RESUMEN
PURPOSE: We reported, as a referral center in prostate cancer, our perspectives and experience performing Telesurgery using robotic surgery and 5G network. MATERIAL AND METHODS: We described and illustrated the Telesurgery applications and outcomes to treat a patient with prostate cancer located 1300 kilometers away from the surgeon (Beijing-Harbin) in China. We used the Edge Medical Robot (MP1000) in November 2023 in a 71-year-old patient with Gleason 6 (ISUP 1) in 8 cores from 13, PSA of 14 ng/dL, and clinical stage cT2a. MRI described a PIRADS 5 nodule on the left peripheral zone at the base, and 20gr prostate. We described details about the connection between centers, perioperative outcomes, and our perspectives as a referral center in prostate cancer. RESULTS: We had no delays, or problems with network connection between the centers. The procedure was performed in 60 minutes, with no intra- or postoperative complications. Estimated blood loss was 100 mL. The patient was ambulating soon after anesthesia recovery. Final pathology described a Gleason 6 (ISUP 1) involving the left base and left seminal vesicle, negative surgical margins, and no lymph node involvement (pT3bN0). The patient was continent soon after catheter removal (7 days). CONCLUSION: As technological progress introduced novel robotic platforms and high-speed networks, the concept of Telesurgery became a tangible reality while 5G technology solved latency and transmission concerns. However, with these advancements, ethical considerations and regulatory frameworks should underline the importance of transparency and patient safety with responsible innovation in the field.
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Prostatectomía , Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Humanos , Masculino , Prostatectomía/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , Anciano , Telemedicina , Resultado del TratamientoRESUMEN
INTRODUCTION: Prostate cancer has a variable natural history and, despite the existence of biochemical recurrence (BCR) predictors, they are still limited in predicting outcomes. The role of testosterone in advanced prostate cancer is well known, however its role in localized prostate cancer is still uncertain. In the present study, we evaluated the relationship of testosterone levels and androgen receptor (AR) expression with oncological and functional outcomes, in patients undergoing radical retropubic prostatectomy (RRP). MATERIALS AND METHODS: Through a retrospective study, patients who underwent RRP, who had at least two preoperative total testosterone dosages, were analyzed and compared according to testosterone levels, oncological and functional outcomes. After analyzing data, tissue samples were selected in a biorepository to carry out the AR and the AR-V7 expression. RESULTS: After applying exclusion criteria, 212 patients were included in the analysis. Thirty-two patients (15.1%) had low testosterone levels and, in this group, a lower rates of erectile function recovery were observed at 24 months (53.1% vs. 71.7%; p = 0.037), a higher rate of BCR (21.9% vs. 9.4%; p = 0.041) and higher International Society of Urological Pathology (ISUP) grade in biopsy products. The AR expression was higher in patients with low testosterone, but there was no difference in relapse rates. CONCLUSIONS: Lower levels of testosterone were related to lower rates of erectile function recovery at the end of 24 months after RRP, in addition to conferring higher rates of BCR and higher ISUP grades in biopsy. Furthermore, patients with total testosterone < 300 ng/dL had higher expression of AR, but no difference in BCR rates.
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Prostatectomía , Neoplasias de la Próstata , Receptores Androgénicos , Testosterona , Humanos , Masculino , Prostatectomía/métodos , Testosterona/sangre , Receptores Androgénicos/metabolismo , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , Estudios Retrospectivos , Persona de Mediana Edad , Anciano , Resultado del Tratamiento , Recurrencia Local de NeoplasiaRESUMEN
INTRODUCTION: Robotic Radical Prostatectomy using the Da-Vinci Single-Port (SP) robot can provide comparable functional and oncological outcomes with potential advantages pertaining to peri-operative morbidity, especially in patients with an extensive history of prior abdominal surgeries (1, 2). MATERIALS AND METHODS: Our case is a 74-year-old male with a history of diabetes, cardiac bypass, hypertension, and hyperlipidemia, presenting with a PSA of 7.2. His MRI showed a PIRADS-5 lesion in the left apex and mid-gland peripheral zone, and he was diagnosed with unfavorable intermediate-risk prostate cancer after MRI guided fusion biopsy. His BMI was 31, and past surgical history was pertinent for two exploratory laparotomies due to gunshot wounds and a colostomy creation followed by reversal. The standardized steps of robotic radical prostatectomy were carried out using SP robotic platform performed by author SH (3, 4). RESULTS: Total operative time and estimated blood loss were 210 minutes and 150mL respectively. The patient was discharged on postoperative day one and final pathology showed adenocarcinoma of the prostate Gleason score 4+3=7, pT2NxR0 and negative surgical margins. The patient was continent four weeks after surgery and the PSA continues to be undetectable after three months. CONCLUSION: Transvesical Radical prostatectomy using the single port platform provides acceptable oncological and functional outcomes and quicker recovery given decreased risk of ileus and peritoneal irritation. Given that the abdominal cavity is not violated, the risk of bowel or vascular injury is mitigated, especially in patients with a hostile abdomen.
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Prostatectomía , Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Humanos , Masculino , Procedimientos Quirúrgicos Robotizados/métodos , Prostatectomía/métodos , Prostatectomía/efectos adversos , Anciano , Neoplasias de la Próstata/cirugía , Resultado del Tratamiento , Adenocarcinoma/cirugía , Tempo OperativoRESUMEN
PURPOSE: We assessed the prognostic impact of the 2012 Briganti nomogram on prostate cancer (PCa) progression in intermediate-risk (IR) patients presenting with PSA <10ng/mL, ISUP grade group 3, and clinical stage up to cT2b treated with robot assisted radical prostatectomy eventually associated with extended pelvic lymph node dissection. MATERIALS AND METHODS: From January 2013 to December 2021, data of surgically treated IR PCa patients were retrospectively evaluated. Only patients presenting with the above-mentioned features were considered. The 2012 Briganti nomogram was assessed either as a continuous and a categorical variable (up to the median, which was detected as 6%, vs. above the median). The association with PCa progression, defined as biochemical recurrence, and/or metastatic progression, was evaluated by Cox proportional hazard regression models. RESULTS: Overall, 147 patients were included. Compared to subjects with a nomogram score up to 6%, those presenting with a score above 6% were more likely to be younger, had larger/palpable tumors, presented with higher PSA, underwent tumor upgrading, harbored non-organ confined disease, and had positive surgical margins at final pathology. PCa progression, which occurred in 32 (21.7%) cases, was independently predicted by the 2012 Briganti nomogram both considered as a continuous (Hazard Ratio [HR]:1.04, 95% Confidence Interval [CI]:1.01-1.08;p=0.021), and a categorical variable (HR:2.32; 95%CI:1.11-4.87;p=0.026), even after adjustment for tumor upgrading. CONCLUSIONS: In IR PCa patients with PSA <10ng/mL, ISUP grade group 3, and clinical stage up to cT2b, the 2012 Briganti nomogram independently predicts PCa progression. In this challenging subset of patients, this tool can identify prognostic subgroups, independently by upgrading issues.
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Progresión de la Enfermedad , Clasificación del Tumor , Estadificación de Neoplasias , Nomogramas , Antígeno Prostático Específico , Prostatectomía , Neoplasias de la Próstata , Humanos , Masculino , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/sangre , Anciano , Persona de Mediana Edad , Estudios Retrospectivos , Prostatectomía/métodos , Antígeno Prostático Específico/sangre , Metástasis Linfática/patología , Escisión del Ganglio Linfático , Pronóstico , Factores de Riesgo , Medición de Riesgo/métodos , Ganglios Linfáticos/patologíaRESUMEN
INTRODUCTION: Robot-assisted radical prostatectomy (RARP) has become a popular surgical approach for localized prostate cancer due to its favorable oncological and functional outcomes, as well as lower morbidity. In cases of intermediate- and high-risk prostate cancer, bilateral pelvic lymphadenectomy (PLND) is recommended as an adjunct to RARP (1-3). Despite its benefits, PLND can lead to surgical complications, with postoperative lymphocele formation being the most common. Most postoperative lymphoceles are clinically insignificant with variable incidence, reaching up to 60% of cases 4. However, a small percentage of patients 2-8% may experience symptomatic lymphoceles (SL), which can cause significant morbidity (4, 5). SURGICAL TECHNIQUE: We perform our RARP technique with our standard approach in all patients (6). After vesicourethral anastomosis a modified PF created to prevent symptomatic lymphocele. We start by suturing the peritoneal fold on the right side, medially to the vas deferens, followed by a similar stitch on the left side to approximate the edges in the midline. A running suture bunches the bladder peritoneum from both sides, passing through the pubic bone periosteum to secure it in place (7). This approach keeps the lateral pelvic gutters open for lymphatic drainage, while allowing fluid drainage from the true pelvis into the abdomen. A pelvic ultrasound was done for all patients at 6 weeks post operative, and additional clinical follow-up was carried out at 3 months following surgery. CONSIDERATIONS: We have demonstrated a modified technique of peritoneal flap (PBFB) with an initial decrease in postoperative symptomatic lymphoceles, the technique is feasible, safe, does not add significant morbidity, and does not require a learning curve.
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Escisión del Ganglio Linfático , Linfocele , Prostatectomía , Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Vejiga Urinaria , Humanos , Masculino , Prostatectomía/métodos , Escisión del Ganglio Linfático/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , Vejiga Urinaria/cirugía , Linfocele/prevención & control , Linfocele/etiología , Colgajos Quirúrgicos , Resultado del Tratamiento , Complicaciones Posoperatorias/prevención & control , Reproducibilidad de los Resultados , Peritoneo/cirugíaRESUMEN
OBJECTIVE: To assess and compare the functional and quality of life results in patients treated with curative intent for localized prostate cancer during 2015 in our hospital. METHOD: 77 patients treated by radical prostatectomy or external radiotherapy with androgen deprivation were prospective enrolled. Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire at 3-year follow-up and Spanish Questionnaire on Quality of Life in Patients with Prostate Cancer (CAVIPRES-30) at diagnosis and at 3-year follow-up were registered. RESULTS: 68 patients were included, 39 patients treated by radical prostatectomy and 29 received external radiotherapy with androgen deprivation. Among the operated patients, 61.5% were dry and 17.9% use three or more daily pads, compared to 72.4% and 6.8%, respectively, in the radiotherapy group. 48.7% of prostatectomized patients reported very poor or no capacity to have a sufficiently rigid erection, compared to 69% of the radiated group. After surgery, 43.6% considered bad or very bad quality-of-life, compared to 68.9% in the radiotherapy group. In the comparison of the data of the pre- and post-treatment questionnaire can be seen that the patients had a superior perception before the procedure. CONCLUSIONS: Patients treated by surgery have a better perception of quality-of-life compared to those treated by radiotherapy.
OBJETIVO: Determinar y comparar los resultados funcionales y de calidad de vida de pacientes con cáncer de próstata tratados con intención curativa durante el año 2015 en nuestro centro. MÉTODO: Se incluyeron 77 pacientes sometidos a prostatectomía radical (PR) o radioterapia externa con terapia de deprivación androgénica (TDA). Se realizaron el Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) tras 3 años de seguimiento y el Cuestionario Español de Calidad de Vida en Pacientes con Cáncer de Próstata (CAVIPRES-30) al diagnóstico y a los 3 años. RESULTADOS: Se incluyeron 68 pacientes, 39 con PR y 29 con radioterapia más TDA. De los pacientes intervenidos, el 61.5% están secos y el 17.9% usan tres o más compresas, diarias frente al 72.4% y el 6.8%, respectivamente, en el grupo de radioterapia. El 48.7% de los prostatectomizados refieren erecciones muy malas o ninguna, frente al 69% de los radiados. Tras la cirugía, el 43.6% refieren mala o muy mala calidad de vida, frente al 68.9% de los radiados. En la comparación de los datos del cuestionario pre- y postratamiento, los pacientes tenían una percepción superior antes del procedimiento. CONCLUSIONES: Los pacientes tratados mediante cirugía tienen una mejor percepción de su calidad de vida relacionada con la salud que los radiados.
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Prostatectomía , Neoplasias de la Próstata , Calidad de Vida , Humanos , Masculino , Prostatectomía/métodos , Neoplasias de la Próstata/radioterapia , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/psicología , Anciano , Estudios Prospectivos , Persona de Mediana Edad , Antagonistas de Andrógenos/uso terapéutico , Encuestas y Cuestionarios , Disfunción Eréctil/etiología , Estudios de SeguimientoRESUMEN
BACKGROUND AND OBJECTIVE: Salvage robot assisted radical prostatectomy (sRARP) is performed for patients with biochemical or biopsy proven, localized prostate cancer recurrences after radiation or ablative therapies. Traditionally, sRARP has been avoided by lower volume surgeons due to technical demand and high complication rates. Post-radiation sRARP outcomes studies exist but remain few in number. With increasing use of whole gland and focal ablative therapies, updates on sRARP in this setting are needed. The aim of this narrative review is to provide an overview of recently reviewed studies on the oncologic outcomes, functional outcomes, and complications after post-radiation and post-ablative sRARP. Tips and tricks are provided to guide surgeons who may perform sRARP. MATERIALS AND METHODS: We performed a non-systematic literature search of PubMed and MEDLINE for the most relevant articles pertaining to the outlined topics from 2010-2022 without limitation on study design. Only case reports, editorial comments, letters, and manuscripts in non-English languages were excluded. Key Content and Findings: Salvage robotic radical prostatectomy is performed in cases of biochemical recurrence after radiation or ablative therapies. Oncologic outcomes after sRARP are worse compared to primary surgery (pRARP) though improvements have been made with the robotic approach when compared to open salvage prostatectomy. Higher pre-sRARP PSA levels and more advanced pathologic stage portend worse oncologic outcomes. Patients meeting low-risk, EAU-biochemical recurrence criteria have improved oncologic outcomes compared to those with high-risk BCR. While complication rates in sRARP are higher compared to pRARP, Retzius sparing approaches may reduce complication rates, particularly rectal injuries. In comparison to the traditional open approach, sRARP is associated with a lower rate of bladder neck contracture. In terms of functional outcomes, potency rates after sRARP are poor and continence rates are low, though Retzius sparing approaches demonstrate acceptable recovery of urinary continence by 1 year, post-operatively. CONCLUSIONS: Advances in the robotic platform and improvement in robotic experience have resulted in acceptable complication rates after sRARP. However, oncologic and functional outcomes after sRARP in both the post-radiation and post-ablation settings are worse compared to pRARP. Thus, when engaging in shared decision making with patients regarding the initial management of localized prostate cancer, patients should be educated regarding oncologic and functional outcomes and complications in the case of biochemically recurrent prostate cancer that may require sRARP.
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Laparoscopía , Prostatectomía , Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Terapia Recuperativa , Humanos , Prostatectomía/métodos , Prostatectomía/efectos adversos , Masculino , Terapia Recuperativa/métodos , Neoplasias de la Próstata/cirugía , Procedimientos Quirúrgicos Robotizados/métodos , Laparoscopía/métodos , Recurrencia Local de Neoplasia , Resultado del Tratamiento , Complicaciones PosoperatoriasRESUMEN
PURPOSE: Limited high-quality studies have compared robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy. We sought to compare their postoperative outcomes in a randomized setting. MATERIALS AND METHODS: In a single center, 354 men with newly diagnosed prostate cancer were assessed for eligibility; 342 were randomized (1:1). The primary outcome was 90-day complication rates. Functional outcomes and quality of life were assessed over 18 months, and oncological outcomes, biochemical recurrence-free survival, and additional treatment over 36 months. RESULTS: From 2014 to 18, 327 patients underwent surgery (retropubic radical prostatectomy = 156, RALP = 171). Complications occurred in 27 (17.3%) vs 19 (11.1%; P = .107). Patients undergoing RALP experienced lower median bleeding (250.0 vs 719.5 mL; P < .001) and shorter hospitalization time. Urinary EPIC (Expanded Prostate Cancer Index Composite) median scores were better for RALP over 18 months, with higher continence rate at 3 months (80.5% vs 64.7%; P = .002), 6 months (90.1% vs 81.6%; P = .036) and 18 months (95.4% vs 78.8%; P < .001). Sexual EPIC and Sexual Health Inventory for Men median scores were higher with RALP up to 12 months, while the potency rate was superior at 3 months (23.9% vs 5.3%; P = .001) and 6 months (30.6% vs 6.9%; P < .001). Quality of life over the 18 months and oncological outcomes over 36 months were not significantly different between arms. CONCLUSIONS: Complications at 90 days were similar. RALP showed superior sexual outcomes at 1 year, improved urinary outcomes at 18 months, and comparable oncological outcomes at 36 months. TRIAL REGISTRATION: Prospective Analysis of Robot-Assisted Surgery; NCT02292914. https://clinicaltrials.gov/ct2/show/NCT02292914?cond=NCT02292914&draw=2&rank=1.
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Laparoscopía , Complicaciones Posoperatorias , Prostatectomía , Neoplasias de la Próstata , Calidad de Vida , Procedimientos Quirúrgicos Robotizados , Humanos , Masculino , Prostatectomía/métodos , Prostatectomía/efectos adversos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Neoplasias de la Próstata/cirugía , Laparoscopía/métodos , Laparoscopía/efectos adversos , Persona de Mediana Edad , Anciano , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Resultado del TratamientoRESUMEN
OBJECTIVE: Radical prostatectomy is a therapeutic option in organ-confined prostate cancer. As the development of robotic systems progresses, the approach with this technology has begun to impact the functional and oncological outcomes of urological patients. The objective is to report the rate of pentafecta in patients undergoing robot-assisted radical prostatectomy (RARP) stratified by risk groups. METHOD: Retrospective, observational, descriptive study from 2013 to 2020 that included 112 patients undergoing RARP. RESULTS: A rate of pentafecta at 12 months of follow-up of 35.7% (n = 40) was obtained. In the subanalysis by risk groups, at 1-year follow-up, was obtained an index of 43% (n = 26), 26% (n = 9) and 22% (n = 4) in low-, intermediate-, and high-risk patients, respectively. CONCLUSIONS: Prostatectomy showed functional and oncological results similar to those reported in the literature with robotic approach, regardless of the risk group for prostate cancer.
OBJETIVO: La prostatectomía radical es la alternativa terapéutica de elección en el cáncer de próstata confinado al órgano. Conforme avanza el desarrollo de los sistemas robóticos, el abordaje con esta tecnología ha comenzado a impactar en los desenlaces funcionales y oncológicos de los pacientes urológicos. El objetivo es reportar el índice de pentafecta en pacientes sometidos a prostatectomía radical asistida por robot (PRRA) estratificados por grupos de riesgo. MÉTODO: Estudio retrospectivo, observacional, descriptivo, de 2013 a 2020, que incluyó 112 pacientes sometidos a PRAR. RESULTADOS: Se obtuvo un índice de pentafecta a 12 meses de seguimiento del 35.7% (n = 40). En el subanálisis por grupos de riesgo, al año de seguimiento, se obtuvieron unos índices del 43% (n = 26), el 26% (n = 9) y el 22% (n = 4) en los pacientes de bajo, intermedio y alto riesgo, respectivamente. CONCLUSIONES: La prostatectomía demostró resultados funcionales y oncológicos similares a lo reportado en la literatura con abordaje robótico independientemente del grupo de riesgo del cáncer de próstata.
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Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Robótica , Masculino , Humanos , Procedimientos Quirúrgicos Robotizados/métodos , Estudios Retrospectivos , Prostatectomía/efectos adversos , Prostatectomía/métodos , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/etiología , Resultado del TratamientoRESUMEN
INTRODUCTION: The superiority of the functional results of robot-assisted radical prostatectomyis still controversial. Despite this, it is known that minimally invasive surgery obtains better results when analyzing blood loss, blood transfusion and length of stay, for example. Several studies have analyzed the impact of the resident physician's involvement on the results of urological surgeries. The simple learning curve for robot-assisted radical prostate surgery is estimated to be around 10 to 12 cases. Learning curve data for robotic surgeons is heterogeneous, making it difficult to analyze. Rare studies compare the results of a radical prostatectomy of an inexperienced surgeon starting his training in open surgery, with the results of the same surgeon, a few years later, starting training in robotic surgery. OBJECTIVE: to analyze the results of open radical prostatectomy surgeries (ORP) performed by urology residents, comparing them to the results of robot-assisted radical prostatectomy (RARP), performed by these same surgeons, after completing their training in urology. MATERIALS AND METHODS: a retrospective analysis of the cases of only 3 surgeons was performed. 50 patients underwent ORP (group A). The surgeons who operated on the ORP patients were in the 3rd and final year of the urology residency program and beginners in ORP surgery, but with at least 4 years of experience in open surgery. The same surgeons, already trained urologists, began their training in robotic surgery and performed 56 RARP surgeries (group B). For the comparative analysis, data were collected on age, number of lymph nodes removed, surgery time, hospitalization time, drain volume, drain permanence time, indwelling bladdercateter (IBC) permanence time, positive surgical margin, biochemical recurrence, risk classification (ISUP), intra and postoperative complications, urinary incontinence (UI) and erectile dysfunction (ED). The console used was the Da Vinci Si, from Intuitive®. For statistical analysis, the Shapiro-Wilk test verified that the data did not follow normality, the Levene test guaranteed homogeneity, and the Mann-Whitney test performed the comparative analysis of the quantitative data. For the analysis of qualitative data, the Chi-square test was used for nominal variables and the Mann-Whitney U test for ordinal variables. Additionally, the Friedman test analyzed whether there was an improvement in the perception of UI or ED over the months, for each group individually (without comparing them), and the post-hoc Durbin-Conover test, for the results with statistically significant difference. We used a p-value < 0.05, and the Jamovi® program (Version 2.0). RESULTS: there was no statistically significant difference between the groups for age, number of lymph nodes removed, positive surgical margin, biochemical recurrence, risk classification and urinary incontinence. Additionally, we observed that the surgical time was longer in group B. On the other hand, the length of stay, drain volume, drain time, IBC time, complication rate and levels of erectile dysfunction in the third and sixth months were higher in group A, when compared to group B. We also observed that there was no evolutionary improvement in ED over the months in both groups, and that there was a perception of improvement in UI from the 1st to the 3rd month in group A, and from the 1st to the 6th month, and from the 3rd to the 12th month, in group B. CONCLUSION: the learning curve of RARP is equivalent to the curve of ORP. In general, the results for the robotic group were better, however, the functional results were similar between the groups, with a slight tendency of advantage for the robotic arm.
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Disfunción Eréctil , Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Robótica , Incontinencia Urinaria , Urología , Masculino , Humanos , Procedimientos Quirúrgicos Robotizados/métodos , Próstata/patología , Estudios Retrospectivos , Curva de Aprendizaje , Márgenes de Escisión , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , Resultado del Tratamiento , Prostatectomía/métodos , Incontinencia Urinaria/cirugía , Transfusión SanguíneaRESUMEN
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.
Asunto(s)
Humanos , Prostatectomía/instrumentación , Neoplasias de la Próstata/cirugía , Procedimientos Quirúrgicos Robotizados/instrumentación , Eficacia , Análisis Costo-Beneficio/economíaRESUMEN
OBJECTIVE: To clarify the composition of lesions in different magnetic resonance imaging (MRI) partitions of positive surgical margins (PSM) after laparoscopic radical prostatectomy, explore the influence of lesion location on PSM, and construct a clinical prediction model to predict the risk of PSM. MATERIALS AND METHODS: This retrospective cohort study included 309 patients who underwent laparoscopic radical prostatectomy from 2018 to 2021 in our center was performed. 129 patients who met the same criteria from January to September 2022 were external validation cohorts. RESULTS: The incidence of PSM in transition zone (TZ) lesions was higher than that in peripheral zone (PZ) lesions. The incidence of PSM in the middle PZ was lower than that in other regions. Prostate specific antigen (PSA), clinical T-stage, the number of positive cores, international society of urological pathology (ISUP) grade (biopsy), MRI lesion location, extracapsular extension, seminal vesicle invasion (SVI), pseudo-capsule invasion (PCI), long diameter of lesions, lesion volume, lesion volume ratio, PSA density were related to PSM. MRI lesion location and PCI were independent risk factors for PSM. Least absolute shrinkage and selection operator (LASSO) regression was used to construct a clinical prediction model for PSM, including five variables: the number of positive cores, SVI, MRI lesion location, long diameter of lesions, and PSA. CONCLUSION: The positive rate of surgical margin in middle PZ was significantly lower than that in other regions, and MRI lesion location was an independent risk factor for PSM.
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Laparoscopía , Imagen por Resonancia Magnética , Márgenes de Escisión , Prostatectomía , Neoplasias de la Próstata , Humanos , Masculino , Prostatectomía/métodos , Laparoscopía/métodos , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/diagnóstico por imagen , Estudios Retrospectivos , Imagen por Resonancia Magnética/métodos , Persona de Mediana Edad , Anciano , Antígeno Prostático Específico/sangre , Factores de Riesgo , Medición de Riesgo/métodos , Clasificación del Tumor , Estadificación de NeoplasiasRESUMEN
OBJECTIVE: In the following years after the United States Preventive Service Task Force (USPSTF) recommendation against prostate cancer screening with PSA in 2012, several authors worldwide described an increase in higher grades and aggressive prostate tumors. In this scenario, we aim to evaluate the potential impacts of USPSTF recommendations on the functional and oncological outcomes in patients undergoing robotic-assisted radical prostatectomy (RARP) in a referral center. MATERIAL AND METHODS: We included 11396 patients who underwent RARP between 2008 and 2021. Each patient had at least a 12-month follow-up. The cohort was divided into two groups based on an inflection point in the outcomes at the end of 2012 and the beginning of 2013. The inflection point period was detected by Bayesian regression with multiple change points and regression with unknown breakpoints. We reported continuous variables as median and interquartile range (IQR) and categorical variables as absolute and relative percent frequencies. RESULTS: Group 1 had 4760 patients, and Group 2 had 6636 patients, with a median follow-up of 109 and 38 months, respectively. In the final pathology, Group 2 had 9.5% increase in tumor volume, 24% increase on Gleason ≥ 4+3 (ISUP 3) , and 18% increase on ≥ pT3. This translated to a 6% increase in positive surgical margins and 24% reduction in full nerve sparing in response to the worsening pathology. There was a significant decline in post-operative outcomes in Group 2, including a 12-month continence reduction of 9%, reduction in potency by 27%, and reduction of trifecta by 22%. CONCLUSIONS: The increasing number of high-risk patients has led to worse functional and oncologic outcomes. The initial rapid rise in PSM was leveled by the move towards more partial nerve sparing. Among some historical changes in prostate cancer diagnosis and management in the period of our study, the USPSTF recommendation coincided with worse outcomes of prostate cancer treatment in a population who could benefit from PSA screening at the appropriate time.
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Prostatectomía , Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Humanos , Masculino , Teorema de Bayes , Detección Precoz del Cáncer , Antígeno Prostático Específico , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND: Multiparametric magnetic resonance imaging (mpMRI) is increasingly used for risk stratification and preoperative staging of prostate cancer. It remains unclear how Grade Group (GG) interacts with the ability of mpMRI to determine the presence of extraprostatic extension (EPE) on surgical pathology. METHODS: A retrospective review of a robotic assisted laparoscopic radical prostatectomy (RALP) database from 2016-2020 was performed. Radiology mpMRI reports by multiple attending radiologists and without clear standardization or quality control were retrospectively assessed for EPE findings and compared with surgical pathology reports. The data were stratified by biopsy-based GG and a multivariable cluster analysis was performed to incorporate additional preoperative variables (age at diagnosis, PSA, etc.). Hazard ratios were calculated to determine how mpMRI findings and radiographic EPE relate to positive surgical margins. RESULTS: 289 patients underwent at least one mpMRI prior to RALP. Preoperative mpMRI demonstrated sensitivity of 39.3% and specificity of 88.8% for pathological EPE and had a negative predictive value (NPV) of 49.5%, and positive predictive value (PPV) of 84.0%. Stratification of NPV by GG yielded the following values: GG 1-5 (49.5%), GG 3-5 (40.8%), GG 4-5 (43.4%), and GG 5 (30.4%). Additionally, positive EPE on preoperative mpMRI was associated with a significantly decreased risk of positive surgical margins (RR: 0.655; 95% CI: 0.557-0.771). CONCLUSIONS: NPV of prostate mpMRI for EPE may be decreased for higher grade tumors. A detailed reference reading and image quality optimization may improve performance. However, urologists should exercise caution in nerve sparing approaches in these patients.
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Imágenes de Resonancia Magnética Multiparamétrica , Neoplasias de la Próstata , Masculino , Humanos , Imagen por Resonancia Magnética/métodos , Estudios Retrospectivos , Márgenes de Escisión , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , ProstatectomíaRESUMEN
OBJECTIVE: To present the patient-reported quality of life (QoL) outcomes from a prospective, randomized controlled trial comparing the use of pelvic floor muscle training (PFMT) and duloxetine after robot-assisted radical prostatectomy (RARP). METHODS: We identified 213 men with organ-confined disease having post-RARP urinary incontinence who were randomly assigned to received PFMT, duloxetine, combined PFMT-duloxetine and pelvic floor muscle home exercises. Urinary symptoms burden was measured by marked clinical important difference improvement (MCID) defined by using the International Prostate Symptom Score (IPSS) difference of - 8 points (ΔIPSS ≤-8). QoL was assessed according to Visual Analog Scale (VAS), King's Health Questionnaire (KQH), and International Index of Erectile Function (IIEF-5). Multivariable regression analyses aimed to predict MCID, burden of urinary symptoms (IPSS ≥8), and patients reporting to be satisfied (IPSS QoL ≤2) or comfortable (VAS ≤1) post-RARP. RESULTS: Moderate to severe urinary symptoms decreased from 48% preoperatively to 40%, 34%, and 23% at 3, 6, and 12months post-RARP. After surgery, MCID improvement was observed in 19% of patients, and deterioration in 3.3%. Large prostate was the only factor associated to MCID (OR 1.03 [95%CI 1.01-1.05], P = .005). At 6months, patients reached the same degree of preoperative satisfaction. Neurovascular bundle preservation was the only predictor of being comfortable regarding urinary symptoms postoperatively (OR 12.8 [CI95% 1.47-111.7], P = .02 at 3months) and was also associated to higher median postoperative IIEF-5. CONCLUSION: Despite urinary incontinence following RARP, patients with larger prostates experience a reduction of lower urinary tract symptoms within a year, which subsequently elevates QoL. Furthermore, nerve-sparing surgery augments erectile function and urinary outcomes, shaping postoperative QoL.
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Disfunción Eréctil , Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Robótica , Incontinencia Urinaria , Masculino , Humanos , Próstata , Calidad de Vida , Estudios Prospectivos , Clorhidrato de Duloxetina , Disfunción Eréctil/cirugía , Resultado del Tratamiento , Prostatectomía , Neoplasias de la Próstata/cirugíaRESUMEN
BACKGROUND: New biomarkers of progression in patients with prostate cancer (PCa) are needed to improve their classification and clinical management. This systematic review investigated the relationship between single nucleotide polymorphisms (SNPs) and PCa progression. METHODS: A keyword search was performed in Pubmed, EMBASE, Scopus, Web of Science, and Cochrane for publications between 2007 and 2022. We included articles with adjusted and significant associations, a median follow-up greater than or equal to 24 months, patients taken to radical prostatectomy (RP) as a first therapeutic option, and results presented based on biochemical recurrence (BCR). RESULTS: In the 27 articles selected, 73 SNPs were identified in 39 genes, organized in seven functional groups. Of these, 50 and 23 SNPs were significantly associated with a higher and lower risk of PCa progression, respectively. Likewise, four haplotypes were found to have a significant association with PCa progression. CONCLUSION: This article highlights the importance of SNPs as potential markers of PCa progression and their possible functional relationship with some genes relevant to its development and progression. However, most variants were identified only in cohorts from two countries; no additional studies reproduce these findings.
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Polimorfismo de Nucleótido Simple , Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/genética , Neoplasias de la Próstata/cirugía , Próstata , Prostatectomía/métodos , Recurrencia Local de Neoplasia/genéticaRESUMEN
OBJECTIVES: Within the tertiary-case database, the authors tested for differences in long-term continence rates (≥ 12 months) between prostate cancer patients with extraprostatic vs. organ-confined disease who underwent Robotic-Assisted Radical Prostatectomy (RARP). METHOD: In the institutional tertiary-care database the authors identified prostate cancer patients who underwent RARP between 01/2014 and 01/2021. The cohort was divided into two groups based on tumor extension in the final RARP specimen: patients with extraprostatic (pT3/4) vs. organ-confined (pT2) disease. Additionally, the authors conducted subgroup analyses within both the extraprostatic and organ-confined disease groups to compare continence rates before and after the implementation of the new surgical technique, which included Full Functional-Length Urethra preservation (FFLU) and Neurovascular Structure-Adjacent Frozen-Section Examination (NeuroSAFE). Multivariable logistic regression models addressing long-term continence were used. RESULTS: Overall, the authors identified 201 study patients of whom 75 (37 %) exhibited extraprostatic and 126 (63 %) organ-confined disease. There was no significant difference in long-term continence rates between patients with extraprostatic and organ-confined disease (77 vs. 83 %; p = 0.3). Following the implementation of FFLU+ NeuroSAFE, there was an overall improvement in continence from 67 % to 89 % (Δ = 22 %; p < 0.001). No difference in the magnitude of improved continence rates between extraprostatic vs. organ-confined disease was observed (Δ = 22 % vs. Δ = 20 %). In multivariable logistic regression models, no difference between extraprostatic vs. organ-confined disease in long-term continence was observed (Odds Ratio: 0.91; p = 0.85). CONCLUSION: In this tertiary-based institutional study, patients with extraprostatic and organ-confined prostate cancer exhibited comparable long-term continence rates.
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Laparoscopía , Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Masculino , Humanos , Procedimientos Quirúrgicos Robotizados/métodos , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , Prostatectomía/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: There is a tendency of prompted global health systems to reduce the length of hospital stay without compromising patient safety or satisfaction. We evaluated the safety and viability of early discharge in patients undergoing minimally invasive radical prostatectomy (MIRP), as well as patient satisfaction with this strategy. METHODS: This longitudinal prospective study included 72 patients who underwent MIRP for prostate cancer. Three groups were performed according to the day of hospital discharge following surgery: same day (G1), first day after (G2), and second day after (G3). Satisfaction, adverse events, and readmission were analyzed for each group. Associations between clinicopathologic variables and same-day discharge were analyzed by comparing data between G1 patients who did and did not achieve same-day discharge. RESULTS: 16.7% of patients were not discharged according to randomization (10 randomized to G1). 80% of G1 patients who did not achieve same-day discharge had Gleason scores of 3 + 4 or 4 + 3, which were observed in 35.7% of patients discharged on the same day (P < 0.05). Average prostate weight was significantly lower in patients who achieved same-day discharge than in those who did not (P < 0.01). Univariable logistic regression points to Gleason scores of 3 + 4 or 4 + 3 as the main factors associated with unsuccessful same-day discharge (P < 0.05). There were no significant differences in satisfaction scores. CONCLUSIONS: Same-day discharge was both safe and feasible and does not appear to affect satisfaction in a subset of patients with prostate cancer. Surgeons should consider the Gleason score when determining whether same-day discharge is appropriate.
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Laparoscopía , Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Masculino , Humanos , Satisfacción del Paciente , Próstata , Estudios Prospectivos , Alta del Paciente , Prostatectomía , Neoplasias de la Próstata/cirugíaRESUMEN
BACKGROUND AND OBJECTIVES: Radical prostatectomy (RP) is a definitive surgical therapy for localized prostate cancer. Evidence suggests that the poor ergonomics of surgeons during RP may lead to work-related musculoskeletal disorders and loss of productivity. Since each surgery modality has its physical demands, we compared the ergonomic risk between laparoscopic (LRP) and robotic-assisted (RARP) radical prostatectomy. METHODS: The study assessed the posture of 10 urological surgeons during LRP and RARP surgeries with the Rapid Entire Body Assessment (REBA) scale. RESULTS: We found that the RARP approach resulted in lower REBA scores over the LRP procedure. CONCLUSIONS: Robotic surgery improves body posture for the urological surgeon like in other medical specialties. However, the surgeons display harmful postures in both surgeries.