Cost analysis of new robotic competitors: a comparison of direct costs for initial hospital stay between Da Vinci and Hugo RAS for radical prostatectomy.

Robotic surgery with Da Vinci has revolutionized the treatment of several diseases, including prostate cancer; nevertheless, costs remain the major drawback. Recently, new robotic platforms entered the market aiming to reduce costs and improve the access to robotic surgery. The aim of the study is to compare direct cost for initial hospital stay of radical prostatectomy performed with two different robotic systems, the Da Vinci and the new Hugo RAS system. This is a projection study that applies cost of robotic surgery, derived from a local tender, to the clinical course of robotic radical prostatectomy (RALP) performed with Da Vinci and Hugo RAS. The study was performed in a public referral center for robotic surgery equipped with both systems. The cost of robotic surgery from a local tender were considered and included rent, annual maintenance, and a per-procedure fee covering the setup of four robotic instruments. Those costs were applied to patients who underwent RALP with both systems since November 2022. The primary endpoint is to evaluate direct costs of initial hospital stay for Da Vinci and Hugo RAS, by considering equipment costs (as derived from the tender), and costs of theater and of hospitalization. The direct per-procedure cost is €2,246.31 for a Da Vinci procedure and €1995 for a Hugo RALP. In the local setting, Hugo RAS provides 11% of cost saving for RALP. By applying this per-procedure cost to our clinical data, the expenditure for the entire index hospitalization is € 6.7755,1 for Da Vinci and € 6.637,15 for Hugo RALP. The new Hugo RAS system is willing to reduce direct expenditures of robotic surgery for RALP; furthermore, it provides similar peri-operative outcomes compared to the Da Vinci. However, other drivers of costs should be taken into account, such as the duration of OR use-that is more than just console time and may depend on the facility's background and organization. Further variations in direct costs of robotic systems are related to caseload, local agreements and negotiations. Thus, cost comparison of new robotic platform still remains an ongoing issue.

Eficacia y seguridad del equipo sistema quirúrgico robótico, para el tratamiento de pacientes con cáncer de próstata no metastásico que requieran prostatectomía radical / Efficacy and safety of the prostatectomy surgical system team, for the treatment of patients with non-metastatic prostate cancer requiring radical prostatectomy

ANTECEDENTES: El presente documento de evaluación de tecnología sanitaria (ETS) expone el análisis de la eficacia y seguridad del equipo sistema quirúrgico robótica (SQR) en pacientes con cáncer de próstata (CaP) no metastásico sometidos a prostatectomía radical (PR). Mediante la NOTA N° 394-2023-GRPR y el INFORME TÉCNICO N° 385-SGPI-GPEIGCPP-ESSALUD-2022, el departamento de cirugía general y digestiva del Hospital Nacional Edgardo Rebagliati Martins (HNERM), a través de la Gerencia de la Red Prestacional Rebagliati, solicita al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la incorporación del SQR al petitorio de equipos biomédicos de EsSalud. El documento menciona que este equipo biornédico permitiría cumplir con los objetivos estratégicos del "Plan Estratégico Institucional 2020-2024" que busca "brindar a los asegurados acceso oportuno a prestaciones integrales y de calidad acorde a sus necesidades" y a la política de inversiones en EsSalud que busca "contribuir a mejorar la calidad de los servicios de salud". ASPECTOS GENERALES: La "cirugía robótica" o 'cirugía asistida por robot" es una técnica quirúrgica avanzada ,f-o que utiliza un sistema robótico controlado por un cirujano para realizar procedimientos p, uirúrgicos complejoc. Este sistema consta de una consola de control que el cirujano. utiliza para controlar los brazos robóticos del sistema equipados con instrumentos quirúrgicos miniaturizados que se introducen en el cuerpo del paciente a través de pequeñas incisiones (Diana & Marescaux, 2015). El cirujano controla los brazos mientras está sentado en una consola de computadora cerca de la mesa de operaciones que le brinda una vista ampliada de alta definición del sitio quirúrgico. Esta técnica permitiría realizar procedimientos mínimamente invasivos con mayor precisión, flexibilidad y control de lo que es posible con las técnicas convencionales (Bhandari, Zeffiro, & Reddiboina, 2020; Morrell et al., 2021). Existen varios sistemas de cirugía robótica en la actualidad que tienen sus propias características siendo importante emplear un sistema adecuado para determinados pacientes y procedimientos (Galfano et al., 2010; Morrell et al., 2021; Patel et al., 2011). Algunos de los más conocidos para cirugías abdominales y pélvicas son el da Vinci (Intuitive Surgical) o el Senhance (TransEnterix). Sin embargo, son dispositivos en constante evolución y que amplían progresivamente su oferta de aplicaciones. Siendo la prostatectomía radical uno de sus procedimientos más conocidos (Morrell et al., 2021). TECNOLOGÍA SANITARIA DE INTERÉS: Para realizar una cirugía robótica, el paciente se coloca en una mesa de operaciones y se administra anestesia general. Luego, se hacen pequeñas incisiones en el cuerpo del paciente y se insertan los instrumentos quirúrgicos y una cámara en el cuerpo a través de estos orificios. El cirujano se sienta en la consola de control y ve una imagen tridimensional en tiempo real de la parte del cuerpo del paciente en la que se está realizando la cirugía. Luego, utilizando los mandos y pedales de la consola, el cirujano controla los movimientos del brazo robótico y realiza los movimientos quirúrgicos necesarios (Diana & Marescaux, 2015; Galfano et al., 2010; Morrell et al., 2021). METODOLOGÍA: Se realizó una búsqueda sistemática de literatura científica a fin de identificar la mejor evidencia disponible a la fecha (hasta febrero del 2023) sobre la eficacia y seguridad del SQR. A partir de la pregunta PICO, se desarrolló una estrategia de búsqueda en 6 bases de datos (Medirle, Scopus, Embase, Scielo, Web of Science y Cochrane). En el ANEXO 2 se expone las bases de datos y la estrategia de búsqueda utilizada, así como el número de resultados obtenidos en cada una de estas. La búsqueda sistemática fue suplementada con una búsqueda manual en la lista de referencias bibliográficas de los estudios incluidos. Ademas, se realizó una búsqueda manual en los repositorios institucionales (Instituto Nacional de Enfermedades Neoplásicas (INEN), Unidad de Análisis y Generación de Evidencias en Salud Pública (UNAGESP), A.lational Institute for Heaith and Caro Exceilence (HICE), de la Canadian Agency for Drugs and Technologies iri Health (CADTH) y de la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA) y el buscador de Google (10 primeras páginas), a fin de poder identificar guías de práctica clínica (GPC) y ETS de relevancia que pudiesen haber sido omitidas por la estrategia de búsqueda o que no hayan sido publicadas en las bases de datos consideradas. Se consultaron páginas web de sociedades especializadas en urología y cirugía oncológica, como: European Association of Urology, American 'Jro!cgical Association y Confederación Americana de Urología. Por último, se realizó una búsqueda de estudios clínicos en ejecución o aún no terminados en las plataformas ClinicalTriais.gov e International Clinical Trial Registry Platform (ICTRP). RESULTADOS: Se identificaron 2659 documentos a partir de la búsqueda bibliográfica sistemática en bases de datos. Luego de eliminar duplicados, 1437 fueron elegibles para tamizaje por título y resumen con el aplicativo web Rayyan. Así, se obtuvieron 25 documentos elegibles para la evaluación a texto completo. Por otra parte, como producto de la búsqueda manual, se obtuvieron 12 documentos candidatos para revisión a texto completo. De esta manera, se revisaron 37 artículos a texto completo, de los cuales 20 fueron considerados elegibles para inclusión en esta ETS. Para mayor detalle, el flujo de selección de la evidencia se encuentra ilustrado a continuación. CONCLUSIONES: El presente dictamen expone una síntesis de la mejor evidencia disponible a la fecha sobre la eficacia y seguridad del sistema quirugico robotico - SQR en pacientes con cáncer de próstata - CaP no metastásico en comparación con las técnicas quirúrgicas convencionales disponibles en EsSalud (laparoscopia convencional o cirugía abierta). Los datos evaluados provenientes de ocho Evaluaciones Clinicas AleatorizadasECA para los pacientes con cáncer de próstata - CaP localizado, muestran mayor eficacia relacionado a desenlaces críticos como calidad de vida, continencia urinaria o potencia sexual, con un perfil similar de seguridad en relación con las complicaciones reportadas. El expediente del área usuaria menciona que el dispositivo tiene una vida útil de 8 años, pero no explicita garantías, costos de calibración, costos por repuestos o costos de mantenimiento en caso de avería lo cual debe ser precisado para realizar el análisis costo efectividad. En ese sentido el IETSI determina de manera preliminar que, en términos de eficacia y seguridad, se puede aprobar el uso del sistema quirúrgico robótico - SQR en pacientes con cáncer de próstata - CaP no metastásico que requieran prostatectomía radical - PR. Sin embargo, se debe realizar un análisis de costoefectividad adicional para contar con un adecuado balance de beneficios-daños y costos para la aprobación final de su uso. El equipo técnico evaluador del IETSI se mantiene a la expectativa de mayor evidencia confiable sobre la eficacia y seguridad del sistema quirúrgico robótico - SQR u otras nuevas tecnologías sanitarias propuestas, tomando de referencia la normativa vigente.

Eficacia y seguridad de la colocación de un sling masculino ajustable, en comparación con la colocación de un sling masculino fijo en pacientes con incontinencia urinaria de esfuerzo de intensidad leve a moderada post prostatectomía que han fallado al tratamiento conservador / Efficacy and safety of the placement of an adjustable male sling, compared with the placement of a fixed male sling in patients with post-prostatectomy mild to moderate stress urinary incontinence who have failed conservative treatment

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias (ETS), aprobada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021, se ha elaborado el presente dictamen, el cual expone la evaluación de la eficacia y seguridad de la colocación de un sling masculino (SM) transobturatriz ajustable con puerto de implantación subcutánea, en comparación con la colocación de un SM fijo, en pacientes varones con incontinencia urinaria (IU) de esfuerzo de intensidad leve a moderada, post prostatectomía y que han fallado al tratamiento conservador (ejercicios del piso pélvico). Mediante la Carta N° 056-DU-GQ-HNERM-GRPRESSALUD-2020, los médicos especialistas del servicio de urología general del Hospital Nacional Edgardo Rebagliati Martins (HNERM), a través de la gerencia de la Red Prestacional Rebagliati, solicitan al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la evaluación de la tecnología "Sistema Ajustable Transobturatriz masculino" para evaluar su posible inclusión al listado de material médico disponible en EsSalud para su utilización en el tratamiento de la incontinencia urinaria masculina por esfuerzo. ASPECTOS GENERALES: La IU es una complicación conocida del tratamiento de la próstata que impacta de manera negativa la calidad de vida (Miller et al., 2005). Esta condición predomina después de una prostatectomía radical (PR) debido a cáncer de próstata; pero también puede aparecer después de procedimientos por otras enfermedades prostáticas benignas. La IU después de un tratamiento prostático o IU post prostatectomía (IUPP), se debe principalmente a una función inadecuada del esfínter uretral. Esta deficiencia del esfínter se debe al efecto directo de la cirugía, con el daño al esfínter estriado externo durante la ligadura del complejo venoso dorsal, el daño al musculo liso de la uretra causado por las suturas de anastomosis, y/o denervación debido a la disección de la uretra y próstata. METODOLOGÍA: Se realizó una búsqueda sistemática de información con el objetivo de identificar la mejor evidencia disponible a la fecha sobre la eficacia y seguridad del sling masculino transobturatriz ajustable con puerto de implantación subcutánea. Se realizó una búsqueda bibliográfica avanzada en las bases de datos de PubMed, Cochrane Library y LILACS (Literatura Latinoamericana y del Caribe en Ciencias de la Salud). La búsqueda sistemática fue suplementada con una búsqueda manual en la lista de referencias bibliográficas de los estudios incluidos en la ETS. Además, se realizó una búsqueda de literatura gris en el motor de búsqueda Google, a fin de poder identificar otras publicaciones de relevancia que pudiesen haber sido omitidas por la estrategia de búsqueda o que no hayan sido publicadas en las bases de datos consideradas. Asimismo, se realizó una búsqueda dentro de las páginas web pertenecientes a grupos que realizan ETS y GPC, incluyendo, el National Institute for Health and Care Excellence (NICE), la Canadian Agency for Drugs and Technologies in Health (CADTH), la Haute Autorité de Santé (HAS), el Institut für Qualitát und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), además de la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA). Por último, se realizó una búsqueda de estudios clínicos en ejecución o aún no terminados en: ClinicalTrials.gov. RESULTADOS: No se identificaron estudios aleatorizados ni estudios observacionales con grupos de control para responder a la pregunta de interés. Para sintetizar mejor la evidencia y evaluar los aspectos de seguridad, se incluyeron un total de seis series de casos con al menos 50 participantes en cada estudio. Tres correspondieron al uso de sling masculino transobturatriz fijo (SMTF) y tres al ajustable. Además, inicialmente se incluyeron dos GPC del manejo de la incontinencia urinaria en el hombre. Sin embargo, durante la elaboración del presente dictamen, se publicó una versión actualizada (al 2022) de una de ellas, optando por su inclusión en el documento. CONCLUSIÓN: Por lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e Investigación aprueba el uso del sling masculino transobturatriz fijo en el tratamiento de la incontinencia urinaria de esfuerzo post prostatectomía de intensidad leve a moderada.

Single Port Robotic Surgery in Urology.

PURPOSE: To provide a comprehensive review on the new da Vinci SP (single port) robotic surgical system. The published literature to date within urology and a description of the new system will be discussed. FINDINGS: There are currently no high-quality published studies with the SP robotic system. All studies are case series, many with 10 or fewer patients. However, all studies have found the SP system to be safe and feasible in performing most urological procedures. Renal and pelvic surgery using the SP robotic system is safe and feasible in the hands of expert robotic surgeons. Long-term, high-quality data is lacking. While the current high price and the learning curve will limit the SP systems' use in many health care systems, new updates and the release of robotic surgical systems from other developers may help drive down costs and encourage uptake.

Learning From Those who Learned: A Survey of Fellowship Trained HoLEP Surgeons and Their Current Practice Patterns.

OBJECTIVE: To gain insight from the experience of learning Holmium laser enucleation of the prostate (HoLEP), teaching HoLEP, and the current HoLEP practice patterns of fellowship-trained endourologists. METHODS: Surveys were electronically distributed to United States (U.S.) practicing urologists who completed American Endourology fellowships (that included HoLEP) within the past 6 years. Questions focused on HoLEP training and current practice patterns. RESULTS: As of September 2019, 12% (6/49) of U.S. endourology fellowships reported including HoLEP as a component of training. With a 73% response rate (16 of 22), 81% participated in over 20 cases during training, while 50% participated in over 50. A total of 25% independently completed over 50 cases from start to finish. At training completion, most (80%) felt comfortable/somewhat comfortable completing an entire HoLEP independently and managing post-op complications. Seventy-five percent practice HoLEP currently, and 25% teach to trainees. When asked "What is most challenging about HoLEP in current practice?" common responses were: efficiency/profitability concerns, poor reimbursement, educating OR/hospital staff, establishing case volume, minimizing sphincter trauma, and large glands (>200gm). CONCLUSION: With diverse exposure in fellowship, most incorporate HoLEP into their practice after training. Aspects of the procedure remain challenging after several years of experience. Profitability/reimbursement concerns should be further explored to increase HoLEP adoption.

A prospective randomized controlled trial for assessment of perineal hydrodissection technique for nervesparing robot assisted radical prostatectomy.

BACKGROUND: This study prospectively evaluated the safety and efficacy of perineal hydrodissection in robot assisted nervesparing prostatectomy. METHODS: Patients were randomized for perineal, ultrasound guided hydrodissection (HD) before radical prostatectomy and compared with standard treatment (ST). Follow-up was done every 3 months, including erectile function (IIEF5-score), reported grade of erection, ability for sexual intercourse, continence, PSA. RESULTS: 21 patients were enrolled to this prospective study, 10 for ST and 11 for HD. No significant differences in demographic and preoperative oncological data between both groups were identified. Blood loss and time for surgery did not differ significantly. HD resulted in 66% (4/6) rate of positive surgical margins (PSM) in pT3 tumors vs 50% in ST (1/2; P = 0.67). Follow-up revealed higher IIEF scores, better ability for sexual intercourse and early continence in HD. CONCLUSIONS: Erectile function after radical prostatectomy was improved by perineal hydrodissection in this proof of principal study. However, careful patient selection and further studies are needed as perineal hydrodissection could result in increased positive surgical margins in pT3a tumors.

MRI assessment of tissue effects after 180-W XPS greenlight laser vaporization of the prostate.

BACKGROUND AND OBJECTIVE: Photoselective vaporization of the prostate (PVP) is an alternative to transurethral resection of the prostate (TURP) in the surgical management of Benign Prostate Obtruction (BPO), with a better hemostatic effect due to a coagulation depth of several millimeters. The objective of this study was to prospectively assess the tissue effects of PVP by Magnetic Resonance Imaging (MRI). MATERIALS AND METHODS: From December to February 2014, ten patients were included in a prospective study and underwent PVP performed by a single surgeon with the Greenlight™ laser 180-W XPS. A multiparametric MRI of the prostate (Siemens 3T Verio) was achieved the day before the procedure and post-operatively (2 days, 7 days, 3 and 6 months after the procedure). The prostate volume after tissue removal was determined. The depth of necrosis in the prostatic and peri-prostatic tissues were assessed at six different locations. RESULTS: The median age and pre-operative prostate volume were 70 years (64-76) and 48.1 ml (19-74.4), respectively. Median prostate volume significantly decreased post-operatively (P < 0.001): At 6 months, median prostate volume reduction was 44.2% (38.7-49.5) (P = 0.001) compared to pre-operative setting. Two and 7 days after the procedure, mean depths of necrosis were 2.5 mm (0-3) and 1.3 mm (0-2.4), respectively. No necrosis was reported 3 and 6 months after the procedure. CONCLUSIONS: PVP with Greenlight™ XPS 180-W is associated with a significant reduction of prostate volume. The depth of necrosis is low and homogeneous, resulting in a limited risk of peri-operative complications. Lasers Surg. Med. 49:577-581, 2017. © 2017 Wiley Periodicals, Inc.

A randomised controlled trial to determine the clinical and cost effectiveness of thulium laser transurethral vaporesection of the prostate (ThuVARP) versus transurethral resection of the prostate (TURP) in the National Health Service (NHS) - the UNBLOCS trial: a study protocol for a randomised controlled trial.

BACKGROUND: Transurethral resection of the prostate (TURP) has been the standard operation for benign prostatic obstruction (BPO) for 40 years, with approximately 25,000 procedures performed annually, and has remained largely unchanged. It is generally a successful operation, but has well-documented risks for the patient. Thulium laser transurethral vaporesection of the prostate (ThuVARP) vaporises and resects the prostate using a surgical technique similar to TURP. The small amount of study data currently available suggests that ThuVARP may have certain advantages over TURP, including reduced blood loss and shorter hospital stay, earlier return to normal activities, and shorter duration of catheterisation. DESIGN: A multicentre, pragmatic, randomised, controlled, parallel-group trial of ThuVARP versus standard TURP in men with BPO. Four hundred and ten men suitable for prostate surgery were randomised to receive either ThuVARP or TURP at four university teaching hospitals, and three district general hospitals. The key aim of the trial is to determine whether ThuVARP is equivalent to TURP judged on both the patient-reported International Prostate Symptom Score (IPSS) and the maximum urine flow rate (Qmax) at 12 months post-surgery. DISCUSSION: The general population has an increased life expectancy. As men get older their prostates enlarge, potentially causing BPO, which often requires surgery. Therefore, as the population ages, more prostate operations are needed to relieve obstruction. There is hence sustained interest in the condition and increasing need to find safer techniques than TURP. Various laser techniques have become available but none are widely used in the NHS because of lengthy training required for surgeons or inferior performance on clinical outcomes. Promising initial evidence from one RCT shows that ThuVARP has equivalent clinical effectiveness when compared to TURP, as well as other potential advantages. As ThuVARP uses a technique similar to that used in TURP, the learning curve is short, potentially making it also very quickly generalisable. This randomised study is designed to provide the high-quality evidence, in an NHS setting, with a range of patient-reported, clinical and cost-effectiveness outcomes, which will underpin and inform future NICE guidance. TRIAL REGISTRATION: ISRCTN registry, ISRCTN00788389 . Registered on 20 September 2013.

Therapeutic substitutions in the midst of new technology diffusion: The case of treatment for localized prostate cancer.

Robotic surgical systems have become increasingly popular worldwide. Robotic assisted radical prostatectomies have been widely adopted in the treatment of localized prostate cancer, replacing the conventional open surgeries. However, it is not clear whether this was achieved by substitution within the same treatment type (i.e., replacing open surgeries with robotic-assisted surgeries) or substitution across treatment types (i.e., expanding the proportion of patients receiving surgery while crowding out other forms of treatment for localized prostate cancer). Given the large number of patients undergoing these procedures each year, it is important to study the impact of the fast diffusion of robotic surgical systems on the overall treatment pattern of localized prostate cancer. We addressed this question using state-level cancer epidemiology data (256 observations) extracted from 2002 to 2010 National Cancer Database, and supply-side variables (e.g. density of robotic surgical systems, urologists) obtained from Area Resource File as well as investor presentations posted at the website of the manufacturer of robotic surgical systems. Recognizing that the purchase decision of robotic systems is potentially endogenous, we used an optimal instrumental variables panel estimation method to examine the impact while taking into account of the panel structure and the potential endogeneity of the density of robotic surgical systems and its quadratic term. We found that the density of robotic systems at state-level had a significantly positive impact on the rate of surgery and a significantly negative impact on the rate of radiation therapy. Further, our age-stratified analysis showed that the increase in surgery rate was most pronounced in the younger population. In conclusion, our findings suggest that part of the increase in the rate of surgery was driven by substitution across treatment types with a large proportion originating from the younger population.

Robotic Prostatectomy on the Web: A Cross-Sectional Qualitative Assessment.

BACKGROUND: Many patients diagnosed with prostate cancer search for information on robotic prostatectomy (RobP) on the Web. We aimed to evaluate the qualitative characteristics of the mostly frequented Web sites on RobP with a particular emphasis on provider-dependent issues. MATERIALS AND METHODS: Google was searched for the term "robotic prostatectomy" in Europe and North America. The mostly frequented Web sites were selected and classified as physician-provided and publically-provided. Quality was measured using Journal of the American Medical Association (JAMA) benchmark criteria, DISCERN score, and addressing of Trifecta surgical outcomes. Popularity was analyzed using Google PageRank and Alexa tool. Accessibility, usability, and reliability were investigated using the LIDA tool and readability was assessed using readability indices. RESULTS: Twenty-eight Web sites were physician-provided and 15 publically-provided. For all Web sites, 88% of JAMA benchmark criteria were fulfilled, DISCERN quality score was high, and 81% of Trifecta outcome measurements were addressed. Popularity was average according to Google PageRank (mean 2.9 ± 1.5) and Alexa Traffic Rank (median, 49,109; minimum, 7; maximum, 8,582,295). Accessibility (85 ± 7%), usability (92 ± 3%), and reliability scores (88 ± 8%) were moderate to high. Automated Readability Index was 7.2 ± 2.1 and Flesch-Kincaid Grade Level was 9 ± 2, rating the Web sites as difficult to read. Physician-provided Web sites had higher quality scores and lower readability compared with publically-provided Web sites. CONCLUSION: Websites providing information on RobP obtained medium to high ratings in all domains of quality in the current assessment. In contrast, readability needs to be significantly improved so that this content can become available for the populace.

Change of practice patterns in urology with the introduction of the Da Vinci surgical system: the Greek NHS experience in debt crisis era.

OBJECTIVE: To determine the attitudinal change for urologic surgery in Greece since the introduction of the da Vinci Surgical System (DVS). We describe contemporary trends at public hospital level, the initial Greek experience, while at the same time Greece is in economic crisis and funding is under austerity measures. MATERIALS AND METHODS: We retrospectively analyzed annualized case log data on urologic procedures, between 2008 (installation of the DVS) and 2013, from "Laiko'' Hospital in Athens. We evaluated, using summary statistics, trends and institutional status regarding robot-assisted surgery (RAS). We also analyzed the relationship between the introduction of RAS and change in total volume of procedures performed. RESULTS: 1578 of the urological procedures performed at "Laiko'' Hospital were pooled, 1342 (85%) being open and 236 RAS (15%). We observed a 6-fold increase in the number of RAS performed, from 7% of the total procedural volume (14/212) in 2008 to 30% (96/331) in 2013. For radical prostatectomy, in 2008 2% were robot-assisted and 98% open while in 2013, 46% and 54% respectively. Pyeloplasty was performed more often using the robot-assisted method since 2010. RAS-dedicated surgeons increased both RAS and the total number of procedures they performed. From 86 in 2008 to 145 in 2013, with 57% of them being RAS in 2013 as compared to 13 % in 2008. CONCLUSIONS: Robot-assisted surgery has integrated into the armamentarium for urologic surgery in Greece at public hospital level. Surgical robot acquisition is also associated with increased volume of procedures, especially prostatectomy, despite the ongoing debate over cost-effectiveness, during economic crisis and International Monetary Fund (IFN) era.

Reducing robotic prostatectomy costs by minimizing instrumentation.

INTRODUCTION AND OBJECTIVE: Since the introduction of robotic surgery for radical prostatectomy, the cost-benefit of this technology has been under scrutiny. While robotic surgery professes to offer multiple advantages, including reduced blood loss, reduced length of stay, and expedient recovery, the associated costs tend to be significantly higher, secondary to the fixed cost of the robot as well as the variable costs associated with instrumentation. This study provides a simple framework for the careful consideration of costs during the selection of equipment and materials. MATERIALS AND METHODS: Two experienced robotic surgeons at our institution as well as several at other institutions were queried about their preferred instrument usage for robot-assisted prostatectomy. Costs of instruments and materials were obtained and clustered by type and price. A minimal set of instruments was identified and compared against alternative instrumentation. A retrospective review of 125 patients who underwent robotically assisted laparoscopic prostatectomy for prostate cancer at our institution was performed to compare estimated blood loss (EBL), operative times, and intraoperative complications for both surgeons. Our surgeons now conceptualize instrument costs as proportional changes to the cost of the baseline minimal combination. RESULTS: Robotic costs at our institution were reduced by eliminating an energy source like the Ligasure or vessel sealer, exploiting instrument versatility, and utilizing inexpensive tools such as Hem-o-lok clips. Such modifications reduced surgeon 1's cost of instrumentation to ∼40% less compared with surgeon 2 and up to 32% less than instrumentation used by surgeons at other institutions. Surgeon 1's combination may not be optimal for all robotic surgeons; however, it establishes a minimally viable toolbox for our institution through a rudimentary cost analysis. A similar analysis may aid others in better conceptualizing long-term costs not as nominal, often unwieldy prices, but as percent changes in spending. With regard to intraoperative outcomes, the use of a minimally viable toolbox did not result in increased EBL, operative time, or intraoperative complications. CONCLUSION: Simple changes to surgeon preference and creative utilization of instruments can eliminate 40% of costs incurred on robotic instruments alone. Moreover, EBL, operative times, and intraoperative complications are not compromised as a result of cost reduction. Our process of identifying such improvements is straightforward and may be replicated by other robotic surgeons. Further prospective multicenter trials should be initiated to assess other methods of cost reduction.

Tissue quality assessment using a novel direct elasticity assessment device (the E-finger): a cadaveric study of prostatectomy dissection.

INTRODUCTION: Minimally invasive radical prostatectomy (RP) (robotic and laparoscopic), have brought improvements in the outcomes of RP due to improved views and increased degrees of freedom of surgical devices. Robotic and laparoscopic surgeries do not incorporate haptic feedback, which may result in complications secondary to inadequate tissue dissection (causing positive surgical margins, rhabdosphincter damage, etc). We developed a micro-engineered device (6 mm2 sized) [E-finger]) capable of quantitative elasticity assessment, with amplitude ratio, mean ratio and phase lag representing this. The aim was to assess the utility of the device in differentiating peri-prostatic tissue types in order to guide prostate dissection. MATERIAL AND METHODS: Two embalmed and 2 fresh frozen cadavers were used in the study. Baseline elasticity values were assessed in bladder, prostate and rhabdosphincter of pre-dissected embalmed cadavers using the micro-engineered device. A measurement grid was created to span from the bladder, across the prostate and onto the rhabdosphincter of fresh frozen cadavers to enable a systematic quantitative elasticity assessment of the entire area by 2 independent assessors. Tissue was sectioned along each row of elasticity measurement points, and stained with haematoxylin and eosin (H&E). Image analysis was performed with Image Pro Premier to determine the histology at each measurement point. RESULTS: Statistically significant differences in elasticity were identified between bladder, prostate and sphincter in both embalmed and fresh frozen cadavers (p = < 0.001). Intra-class correlation (ICC) reliability tests showed good reliability (average ICC = 0.851). Sensitivity and specificity for tissue identification was 77% and 70% respectively to a resolution of 6 mm2. CONCLUSIONS: This cadaveric study has evaluated the ability of our elasticity assessment device to differentiate bladder, prostate and rhabdosphincter to a resolution of 6 mm2. The results provide useful data for which to continue to examine the use of elasticity assessment devices for tissue quality assessment with the aim of giving haptic feedback to surgeons performing complex surgery.

[Robotic surgery -- the modern surgical treatment of prostate cancer]. / Robotsebészet, a prosztatarák modern sebészi kezelése.

Minimally invasive laparoscopic surgery replaces many open surgery procedures in urology due to its advantages concerning post-operative morbidity. However, the technical challenges and need of learning have limited the application of this method to the work of highly qualified surgeons. The introduction of da Vinci surgical system has offered important technical advantages compared to the laparoscopic surgical procedure. Robot-assisted radical prostatectomy became a largely accepted procedure. It has paved the way for urologists to start other, more complex operations, decreasing this way the operative morbidity. The purpose of this article is to overview the history of robotic surgery, its current and future states in the treatment of the cancer. We present our robot-assisted radical prostatectomy and the results.

Fabrication of novel bundled fiber and performance assessment for clinical applications.

BACKGROUND AND OBJECTIVES: During laser vaporization of benign prostate hyperplasia (BPH), high precision of optical fiber handling is pivotal to minimize any post-operative complications. The aim of the study was to evaluate the feasible applications of a bundled fiber to treat BPH by directionally and selectively manipulating laser light onto the targeted tissue. METHODS: A bundled optical fiber, consisting of four side-firing fibers, was fabricated to selectively emit laser beams in from one to four directions. Both transmission efficiency and light distribution were qualitatively and quantitatively characterized on the bundled fiber. In terms of interstitial application of the proposed fiber with 1064 nm on porcine liver tissue, the extent of thermal denaturation was estimated and compared at various laser parameterizations and for different directions of light. RESULTS: From the laser source to the fiber tip, the fabricated fiber device demonstrated a total light transmission of 52%. Due to internal light reflection, a secondary beam was emitted backward from the fiber tip and was responsible for 25% of the transmission loss. According to tissue testing, the extent of tissue denaturation generally increased with laser power, irradiation time, and number of light directions. The geometrical shape of thermal coagulation correlated well with the direction of light emission. Thermal damage to the glass tube occurred during excessive heat accumulation generated by continuous irradiation. CONCLUSIONS: The proposed fiber can be beneficial for laser vaporization of BPH by providing a selective light direction irradiation along with minimal thermal damage. Further studies will extend the applicability of the bundled fiber to treat tubular tissue structure.

A novel robotic system for single-port urologic surgery: first clinical investigation.

BACKGROUND: The idea of performing a laparoscopic procedure through a single abdominal incision was conceived with the aim of expediting postoperative recovery. OBJECTIVE: To determine the clinical feasibility and safety of single-port urologic procedures by using a novel robotic surgical system. DESIGN, SETTING, AND PARTICIPANTS: This was a prospective institutional review board-approved, Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) phase 1 study. After enrollment, patients underwent a major urologic robotic single-port procedure over a 3-wk period in July 2010. The patients were followed for 3 yr postoperatively. INTERVENTION: Different types of urologic surgeries were performed using the da Vinci SP Surgical System. This system is intended to provide the same core clinical capabilities as the existing multiport da Vinci system, except that three articulating endoscopic instruments and an articulating endoscopic camera are inserted into the patient through a single robotic port. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The main outcomes were the technical feasibility of the procedures (as measured by the rate of conversions) and the safety of the procedures (as measured by the incidence of perioperative complications). Secondary end points consisted of evaluating other key surgical perioperative outcomes as well as midterm functional and oncologic outcomes. RESULTS AND LIMITATIONS: A total of 19 patients were enrolled in the study. Eleven of them underwent radical prostatectomy; eight subjects underwent nephrectomy procedures (partial nephrectomy, four; radical nephrectomy, two; and simple nephrectomy, two). There were no conversions to alternative surgical approaches. Overall, two major (Clavien grade 3b) postoperative complications were observed in the radical prostatectomy group and none in the nephrectomy group. At 1-yr follow-up, one radical prostatectomy patient experienced biochemical recurrence, which was successfully treated with salvage radiation therapy. The median warm ischemia time for three of the partial nephrectomies was 38 min. At 3-yr follow-up all patients presented a preserved renal function; none had tumor recurrence. Study limitations include the small sample and the lack of a control group. CONCLUSIONS: We describe the first clinical application of a novel robotic platform specifically designed for single-port urologic surgery. Major urologic procedures were successfully completed without conversions. Further assessment is warranted to corroborate these promising findings. PATIENT SUMMARY: A novel purpose-built robotic system enables surgeons to perform safely and effectively a variety of major urologic procedures through a single small abdominal incision. TRIAL REGISTRATION: The study was registered on www.ClinicalTrials.gov (NCT02136121).

Using prediction intervals from random-effects meta-analyses in an economic model.

OBJECTIVES: When incorporating treatment effect estimates derived from a random-effect meta-analysis it is tempting to use the confidence bounds to determine the potential range of treatment effect. However, prediction intervals reflect the potential effect of a technology rather than the more narrowly defined average treatment effect. Using a case study of robot-assisted radical prostatectomy, this study investigates the impact on a cost-utility analysis of using clinical effectiveness derived from random-effects meta-analyses presented as confidence bounds and prediction intervals, respectively. METHODS: To determine the cost-utility of robot-assisted prostatectomy, an economic model was developed. The clinical effectiveness of robot-assisted surgery compared with open and conventional laparoscopic surgery was estimated using meta-analysis of peer-reviewed publications. Assuming treatment effect would vary across studies due to both sampling variability and differences between surgical teams, random-effects meta-analysis was used to pool effect estimates. RESULTS: Using the confidence bounds approach the mean and median ICER was €24,193 and €26,731/QALY (95%CI: €13,752 to €68,861/QALY), respectively. The prediction interval approach produced an equivalent mean and median ICER of €26,920 and €26,643/QALY (95%CI: -€135,244 to €239,166/QALY), respectively. Using prediction intervals, there is a probability of 0.042 that robot-assisted surgery will result in a net reduction in QALYs. CONCLUSIONS: Using prediction intervals rather than confidence bounds does not affect the point estimate of the treatment effect. In meta-analyses with significant heterogeneity, the use of prediction intervals will produce wider ranges of treatment effect, and hence result in greater uncertainty, but a better reflection of the effect of the technology.

Modifiable factors to decrease the cost of robotic-assisted procedures.

In 2000, the US Food and Drug Administration approved the da Vinci Surgical System® for use in the United States. Since that time, the number of surgical robotic systems throughout the United States has continued to grow. The costs for using the system include the initial purchase ($1 million to $2.3 million) plus annual maintenance fees ($100,000 to $150,000) and the cost of limited-use or disposable instruments. Increasing the number of procedures that are performed using the robotic system can decrease the per-procedure costs. Two modifiable factors that contribute to increasing the annual caseload are increasing the number of surgeons capable of using the system and having a properly educated perioperative nursing team. An educated surgical team decreases turnover time, facilitates proper flow of each surgical procedure, and is able to actively and passively solve intraoperative problems.

Laparoscopic prostatectomy for prostate cancer: continued role in urology.

The purpose of this article is to provide an update on the current literature evaluating outcomes with laparoscopic prostatectomy. The reported perioperative, oncologic, and functional outcomes with this approach are reviewed and comparisons are made to the open and robotic-assisted approaches.