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1.
Minerva Urol Nephrol ; 76(5): 596-605, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39320250

RESUMEN

BACKGROUND: This study aims to prospectively compare the outcomes of robot-assisted radical prostatectomy (RARP) performed using the Hugo RAS and da Vinci Xi systems, focusing on the postoperative course, pathological findings, and health-related quality of life. METHODS: The COMPAR-P trial, a prospective post-market study (clinical-trials.org NCT05766163), commenced in March 2023, enrolling patients for RARP performed with either da Vinci or Hugo RAS without selection criteria for up to 50 consecutive cases per system. Two experienced console surgeons performed the procedures according to a standardized technique. The study evaluated differences between da Vinci and Hugo RAS regarding the postoperative course, pathology findings, 30-day PSA value, functional metrics, and health-related quality of life using SF-36 and University of California Los Angeles Prostate Cancer Index questionnaires. RESULTS: Fifty patients underwent DV-RARP and H-RARP each. Postoperative complications, pathological data, and quality of life metrics did not significantly differ between the groups. Noteworthy limitations include the comparison between the first 50 H-RARP and last 50 DV-RARP cases, as well as the potential influence of surgeons' specialized expertise on the generalizability of findings. CONCLUSIONS: This prospective study of 100 unselected patients undergoing RARP with either da Vinci or Hugo RAS systems reveals comparable outcomes in postoperative course, pathology, functional metrics, and health-related quality of life. However, further research with larger sample sizes, longer follow-up periods, and diverse surgical expertise is essential to validate these findings and better understand the implications for clinical practice.


Asunto(s)
Prostatectomía , Neoplasias de la Próstata , Calidad de Vida , Procedimientos Quirúrgicos Robotizados , Humanos , Prostatectomía/métodos , Masculino , Estudios Prospectivos , Persona de Mediana Edad , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , Anciano , Resultado del Tratamiento , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología
2.
Urol Oncol ; 2024 Aug 19.
Artículo en Inglés | MEDLINE | ID: mdl-39164149

RESUMEN

PURPOSE: To systematically compare the evidence about surgical outcomes, postoperative complications, and sequelae of Radical cystectomy with urinary diversion with or without stent placement. MATERIAL AND METHODS: A literature search was performed through PubMed, Scopus®, and Web of Science up to December 2023 in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. The study protocol was registered in PROSPERO (CRD 42023492384), and the research question was formulated according to the PICOs model. Three comparative studies were identified, 2 randomized and 1 prospective coming from a randomized cohort. RESULTS: The stent group showed higher odds of postoperative major complications (OR 3.00 - 95%CI 1.06; 8.52; P = 0.04) than the stentless group. There was no statistically significant difference between the 2 groups regarding 30-day readmission (P = 0.06), postoperative uretero-ileal anastomotis stricture (UIAS) (P = 0.09), postoperative uretero-ileal anastomotis leak (UIAL) (P = 0.20), postoperative urinary tract infections (UTIs) (P = 0.08), and postoperative ureteral obstruction (P = 0.35). No statistically significant difference between the 2 groups was found regarding UIAS management in terms of ureteral reimplantation (P = 0.28) or dilatation (P = 0.36). CONCLUSIONS: Our pooled data analysis shows no statistically significant difference between stentless and stented urinary diversion after radical cystectomy. Stentless could be a reasonable choice when performing diversion during radical cystectomy.

3.
J Endourol ; 2024 Aug 28.
Artículo en Inglés | MEDLINE | ID: mdl-39135470

RESUMEN

Background: To report the surgical and functional outcomes of the holmium laser enucleation of the prostate (HoLEP) surgical program implemented at a high-volume tertiary referral center and to estimate the learning curve (LC) duration for this surgical procedure. Methods: Data of all consecutive patients undergoing HoLEP at the University of Verona between June 2022 and April 2024 were retrieved from a prospectively maintained institutional database of patients undergoing benign prostatic hyperplasia (BPH) surgical treatment. The primary endpoint was functional outcomes evaluation during the surgeons' LC. The secondary endpoint was to define the surgical LC for HoLEP. A multivariable test of means was performed to compare functional outcomes at different time points. After adjusting for potential confounders (age, preoperative pharmacotherapy, and prostate volume), multivariable linear regression models were fitted to evaluate the effect of experience on operative time (OT) and enucleation efficiency. To assess LCs for HoLEP surgery, the non-risk-adjusted cumulative sum (CUSUM) method was used. Results: A statistically significant improvement in International Prostate Symptoms Score (IPSS) score, delta% IPSS score, IPSS quality of life (IPSS-QoL) score, and delta% IPSS-QoL score was observed over the study period. Furthermore, the incidence of irritative symptoms (p < 0.001) and stress incontinence (p = 0.01) significantly decreased over time, with a 12-month incidence of 8.4% and 9.5%, respectively. A statistically significant association between experience and both OT and enucleation efficiency was observed in multivariable linear regression analysis. The CUSUM chart for OT and enucleation efficiency showed a steep initial upward/downward trend of ∼50 cases each, and a plateau until ∼100 procedures are reached, where the breakpoint is recognized for both variables and where the CUSUM curve goes below the locally weighted scatterplot smoothing curve in the corresponding observed-expected CUSUM plot. Conclusions: HoLEP represents an effective treatment for BPH, demonstrating significant improvement in BPH-related symptoms over the study period, despite the considerable LC of ∼50 cases associated with the procedure.

4.
Biomacromolecules ; 25(6): 3741-3755, 2024 Jun 10.
Artículo en Inglés | MEDLINE | ID: mdl-38783486

RESUMEN

The development of efficient and biocompatible contrast agents is particularly urgent for modern clinical surgery. Nanostructured materials raised great interest as contrast agents for different imaging techniques, for which essential features are high contrasts, and in the case of precise clinical surgery, minimization of the signal spatial dispersion when embedded in biological tissues. This study deals with the development of a multimodal contrast agent based on an injectable hydrogel nanocomposite containing a lanthanide-activated layered double hydroxide coupled to a biocompatible dye (indocyanine green), emitting in the first biological window. This novel nanostructured thermogelling hydrogel behaves as an efficient tissue marker for optical and magnetic resonance imaging because the particular formulation strongly limits its spatial diffusion in biological tissue by exploiting a simple injection. The synergistic combination of these properties permits to employ the hydrogel ink simultaneously for both optical and magnetic resonance imaging, easy monitoring of the biological target, and, at the same time, increasing the spatial resolution during a clinical surgery. The biocompatibility and excellent performance as contrast agents are very promising for possible use in image-guided surgery, which is currently one of the most challenging topics in clinical research.


Asunto(s)
Medios de Contraste , Imagen por Resonancia Magnética , Medios de Contraste/química , Imagen por Resonancia Magnética/métodos , Animales , Humanos , Cirugía Asistida por Computador/métodos , Nanoestructuras/química , Hidrogeles/química , Tinta , Ratones , Verde de Indocianina/química , Verde de Indocianina/administración & dosificación , Materiales Biocompatibles/química , Imagen Óptica/métodos
5.
Eur Urol Open Sci ; 63: 104-112, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38591096

RESUMEN

Background and objective: The Hugo RAS and DaVinci Xi systems are used for performing robot-assisted radical prostatectomy (RARP). This study aims to compare these two platforms providing granular and comprehensive data on their intraoperative performance. Methods: The Comparison of Outcomes of Multiple Platforms for Assisted Robotic surgery-Prostate (COMPAR-P) trial is a prospective post-market study (clinicaltrials.org NCT05766163). Enrollment began in March 2023, allocating patients to DaVinci or Hugo RAS for RARP, without selection criteria, for up to 50 consecutive cases. Two experienced console surgeons performed the procedures, following the same technique. Evaluation focused on timing, learning curves, malfunctioning events, complications, and users' satisfaction, using standard statistical methods, including the cumulative summation analysis (CUSUM) for the learning curve assessment. Key findings and limitations: Fifty patients each were enrolled for DaVinci (DV-RARP) and Hugo RAS (H-RARP) RARP. Baseline features were balanced. DV-RARP showed significantly shorter "setup" and "console" phase durations than H-RARP (37 vs 55 min and 97 vs 126 min, respectively, p < 0.001). A longitudinal timing analysis revealed DV-RARP's flat line, while H-RARP showed a modest decline with breakpoints at 22 and 17 procedures by CUSUM for the setup and console phases. The numbers of malfunctioning events were 4 (DV-RARP) and 20 (H-RARP). DV-RARP had high user satisfaction, while the user satisfaction of H-RARP varied. The comparison was between the first 50 H-RARP and the last 50 DV-RARP cases performed at our institution. This likely accounts for the observed differences in setup and console times between the cohorts. The specialized expertise of the surgeons involved could limit the generalizability of our findings. Conclusions and clinical implications: This prospective study compared unselected patients who underwent DV-RARP and H-RARP. More malfunctioning events occurred in case of Hugo RAS, but surgical outcomes were similar. Longer operative times for Hugo RAS were attributed to meticulous care with the novel platform. Improvement potential was evident within a few procedures, providing valuable insights for adopting this new platform. Patient summary: This study compared two advanced robotic systems, DaVinci and Hugo RAS, used to remove the prostate in patients diagnosed with prostate cancer. While both systems showed similar surgical outcomes, the newer Hugo RAS system required more meticulous movements, leading to slightly longer operation times. The findings suggest that, with further experience, both systems can provide effective treatment options for patients undergoing prostate surgery.

6.
Urology ; 188: 70-76, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38499187

RESUMEN

OBJECTIVE: To conduct a comparative cost analysis between single-use and reusable cystoscopes from a national healthcare system perspective and assess the environmental footprint. METHODS: Single-center micro-cost analysis of reusable vs single-use cystoscopes used institutional data. The cost breakdown included capital, reprocessing, repair, procedure, and environmental impact expenses. Data collection occurred in 2022, utilizing registered data, observations, and expert opinions. Depreciation was applied over 5 years for reusable cystoscopes and 8 years for the automated endoscope reprocessor. Deterministic sensitivity analyses gauged result robustness to input variations. Lastly, an assessment of the environmental footprint, focusing on water consumption and waste generation, was conducted. RESULTS: Per-procedure cost associated with reusable cystoscopes was €332.46 vs €220.19 associated with single-use, resulting in savings of €112.27. When projecting these costs per procedure with the number of procedures performed in 2022 (1186), comparing the costs of procedures performed in 1 year with reusable endoscopes (€394,295.86) to the costs of the exact number of procedures performed with disposable endoscopes (€261,149.37), a saving of €133,146.49 could be achieved. Additionally, after continuous use of single-use endoscopes, procedures were scheduled every 20 minutes instead of every 30 minutes. This adjustment allowed for 15 daily procedures instead of 10 while maintaining the same shift. This suggests potential advantages in terms of improved organizational impact and reduced waiting lists. Ultimately, the decreased environmental impact favored the adoption of single-use cystoscopes. CONCLUSION: Our study presents an opportunity for organizational development in response to the evolving external environment, considering user needs, market dynamics, and competition with other facilities.


Asunto(s)
Costos y Análisis de Costo , Cistoscopios , Equipos Desechables , Equipo Reutilizado , Equipo Reutilizado/economía , Equipos Desechables/economía , Cistoscopios/economía , Humanos , Ambiente
7.
Minerva Urol Nephrol ; 76(2): 235-240, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38270908

RESUMEN

Herein we report our first experience with Hugo RAS™ proposing a mirrored approach with different angles. Two experienced surgeons performed 10 prostatectomies (six with the standard approach and four with the mirrored one). The median docking time was 12.5 (IQR 12-15) vs. 13.5 (IQR 12-20) minutes. The median console time was 229 (174-245) vs. 172 (IQR 164-191) minutes. None of the procedures required conversion to open surgery. The study proves the versatility of the Hugo RAS™ to perform robot-assisted radical prostatectomy with two different docking angles and might be useful for novel users to adopt the preferred approach.


Asunto(s)
Prostatectomía , Neoplasias de la Próstata , Procedimientos Quirúrgicos Robotizados , Prostatectomía/métodos , Humanos , Masculino , Procedimientos Quirúrgicos Robotizados/métodos , Neoplasias de la Próstata/cirugía , Persona de Mediana Edad , Anciano , Tempo Operativo
8.
Clin Genitourin Cancer ; 22(2): 402-412.e17, 2024 04.
Artículo en Inglés | MEDLINE | ID: mdl-38281877

RESUMEN

Poly (ADP-ribose) polymerase inhibitors (PARPi) represent an option in selected cases of metastatic castration-resistant prostate cancer (mCRPC). The aim of the present systematic review and meta-analysis is to evaluate the efficacy and safety of approved (Olaparib, Rucaparib) and investigational (Talazoparib, Niraparib, Veliparib) PARPi in mCRPC patients. Three databases were queried for studies analyzing oncological outcomes and adverse events of mCRPC patients receiving PARPi. Primary outcome was a PSA decline ≥ 50% from baseline. Secondary outcomes were objective response rate, progression-free survival (PFS), radiological PFS, overall survival (OS), conversion of circulating tumor cell count, and time to PSA progression. The number and rate of any grade adverse events (AEs), grade ≥ 3 AEs, and most common grade ≥ 3 AEs were registered. A subanalysis of outcomes per mutation type, prospective trials, and studies adopting combination therapies was performed. Overall, 31 studies were included in this systematic review, 28 of which are available for meta-analysis. The most frequently investigated drug was Olaparib. The most frequent mutation was BRCA2. A PSA decline rate of 43% (95% CI 0.32-0.54) was observed in the overall population. Mean OS was 15.9 (95% CI 12.9-19.0) months. In BRCA2 patients, PSA decline rate was 66% (95% CI 0.57-0.7) and OS 23.4 months (95% CI 22.8-24.1). Half of the patients suffered from grade 3 and 4 AEs (0.50 [95% CI 0.39-0.60]). Most common AEs were hematological, the most frequent being anemia (21.5%). PARP inhibitors represent a viable option for mCRPC patients. Current evidence suggests an increased effectiveness in homologous recombination repair (HRR) gene mutation carriers, especially BRCA2.


Asunto(s)
Inhibidores de Poli(ADP-Ribosa) Polimerasas , Neoplasias de la Próstata Resistentes a la Castración , Masculino , Humanos , Inhibidores de Poli(ADP-Ribosa) Polimerasas/efectos adversos , Neoplasias de la Próstata Resistentes a la Castración/tratamiento farmacológico , Neoplasias de la Próstata Resistentes a la Castración/genética , Neoplasias de la Próstata Resistentes a la Castración/patología , Antígeno Prostático Específico , Estudios Prospectivos , Mutación
9.
Diagnostics (Basel) ; 13(21)2023 Oct 27.
Artículo en Inglés | MEDLINE | ID: mdl-37958223

RESUMEN

This study aims to evaluate the abdominal aortic atherosclerotic plaque index (API)'s predictive role in patients with pre-operatively or post-operatively developed chronic kidney disease (CKD) treated with robot-assisted partial nephrectomy (RAPN) for renal cell carcinoma (RCC). One hundred and eighty-three patients (134 with no pre- and post-operative CKD (no CKD) and 49 with persistent or post-operative CKD development (post-op CKD)) who underwent RAPN between January 2019 and January 2022 were deemed eligible for the analysis. The API was calculated using dedicated software by assessing the ratio between the CT scan atherosclerotic plaque volume and the abdominal aortic volume. The ROC regression model demonstrated the influence of API on CKD development, with an increasing effect according to its value (coefficient 0.13; 95% CI 0.04-0.23; p = 0.006). The Model 1 multivariable analysis of the predictors of post-op CKD found that the following are independently associated with post-op CKD: Charlson Comorbidity Index (OR 1.31; p = 0.01), last follow-up (FU) Δ%eGFR (OR 0.95; p < 0.01), and API ≥ 10 (OR 25.4; p = 0.01). Model 2 showed API ≥ 10 as the only factor associated with CKD development (OR 25.2; p = 0.04). The median follow-up was 22 months. Our results demonstrate API to be a strong predictor of post-operative CKD, allowing the surgeon to tailor the best treatment for each patient, especially in those who might be at higher risk of CKD.

11.
Minerva Urol Nephrol ; 75(3): 366-373, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-36383183

RESUMEN

BACKGROUND: Since before the COVID-19 pandemic, hospital-acquired infections (HAIs) represented a global healthcare crisis. Few studies suggested that COVID-19-related basic hygiene measures (BHM) could lower HAIs rates, reaching inconclusive results. The aim of this study was to investigate the hypothetical benefit on HAIs rate of COVID-19-enhanced BHM systematic introduction after major elective urological surgery. METHODS: Since the pandemic began, our hospital has implemented BHM to limit the spread of COVID-19. We compared patients operated in the pre-COVID-19 era (no-BHM period) with those operated after the pandemic started (BHM period). Outcomes were the incidence of HAIs and postoperative complications, and the length of hospital stay (LOS). Two balanced groups were generated by propensity score 1:1 matching. RESULTS: Of 1053 major urological interventions, 604 were performed in the no-BHM period, and 449 in the BHM period. After matched analysis, the comparison groups consisted of 310 patients each. Of 107 recorded HAIs, 43 occurred during the BHM period (13.9%), and 64 during the no-BHM period (20.7%), with a statistically significant difference in multivariable analysis (OR 0.5 [95% CI 0.3-0.8], P=0.004). Postoperative complications rate was significantly lower in the BHM period than in the no-BHM period (29.0% versus 36.5%, OR 0.6 [95% CI 0.4-0.9], P=0.01). The LOS differed significantly between BHM and no-BHM periods: a median of 5 (5-8) days versus 6 (5-8), respectively (P<0.001). CONCLUSIONS: The risk of infections, postoperative complications, and prolonged LOS after major urological surgery was significantly reduced with the systematic introduction of COVID-19-related BHM, their application could, therefore, be prolonged with lasting benefits.


Asunto(s)
COVID-19 , Infección Hospitalaria , Humanos , Pandemias , Análisis por Apareamiento , Complicaciones Posoperatorias , Higiene
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