuestra unidad del 19 marzo 2016 al 30 abril 2018 que cumplieran con al menos 6 meses de seguimiento postquirúrgico. Resultados: Se realizaron 48 RARP, con una media de edad de 64,7 años, APE preoperatorio medio de 10,4ng/dl, con clasificación de riesgo bajo, intermedio y alto de 19, 29 y 52%. El tiempo quirúrgico medio fue de 240 minutos, sangrado medio 223 ml, 3 días de estancia hospitalaria. Se realizó neuropreservación al 56.3%, y se realizó linfadenectomía estándar a 68.8 y extendida a 31.2%. Tasa de bordes positivos del 45.8%. Se reportó falla bioquímica en el 14.6%. Un 12.5% recibieron radioterapia externa postquirúrgica. El tiempo medio de seguimiento fue de 9 meses. Documentamos una tasa de continencia completa en 91,3% de los pacientes y función eréctil suficiente para sexo en el 53,5% de los pacientes. Conclusiones: Reportamos resultados similares a los de la literatura mundial en morbilidad funcional y perioperatoria, en el inicio de nuestra curva de aprendizaje a pesar de tener una población con características de alto riesgo.

La actualización continua es parte esencial de la práctica médica. La cirugía asistida con robot es un procedimiento que se realiza desde 2001 y cada vez es más frecuente, debido a las ventajas que ofrece sobre la cirugía laparoscópica. Con el tiempo, su uso en el quirófano seguirá incrementándose, por lo que todo anestesiólogo debe estar familiarizado con el equipo y el procedimiento. En este artículo, se busca proporcionar la información necesaria para los anestesiólogos antes de que se enfrenten a una cirugía asistida con el Sistema Da Vinci ® , con un enfoque particular para la prostatectomía. Los retos para los que se debe estar preparado con este sistema incluyen: el espacio que ocupa el robot en el quirófano, la restricción en cuanto al acceso del paciente una vez colocado el carro de cirugía, la posición del paciente y el neumoperitoneo, incluyendo las consecuencias fisiológicas que esta combinación tendrá sobre el paciente. También, en el presente escrito, se revisan los distintos sistemas para cirugía robótica que existen, algunos de los procedimientos en los que se utilizan, las ventajas y desventajas, el procedimiento quirúrgico (prostatectomía asistida con robot) y el manejo anestésico, incluyendo los principales retos y algunas recomendaciones sobre el manejo transanestésico, los cuales serán de gran utilidad.

BackgroundRobotic radical prostatectomy (RARP) is a first-line curative treatment option for localized prostate cancer. Postoperative erectile dysfunction and urinary incontinence are common associated adverse side effects that can negatively impact patients’ quality of life. Preserving the lateral neurovascular bundles (NS) during RARP improves functional outcomes. However, selecting men for NS may be difficult when there is concern about incurring in positive surgical margin (PSM) which in turn risks adverse oncological outcomes. The NeuroSAFE technique (intra-operative frozen section examination of the neurovascular structure adjacent prostate margin) can provide real-time pathological consult to promote optimal NS while avoiding PSM.MethodsNeuroSAFE PROOF is a single-blinded, multi-centre, randomised controlled trial (RCT) in which men are randomly allocated 1:1 to either NeuroSAFE RARP or standard RARP. Men electing for RARP as primary treatment, who are continent and have good baseline erectile function (EF), defined by International Index of Erectile Function (IIEF-5) score>21, are eligible. NS in the intervention arm is guided by the NeuroSAFE technique. NS in the standard arm is based on standard of care, i.e., a pre-operative image-based planning meeting, patient-specific clinical information, and digital rectal examination. The primary outcome is assessment of EF at 12-months. The primary endpoint is the proportion of men who achieve IIEF-5 score ≥ 21. A sample size of 404 was calculated to give a power of 90% to detect a difference of 14% between groups based on a feasibility study. Oncological outcomes are continuously monitored by an independent Data Monitoring Committee. Key secondary outcomes include urinary continence at 3 months assessed by the international consultation on incontinence questionnaire, rate of biochemical recurrence, EF recovery at 24-months, and difference in quality of life.DiscussionThe NeuroSAFE PROOF is the first RCT of intra-operative frozen section in radical prostatectomy in the world. It is properly powered to evaluate a difference in the recovery of EF for men undergoing RARP assessed by patient reported outcome measures. It will provide evidence to guide the use of the NeuroSAFE technique around the world.Trial registration: NCT03317990 (23 October 2017). Regional Ethics Committee; reference 17/LO/1978.