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1.
Int J Clin Oncol ; 29(6): 640-646, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38625439

ABSTRACT

In the field of urology, robotic surgery has gained rapid and wide acceptance as a standard surgical approach in the majority of major surgeries over the last decade. To date, the da Vinci surgical system has been the dominant platform in robotic surgery; however, several newly developed robotic systems have recently been introduced in routine clinical practice. Of these, hinotori, the first made-in-Japan robotic system, is characterized by various unique and attractive features different from the existing system, and the use of this system has gradually increased mainly in urologic cancer surgeries, including radical prostatectomy, partial nephrectomy, radical nephrectomy, and radical nephroureterectomy. This review initially describes detailed characteristics of hinotori, then summarizes the early experience with urologic cancer surgeries using hinotori at our institution, and finally discusses the future prospects of robotic surgery using hinotori, considering problems associated with the use of this robotic system.


Subject(s)
Prostatectomy , Robotic Surgical Procedures , Urologic Neoplasms , Humans , Robotic Surgical Procedures/methods , Robotic Surgical Procedures/instrumentation , Urologic Neoplasms/surgery , Prostatectomy/methods , Prostatectomy/instrumentation , Nephrectomy/methods , Nephrectomy/instrumentation , Urologic Surgical Procedures/instrumentation , Urologic Surgical Procedures/methods , Nephroureterectomy/methods , Male
2.
Aktuelle Urol ; 55(3): 236-242, 2024 Jun.
Article in German | MEDLINE | ID: mdl-38604230

ABSTRACT

The Holmium:YAG laser has been the gold standard for laser lithotripsy over the past three decades and, since the late 1990s, also for prostate enucleation. Pulsed thulium fibre lasers (TFL) demonstrated their efficacy in in-vitro experiments and were introduced to the market a few years ago. Initial clinical results for TFL in lithotripsy and enucleation are very promising. In addition to TFL, a pulsed Thulium:YAG solid-state laser has been introduced, but clinical data for this laser are currently limited. This article aims to review the key technological differences between Ho:YAG lasers and pulsed thulium lasers and compare/discuss the initial clinical results for stone lithotripsy and laser enucleation.In-vitro studies have demonstrated the technical superiority of TFL compared with Ho:YAG lasers. However, as TFL is still a new technology, only limited studies are available to date, and optimal settings for lithotripsy have not been established. For enucleation, the differences of TFL compared with a high-power Ho:YAG laser seem to be clinically irrelevant. Initial studies on pulsed Tm:YAG lasers show good results, but there continues to be a lack of comparative studies.Based on the current literature, pulsed thulium lasers have the potential of being an alternative to Ho:YAG lasers. However, further studies are necessary to determine the optimal laser technology for enucleation and lithotripsy of urinary stones, considering all parameters, including efficacy, safety, and cost.


Subject(s)
Lasers, Solid-State , Lithotripsy, Laser , Thulium , Humans , Male , Lasers, Solid-State/therapeutic use , Lithotripsy, Laser/methods , Lithotripsy, Laser/instrumentation , Prostatectomy/instrumentation , Prostatectomy/methods
3.
Lima; IETSI; mar. 2024.
Non-conventional in Spanish | BRISA/RedTESA | ID: biblio-1553250

ABSTRACT

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.


Subject(s)
Humans , Prostatectomy/instrumentation , Prostatic Neoplasms/surgery , Robotic Surgical Procedures/instrumentation , Efficacy , Cost-Benefit Analysis/economics
4.
Lima; IETSI; ago. 2022.
Non-conventional in Spanish | BRISA/RedTESA | ID: biblio-1551828

ABSTRACT

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.


Subject(s)
Humans , Prostatectomy/instrumentation , Urinary Incontinence, Stress/therapy , Suburethral Slings , Conservative Treatment/adverse effects , Efficacy , Cost-Benefit Analysis
5.
Urology ; 161: 100-104, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34968568

ABSTRACT

OBJECTIVE: To determine the incidence and predictive factors for conversion to an open procedure during Holmium Laser Enucleation of Prostate (HoLEP). METHODS: A retrospective review was performed on files of all patients that underwent HoLEP at our institution between 2013 and 2020. Data collected included demographics, pre-operative estimated prostate size, intraoperative data, pathologic data, and functional baseline. A univariate and multivariate comparison between the pre-operative data of converted and un-converted cases was conducted. RESULTS: Among a total of 807 HoLEP procedure performed during the above period, 20 cases were converted to open procedures (2.4%). Median pre-operative estimated prostate size in cases of conversion was 228ml compared to 95ml for unconverted cases (P <.001). The reasons for conversion were anatomical in 8 cases (40%), bleeding that was difficult to control endoscopically in 4 cases (20%), expected procedure to be too long due to large prostate size in 6 cases (30%), one case of morcellation technical malfunction, and one case with very large bladder stones not suitable for endoscopic treatment. Prostate size was the only factor that was found to be associated with conversion in univariate and multivariate analysis. CONCLUSION: The risk of conversion of HoLEP to open procedures is size-dependent. The risk for conversion to open prostatectomy/cystotomy must be communicated to patients who choose HoLEP to improve the informed consent process and provide the highest quality of patient care and transparency. Open prostatectomy/cystotomy should be a part of the armamentarium of every HoLEP surgeon operating on large prostates.


Subject(s)
Laser Therapy/methods , Lasers, Solid-State/therapeutic use , Prostatectomy/methods , Prostatic Hyperplasia/surgery , Transurethral Resection of Prostate/methods , Holmium/chemistry , Humans , Laser Therapy/instrumentation , Male , Prostate/pathology , Prostate/surgery , Prostatectomy/instrumentation , Prostatic Hyperplasia/complications , Transurethral Resection of Prostate/instrumentation , Treatment Outcome
7.
Investig Clin Urol ; 62(6): 666-671, 2021 11.
Article in English | MEDLINE | ID: mdl-34729966

ABSTRACT

PURPOSE: Previously published studies have shown small prostate size, capsular perforation and intraoperative bladder distension are associated with failed trial without a catheter (TWOC) after HoLEP. The study objective was to determine the relationship between MOSES pulse modulation versus standard laser technology and short-term catheter reinsertion following failed TWOC. MATERIALS AND METHODS: The study included 487 patients who underwent HoLEP, using standard holmium laser settings (180 patients) or MOSES pulse modulation (255 patients), between August 2018 and February 2021. Catheter reinsertion defined as reinsertion following failed TWOC within 30 days of surgery. Association of pulse modulation with catheter reinsertion was examined using single and multivariable logistic regression models. Comparisons of pre and intraoperative characteristics between patients treated without and with pulse modulation were made using a Wilcoxon rank sum test for numeric characteristics or Fisher's exact test for categorical characteristics. RESULTS: Short-term catheter reinsertion occurred in 14% (26/180) of the standard laser setting group as compared with 10% (24/252) of the pulse modulation group. There was no statistically significant association with short-term catheter reinsertion in single (unadjusted OR [standard settings vs. pulse modulation], 1.60; 95% CI, 0.80-2.91; p=0.12) or multivariable analysis adjusting for specimen weight and operative time (adjusted OR [standard settings vs. pulse modulation], 1.44; 95% CI, 0.77-2.68; p=0.25). CONCLUSIONS: In this study, we found no association between post-HoLEP short-term catheter reinsertion following failed TWOC and MOSES pulse modulation. Although MOSES pulse modulation offers several well-documented advantages, catheter reinsertion events appear to be attributable to other factors.


Subject(s)
Laser Therapy , Postoperative Complications , Prostatectomy , Prostatic Hyperplasia/surgery , Retreatment , Urinary Catheterization , Aged , Comparative Effectiveness Research , Holmium/therapeutic use , Humans , Laser Therapy/adverse effects , Laser Therapy/methods , Male , Outcome Assessment, Health Care/methods , Outcome Assessment, Health Care/statistics & numerical data , Postoperative Complications/etiology , Postoperative Complications/therapy , Prostate/pathology , Prostate/surgery , Prostatectomy/adverse effects , Prostatectomy/instrumentation , Prostatectomy/methods , Retreatment/methods , Retreatment/statistics & numerical data , Urinary Catheterization/methods , Urinary Catheterization/statistics & numerical data , Urinary Catheters
8.
Eur Rev Med Pharmacol Sci ; 25(13): 4527-4534, 2021 Jul.
Article in English | MEDLINE | ID: mdl-34286495

ABSTRACT

OBJECTIVE: Aim of the study was to evaluate efficacy and efficiency of 180-watt Green-Light XPS (GL-XPS) laser photoselective vaporization of the prostate (PVP) in patients under 5-Alpha-Reductase Inhibitors (5ARI) treatment. PATIENTS AND METHODS: A consecutive series of patients with lower urinary tract symptoms due to benign prostatic enlargement treated by PVP with the GL-XPS were enrolled. Patients were divided in two groups according to the chronic use (>6 months) of 5ARI. These two groups were compared on lasing density (kilojoules per prostate volume), vaporization efficiency (prostate volume per lasing time), vaporization power (kilojoules per lasing time), Prostate Specific Antigen (PSA) reduction from baseline, symptom score change from baseline and uroflowmetry parameters improvement. Follow-up was performed at 3, 6 and 12 months with International Prostate Symptom Score, Uroflowmetry parameters and PSA. RESULTS: Overall 193 patients were enrolled. Out of them 87/193 (45%) were on 5ARI treatment. No significant differences were recorded between the two groups at baseline. Median age was 68 years old and median prostate volume was 60 ml. In terms of laser efficiency, no statistically significant differences were recorded in terms of lasing time (25 min vs. 24.5 min; p>0.05); energy used (250 kJ vs. 221 kJ; p>0.05), lasing density (6.8 kJ/ml vs. 6.6 kJ/ml, p>0.05), vaporization efficiency (1.4 ml/min vs. 1.3 ml/min, p>0.05) and vaporization power (9.6 kJ/min vs. 9.4 kJ/min; p>0.05). Finally, no significant differences were also recorded postoperatively in the two groups in terms of PSA reduction, improvement in symptom score and uroflowmetry parameters (p>0.05). CONCLUSIONS: Thirty-seven efficacy and efficiency outcomes were not statistically different between the two groups. 5ARI does not reduce the performance and ability of the 180-watt Green-Light XPS laser system.


Subject(s)
5-alpha Reductase Inhibitors/administration & dosage , Laser Therapy/instrumentation , Prostate/pathology , Prostatectomy/instrumentation , Prostatic Hyperplasia/therapy , Aged , Combined Modality Therapy/instrumentation , Combined Modality Therapy/methods , Follow-Up Studies , Humans , Laser Therapy/adverse effects , Male , Middle Aged , Organ Size/drug effects , Organ Size/radiation effects , Prostate/drug effects , Prostate/radiation effects , Prostatectomy/adverse effects , Prostatectomy/methods , Prostatic Hyperplasia/diagnosis , Prostatic Hyperplasia/pathology , Treatment Outcome
9.
Asian J Androl ; 23(6): 640-647, 2021.
Article in English | MEDLINE | ID: mdl-34135173

ABSTRACT

To evaluate outcomes between extraperitoneal robotic single-port radical prostatectomy (epR-spRP) and extraperitoneal robotic multiport radical prostatectomy (epR-mpRP) performed with the da Vinci Si Surgical System, comparison was performed between 30 single-port (SP group) and 26 multiport (MP group) cases. Comparisons included operative time, estimated blood loss (EBL), hospital stay, peritoneal violation, pain scores, scar satisfaction, continence, and erectile function. The median operation time and EBL were not different between the two groups. In the SP group, the median operation time of the first 10 patients was obviously longer than that of the latter 20 patients (P < 0.001). The median postoperative hospital stay in the SP group was shorter than that in the MP group (P < 0.001). The rate of peritoneal damage in the SP group was less than that in the MP group (P = 0.017). The pain score and overall need for pain medications in the SP group were lower than those in the MP group (P < 0.001 and P = 0.015, respectively). Patients in the SP group were more satisfied with their scars than those in the MP group 3 months postoperatively (P = 0.007). At 3 months, the cancer control, recovery of erectile function, and urinary continence rates were similar between the two groups. It is safe and feasible to perform epR-spRP using the da Vinci Si surgical system. Therefore, epR-spRP can be a treatment option for localized prostate cancer. Although epR-spRP still has a learning curve, it has advantages for postoperative pain and self-assessed cosmesis. In the absence of the single-port robotic surgery platform, we can still provide minimally invasive surgery for patients.


Subject(s)
Outcome Assessment, Health Care/statistics & numerical data , Perioperative Medicine/instrumentation , Prostatectomy/instrumentation , Robotic Surgical Procedures/standards , Aged , Blood Loss, Surgical/statistics & numerical data , Humans , Male , Middle Aged , Outcome Assessment, Health Care/methods , Perioperative Medicine/standards , Perioperative Medicine/statistics & numerical data , Prostatectomy/methods , Prostatic Neoplasms/surgery , Quality Assurance, Health Care/statistics & numerical data , Robotic Surgical Procedures/methods , Robotic Surgical Procedures/statistics & numerical data
10.
PLoS One ; 16(6): e0253081, 2021.
Article in English | MEDLINE | ID: mdl-34138904

ABSTRACT

BACKGROUND AND OBJECTIVE: Few studies have investigated the association between surgical volume and outcome of robot-assisted radical prostatectomy (RARP) in an unselected cohort. We sought to investigate the association between surgical volume with peri-operative and short-term outcomes in a nation-wide, population-based study group. METHODS: 9,810 RARP's registered in the National Prostate Cancer Register of Sweden (2015-2018) were included. Associations between outcome and volume were analyzed with multivariable logistic regression including age, PSA-density, number of positive biopsy cores, cT stage, Gleason score, and extent of lymph node dissection. RESULTS: Surgeons and hospitals in the highest volume group compared to lowest group had shorter operative time; surgeon (OR 9.20, 95% CI 7.11-11.91), hospital (OR 2.16, 95% CI 1.53-3.06), less blood loss; surgeon (OR 2.58. 95% CI 2.07-3.21) hospital (no difference), more often nerve sparing intention; surgeon (OR 2.89, 95% CI 2.34-3.57), hospital (OR 2.02, 95% CI 1.66-2.44), negative margins; surgeon (OR 1.90, 95% CI 1.54-2.35), hospital (OR 1.28, 95% CI 1.07-1.53). There was wide range in outcome between hospitals and surgeons with similar volume that remained after adjustment. CONCLUSIONS: High surgeon and hospital volume were associated with better outcomes. The range in outcome was wide in all volume groups, which indicates that factors besides volume are of importance. Registration of surgical performance is essential for quality control and improvement.


Subject(s)
Prostatectomy/instrumentation , Prostatic Neoplasms/surgery , Robotic Surgical Procedures/methods , Aged , Hospitals, High-Volume , Hospitals, Low-Volume , Humans , Lymph Node Excision , Male , Margins of Excision , Middle Aged , Neoplasm Grading , Operative Time , Perioperative Period , Prostatic Neoplasms/pathology , Surgeons , Sweden , Treatment Outcome
11.
Urology ; 156: 211-215, 2021 10.
Article in English | MEDLINE | ID: mdl-33971189

ABSTRACT

OBJECTIVE: To examine voluntary reports in the Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, categorize complications and assign device-related causality with transurethral resection of the prostate (TURP), prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT). METHODS: A review was performed using the terms "Urolift," "Rezum," and "transurethral resection of the prostate" between 01/01/2015 and 12/31/2019. Duplicate and incomplete reports were excluded. The Gupta system was used to report complications and device related causality.1 Pearson's Chi-square analysis was performed to compare minor (Level 1) versus major (Levels 2-4) complications. RESULTS: A total of 548 events were examined. After removal of duplicates (n = 60), irrelevant reports (n=65), and incomplete information (n = 14), we included 409 events (74.6%). Of the 409 events, 214 were for TURP, 112 for TWVT, and 83 for PUL. In aggregate, 39.4% of events were minor/Level 1 (n=161/409). The proportion of subjects with Level 2-4 complications versus Level 1 complications was significantly higher for PUL than TURP or TWVT [X2 (2, N = 408) = 41.4023, P < .00001]. Device causality was attributable to device malfunction in 60.4% of cases (n=247/409). CONCLUSION: Device malfunction was noted in all groups and 39.4% of these were minor (Level 1). However, the majority of PUL reports noted a Level 3 or 4 complication (50.6%, 42/83), primarily bleeding related. Previous studies have not revealed significant risk of bleeding and suggests a discrepancy between study data and real-world experience that may alter patient counseling practices.


Subject(s)
Databases, Factual , Equipment Failure/statistics & numerical data , Postoperative Complications/etiology , Product Surveillance, Postmarketing , Prostatectomy/adverse effects , Prostatectomy/instrumentation , Prostatic Hyperplasia/surgery , United States Food and Drug Administration , Urinary Bladder Neck Obstruction/surgery , Humans , Male , Prostatic Hyperplasia/complications , Severity of Illness Index , United States , Urinary Bladder Neck Obstruction/etiology
12.
Curr Urol Rep ; 22(4): 22, 2021 Feb 08.
Article in English | MEDLINE | ID: mdl-33554322

ABSTRACT

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.


Subject(s)
Robotic Surgical Procedures/instrumentation , Urologic Diseases/surgery , Urologic Surgical Procedures/instrumentation , Cystectomy/instrumentation , Cystectomy/methods , Endoscopy , Humans , Imaging, Three-Dimensional , Kidney Pelvis/surgery , Learning Curve , Nephrectomy/instrumentation , Nephrectomy/methods , Prostatectomy/instrumentation , Prostatectomy/methods , Plastic Surgery Procedures/instrumentation , Plastic Surgery Procedures/methods , Robotic Surgical Procedures/economics , Robotic Surgical Procedures/education , Robotic Surgical Procedures/trends , Ureter/surgery , Urinary Bladder/surgery , Urologic Surgical Procedures/economics , Urologic Surgical Procedures/education , Urologic Surgical Procedures/trends
13.
World J Urol ; 39(8): 3019-3024, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33392647

ABSTRACT

PURPOSE: Aquablation using the AquaBeam system combines real-time image guidance and robotics to enable precise and heat-free removal of prostatic tissue with a high velocity water jet. The aim of this study is to report the outcomes of Aquablation up to 1 year in a single centre within the UK employing an athermal approach to haemostasis. METHODS: Fifty-five consecutive men underwent Aquablation between September 2017 and December 2018 (as part of OPEN WATER trial). Standard Aquablation was performed with the AquaBeam system (PROCEPT® BioRobotics) with 2 passes of Aquablation followed by bladder washout with application of continuous bladder irrigation via a catheter on a continuous traction device. Patients were followed up at 3 and 12 months. The data were prospectively collected on patient demographics, uroflowmetry, prostate volume, International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) and International Index of Erectile Function (IIEF-15). RESULTS: The mean age was 64.1 ± 7.9 years. Operating time was 26.9 ± 9.2 min. Mean prostate volume decreased from 58.2 ± 23.9 cc to 33.2 ± 12.9 cc (p < 0.0001). There were significant improvements at the 12 month follow-up in maximum urinary flow rate (9.9 ± 5.1 ml/s vs. 23.9 ± 11.6 ml/s), IPSS (21.7 ± 7.4 vs. 6.1 ± 4.2) and quality of life score (4.8 ± 1.1 vs. 1.4 ± 1.4) (p < 0.0001). There was no significant change in IIEF-15 and MSHQ-EjD scores. There were 8 (14.5%) Clavien grade 2 or higher complications. CONCLUSION: Our single centre experience suggests Aquablation using an entirely athermal approach is a safe cavitating procedure resulting in significant LUTS improvement comparable to standard cavitating procedures with greater preservation of sexual function.


Subject(s)
Postoperative Complications , Prostate , Prostatectomy , Prostatic Hyperplasia , Quality of Life , Robotic Surgical Procedures , Sexual Dysfunction, Physiological , Ablation Techniques/instrumentation , Ablation Techniques/methods , Follow-Up Studies , Hemostatic Techniques/instrumentation , Humans , Male , Middle Aged , Operative Time , Organ Size , Postoperative Complications/diagnosis , Postoperative Complications/prevention & control , Postoperative Complications/psychology , Prostate/diagnostic imaging , Prostate/pathology , Prostatectomy/adverse effects , Prostatectomy/instrumentation , Prostatectomy/methods , Prostatic Hyperplasia/epidemiology , Prostatic Hyperplasia/pathology , Prostatic Hyperplasia/surgery , Robotic Surgical Procedures/instrumentation , Robotic Surgical Procedures/methods , Sexual Dysfunction, Physiological/diagnosis , Sexual Dysfunction, Physiological/etiology , Sexual Dysfunction, Physiological/prevention & control , Surgery, Computer-Assisted/instrumentation , Surgery, Computer-Assisted/methods , Treatment Outcome , United Kingdom/epidemiology
14.
World J Urol ; 39(8): 3025-3033, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33388914

ABSTRACT

PURPOSE: To describe the novel technique of photoselective sharp enucleation of the prostate (PSEP) with a front-firing 532-nm laser and evaluate its efficacy and safety. METHODS: A seven-step standardized surgical procedure was established, and PSEP was performed in an en bloc or lobulate manner according to the size of the middle lobe of the prostate. The following clinical data of 583 patients who underwent PSEP in our center from November 2016 to May 2018 were retrospectively reviewed: maximum flow rate (Qmax), International Prostate Symptom Score (IPSS), quality of life score (Qols), post-void residual volume (PVR), prostate volume, operation time, serum prostate-specific antigen (PSA) concentration, and complications at 1, 6, and 12 months postoperatively. RESULTS: Of the 583 patients, 475 had complete clinical information and were included in the study. The median operation time was 39 min. There were significant improvements in the Qmax, IPSS, Qols, PVR and PSA concentration at each follow-up time point postoperatively. Postoperative hemorrhage occurred in 22 patients (4.6%), urinary retention in 29 (6.1%), urinary tract infection in 55 (11.6%), bladder neck contracture in 8 (1.7%), urethral strictures in 11 (2.3%), and stress urinary incontinence in 9 (1.9%). CONCLUSIONS: PSEP is effective and safe for the treatment of benign prostatic hyperplasia. The innovative technique integrates the excellent hemostatic property of the 532-nm laser and the high efficiency of enucleation. It decreases the occurrence of postoperative incontinence associated with "blunt" enucleation of 532-nm laser and eliminates the lack of tissue samples problem associated with photoselective vaporization of the prostate.


Subject(s)
Laser Therapy , Lasers, Solid-State , Postoperative Complications , Prostate , Prostatectomy , Prostatic Hyperplasia , Quality of Life , Urinary Incontinence , China/epidemiology , Hemostatic Techniques , Humans , Laser Therapy/adverse effects , Laser Therapy/instrumentation , Laser Therapy/methods , Male , Middle Aged , Organ Size , Postoperative Complications/diagnosis , Postoperative Complications/prevention & control , Postoperative Complications/psychology , Prostate/diagnostic imaging , Prostate/pathology , Prostatectomy/adverse effects , Prostatectomy/instrumentation , Prostatectomy/methods , Prostatic Hyperplasia/epidemiology , Prostatic Hyperplasia/pathology , Prostatic Hyperplasia/surgery , Treatment Outcome , United Kingdom/epidemiology , Urinary Incontinence/diagnosis , Urinary Incontinence/etiology , Urinary Incontinence/prevention & control
15.
Urology ; 149: 193-198, 2021 03.
Article in English | MEDLINE | ID: mdl-33412221

ABSTRACT

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.


Subject(s)
Endoscopy/education , Laser Therapy/methods , Practice Patterns, Physicians'/statistics & numerical data , Prostatectomy/education , Prostatic Hyperplasia/surgery , Endoscopy/instrumentation , Endoscopy/methods , Endoscopy/statistics & numerical data , Fellowships and Scholarships/methods , Fellowships and Scholarships/statistics & numerical data , Humans , Laser Therapy/instrumentation , Laser Therapy/statistics & numerical data , Lasers, Solid-State/therapeutic use , Male , Prostatectomy/instrumentation , Prostatectomy/methods , Prostatectomy/statistics & numerical data , Surgeons/education , Surgeons/statistics & numerical data , Surveys and Questionnaires/statistics & numerical data , Teaching/statistics & numerical data , Urologists/education , Urologists/statistics & numerical data , Workload/statistics & numerical data
16.
Urology ; 149: 187-192, 2021 03.
Article in English | MEDLINE | ID: mdl-33412223

ABSTRACT

OBJECTIVE: To determine if MOSES technology improves efficiency and short-term outcomes in holmium laser ablation of the prostate (HoLAP). METHODS: A retrospective review of patients who underwent HoLAP between August 2016 and November 2019 was conducted. All procedures before and after the implementation of MOSES technology at our institution were evaluated. Preoperative patient characteristics and intraoperative data were collected. Postoperative International Prostate Symptom Score, quality of life, and postvoid residual measurements at 6 weeks and 3 months postoperatively were analyzed. RESULTS: This cohort included 65 males who underwent HoLAP, 32 without and 33 with MOSES. Patients in the MOSES group were slightly older, but no other differences in baseline characteristics were observed between the two groups. Ablation time was similar at 49.6 ± 26.1 minutes without and 40.7 ± 41.2 minutes with MOSES (P = .38). However, HoLAP with MOSES had significantly higher ablation efficiency (0.59 ± 0.24 g/min without vs 0.86 0.5 g/min with MOSES, P = .01). On multivariable regression modeling, HoLAP without MOSES added 12 minutes to operating time (estimate 12.3, standard error 3.44, P < .01) after controlling for prostate size and laser energy usage. Duration of catheterization, urinary incontinence and need for reoperation within 3 months were similar. There were no differences between groups in International Prostate Symptom Score, quality of life, or postvoid residual at 3 months postoperatively. CONCLUSION: Utilization of MOSES technology resulted in improved efficiency in HoLAP, translating into time savings in the operating room. Postoperative outcomes out to 3 months were similar among patients who underwent the procedure utilizing either laser pulse mode. Further studies are needed to investigate long-term outcomes as the use of MOSES is likely to become more commonly utilized.


Subject(s)
Laser Therapy/methods , Lasers, Solid-State/therapeutic use , Lower Urinary Tract Symptoms/surgery , Prostatectomy/methods , Prostatic Hyperplasia/surgery , Aged , Humans , Laser Therapy/instrumentation , Laser Therapy/statistics & numerical data , Lower Urinary Tract Symptoms/etiology , Lower Urinary Tract Symptoms/psychology , Male , Middle Aged , Operative Time , Prostate/pathology , Prostate/surgery , Prostatectomy/instrumentation , Prostatectomy/statistics & numerical data , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/pathology , Quality of Life , Reoperation/statistics & numerical data , Retrospective Studies , Treatment Outcome
17.
BJU Int ; 127(1): 114-121, 2021 01.
Article in English | MEDLINE | ID: mdl-32623822

ABSTRACT

OBJECTIVE: To describe the crucial factors related to the implementation of the da Vinci single-port (SP) system (Intuitive Surgical Inc., Sunnyvale, CA, USA), and the early outcomes after the introduction of this robot for robot-assisted radical prostatectomy (RARP). PATIENTS AND METHODS: We prospectively collected data from 50 consecutive patients with prostate adenocarcinoma who underwent RARP using this robot. The median follow-up was 53 days. We performed a transperitoneal technique. The robotic (multiport) trocar was placed on the supra-umbilical midline 20 cm from the pubis and an assistant trocar placed in the right lower quadrant. We report our initial experience describing the intra- and postoperative outcomes associated with this new robot. Also, we report the early functional and oncological outcomes in the follow-up period considered. Continuous variables were described as medians and interquartile ranges, while categorical variables as frequencies and proportions. RESULTS: The median total operative time was 118 min, median console time was 80 min, and median estimated blood loss was 50 mL. There were no intraoperative complications or blood transfusions. The final pathology reported 18% Grade Group (GrGp)1, 58% GrGp2, 18% GrGp3, 2% GrGp4, and 4% GrGp5. In all, 40 patients (80%) were pT2 and 20% were ≥pT3a. The overall positive surgical margin rate was 14%. In all, 39 patients (78%) achieved full continence at median of 21 days after RARP. The median pain scale (0-10) score at 8, 12 and 16 h after RARP was 2, 2, and 0, respectively. CONCLUSION: The use of the da Vinci SP robot with an additional assistant port for RARP is technically safe and feasible, with acceptable short-term functional and oncological outcomes. However, there is a technical learning curve for this new platform due to the smaller scope of the operative field and the decreased flexibility and strength of the surgical instruments.


Subject(s)
Adenocarcinoma/surgery , Prostatectomy/methods , Prostatic Neoplasms/surgery , Robotic Surgical Procedures/methods , Adenocarcinoma/pathology , Blood Loss, Surgical , Humans , Learning Curve , Male , Margins of Excision , Middle Aged , Neoplasm Grading , Neoplasm Staging , Neoplasm, Residual , Operative Time , Pain, Postoperative/etiology , Penile Erection , Prostatectomy/adverse effects , Prostatectomy/instrumentation , Prostatic Neoplasms/pathology , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/instrumentation , Urinary Incontinence/etiology
18.
J Robot Surg ; 15(2): 179-185, 2021 Apr.
Article in English | MEDLINE | ID: mdl-32385798

ABSTRACT

Robotic prostatectomy is the most commonly performed robotic procedure in the United States. Increasing utilization of this procedure necessitates characterization of robot malfunctions and associated patient injuries. We performed a review of adverse events reported to a publicly available database. We searched the Manufacturer and User Facility Device Experience (MAUDE) database for reported adverse events (RAE) involving the intuitive surgical system. Reports involving prostatectomy from 2014 to 2019 were extracted and analyzed for data regarding death, patient injury, and device malfunction. Of 9109 reported adverse events (RAE), 602 were extracted for robotic prostatectomy over the study period. Seven were patient deaths (1.2%), 53 (8.8%) were patient injuries (Table 1), and 542 (90.0%) were malfunctions (Table 2). Malfunctions resulted in 25 aborted cases, 21 open conversions, and 25 laparoscopic conversions (71/542, 13.1%; Fig. 1). Instrument failures comprised the majority (76.4%) of malfunctions. Seven malfunctions (1.3%) resulted in patient injury. The most common device-related injury involved the monopolar curved scissors. No reported deaths were related to robot malfunction. Instrument failures comprise majority of the malfunctions of the Da Vinci robot during robot-assisted laparoscopic prostatectomy. When malfunctions do occur they are usually recoverable and rarely lead to patient injury.


Subject(s)
Data Analysis , Databases, Factual , Equipment Failure/statistics & numerical data , Intraoperative Complications/epidemiology , Intraoperative Complications/etiology , Laparoscopy/adverse effects , Laparoscopy/instrumentation , Prostatectomy/adverse effects , Prostatectomy/instrumentation , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/instrumentation , Wounds and Injuries/epidemiology , Wounds and Injuries/etiology , Humans , Laparoscopy/methods , Male , Prostatectomy/methods , Prostatectomy/mortality , Robotic Surgical Procedures/methods , Robotic Surgical Procedures/mortality , Time Factors
19.
World J Urol ; 39(7): 2627-2633, 2021 Jul.
Article in English | MEDLINE | ID: mdl-33025143

ABSTRACT

PURPOSE: In order to increase the efficiency of the low-power holmium laser enucleation of the prostate (LP-HoLEP), and introduce it as a standard surgery for BPH, we described a modified 'seven-step two-lobe' HoLEP (ST HoLEP) technique applying 60-W device in a stepwise manner. METHODS: From July 2016 to August 2019, 120 patients who received LP-HoLEP at our hospital because of urinary tract symptoms caused by BPH were included in the study. The patients were assigned into two groups, 60 consecutive patients received modified ST HoLEP compared with another preexisting 60 consecutive patients who received the conventional three-lobe HoLEP (T HoLEP) before the technical modification. The clinical parameters, including patient characteristics, perioperative data, as well as voiding outcomes, and complications were evaluated after at least 3-month follow-up. RESULTS: The median enucleation efficiency of the ST HoLEP was 0.72 gm/min, which was significantly higher than 0.62 gm/min of the T HoLEP. Despite the preoperative IPSS was slightly higher in T HoLEP group, the other preoperative and perioperative data showed no statistical difference between the two groups. After ST HoLEP procedure, the urinary incontinence rate was continually improved at 1-week, 1-month, and 3-month follow-up which were 13.3%, 6.7%, and 1.7%, respectively. There was no significant difference in postoperative voiding outcomes and urinary continence results in 3-month follow-up. CONCLUSION: The ST HoLEP technique was proved to increase the efficiency which was benefit from minimizing the surgical incision, facilitating the single surgical plane identification and maintenance during the whole enucleation procedure.


Subject(s)
Lasers, Solid-State/therapeutic use , Prostatectomy/instrumentation , Prostatectomy/methods , Prostatic Hyperplasia/surgery , Aged , Aged, 80 and over , Humans , Male , Middle Aged , Retrospective Studies , Treatment Outcome
20.
Urol Clin North Am ; 48(1): 35-44, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33218592

ABSTRACT

Laparoscopic prostatectomy was technically challenging and not widely adopted. Robotics led to the widespread adoption of minimally invasive prostatectomy, which has been used heavily, supplanting the open and traditional laparoscopic approach. The benefits of robotic prostatectomy are disputed. Data suggest that robotic prostatectomy outcomes have improved over time.


Subject(s)
Prostatectomy/history , Prostatic Neoplasms/history , Quality Improvement , Robotic Surgical Procedures/history , History, 19th Century , History, 20th Century , History, 21st Century , Humans , Laparoscopy , Male , Prostatectomy/instrumentation , Prostatectomy/methods , Prostatectomy/standards , Prostatic Neoplasms/surgery , Quality Improvement/standards , Robotic Surgical Procedures/instrumentation , Robotic Surgical Procedures/standards
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