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1.
BJU Int ; 130(1): 43-53, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-34878715

RESUMEN

OBJECTIVES: To test the feasibility of randomisation to radical prostatectomy (RP) plus pelvic lymphadenectomy in addition to standard-of-care (SOC) systemic therapy in men with newly diagnosed oligo-metastatic prostate cancer. PATIENTS AND METHODS: A prospective, randomised, non-blinded, feasibility clinical trial with an embedded QuinteT Recruitment Intervention (QRI) to optimise recruitment was conducted in nine nationwide tertiary care centres undertaking high-volume robotic surgery. We aimed to randomise 50 men with synchronous oligo-metastatic prostate cancer within an 18-month recruitment period to SOC systemic therapy vs SOC plus RP (intervention arm). The main outcome measures were: ability to randomise patients, optimised by a QRI; EuroQoL five Dimensions five Levels (EQ-5D-5L) questionnaires to capture quality-of-life (QoL) data at baseline and 3 months post-randomisation; routine clinicopathological assessment to capture adverse events and prostate-specific antigen in both arms, plus standard perioperative parameters in the surgical arm. RESULTS: A total of 51 men were randomised within 14 months (one was subsequently deemed ineligible), with 60-83% accrual rate in centres that recruited at least two patients. All patients completed the trial follow-up; one patient in the intervention arm subsequently did not undergo the surgical intervention and one in the SOC arm refused all therapies. The QRI positively impacted recruitment. QoL data showed similarly high functioning in both study arms. Surgery for men with oligo-metastatic prostate cancer was found to be safe and had similar impact on early functional outcomes as surgery for standard indication. CONCLUSION: It is feasible to randomise men with synchronous oligo-metastatic prostate cancer to a surgical intervention in addition to standard systemic therapies. While surgery appeared safe with no substantial impact on QoL in this feasibility study, a large randomised controlled trial is now warranted to examine treatment effectiveness of this additional component in the multimodality management of oligo-metastatic prostate cancer.


Asunto(s)
Neoplasias de la Próstata , Calidad de Vida , Estudios de Factibilidad , Humanos , Masculino , Estudios Prospectivos , Prostatectomía/métodos , Neoplasias de la Próstata/patología , Resultado del Tratamiento
2.
JAMA ; 327(21): 2092-2103, 2022 06 07.
Artículo en Inglés | MEDLINE | ID: mdl-35569079

RESUMEN

Importance: Robot-assisted radical cystectomy is being performed with increasing frequency, but it is unclear whether total intracorporeal surgery improves recovery compared with open radical cystectomy for bladder cancer. Objectives: To compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy. Design, Setting, and Participants: Randomized clinical trial of patients with nonmetastatic bladder cancer recruited at 9 sites in the UK, from March 2017-March 2020. Follow-up was conducted at 90 days, 6 months, and 12 months, with final follow-up on September 23, 2021. Interventions: Participants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169). Main Outcomes and Measures: The primary outcome was the number of days alive and out of the hospital within 90 days of surgery. There were 20 secondary outcomes, including complications, quality of life, disability, stamina, activity levels, and survival. Analyses were adjusted for the type of diversion and center. Results: Among 338 randomized participants, 317 underwent radical cystectomy (mean age, 69 years; 67 women [21%]; 107 [34%] received neoadjuvant chemotherapy; 282 [89%] underwent ileal conduit reconstruction); the primary outcome was analyzed in 305 (96%). The median number of days alive and out of the hospital within 90 days of surgery was 82 (IQR, 76-84) for patients undergoing robotic surgery vs 80 (IQR, 72-83) for open surgery (adjusted difference, 2.2 days [95% CI, 0.50-3.85]; P = .01). Thromboembolic complications (1.9% vs 8.3%; difference, -6.5% [95% CI, -11.4% to -1.4%]) and wound complications (5.6% vs 16.0%; difference, -11.7% [95% CI, -18.6% to -4.6%]) were less common with robotic surgery than open surgery. Participants undergoing open surgery reported worse quality of life vs robotic surgery at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores, -0.07 [95% CI, -0.11 to -0.03]; P = .003) and greater disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores, 0.48 [95% CI, 0.15-0.73]; P = .003) and at 12 weeks (difference in WHODAS 2.0 scores, 0.38 [95% CI, 0.09-0.68]; P = .01); the differences were not significant after 12 weeks. There were no statistically significant differences in cancer recurrence (29/161 [18%] vs 25/156 [16%] after robotic and open surgery, respectively) and overall mortality (23/161 [14.3%] vs 23/156 [14.7%]), respectively) at median follow-up of 18.4 months (IQR, 12.8-21.1). Conclusions and Relevance: Among patients with nonmetastatic bladder cancer undergoing radical cystectomy, treatment with robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy resulted in a statistically significant increase in days alive and out of the hospital over 90 days. However, the clinical importance of these findings remains uncertain. Trial Registration: ISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410.


Asunto(s)
Cistectomía , Procedimientos Quirúrgicos Robotizados , Robótica , Neoplasias de la Vejiga Urinaria , Derivación Urinaria , Anciano , Cistectomía/efectos adversos , Cistectomía/métodos , Cistectomía/mortalidad , Femenino , Humanos , Masculino , Morbilidad , Recurrencia Local de Neoplasia , Complicaciones Posoperatorias/etiología , Calidad de Vida , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/mortalidad , Resultado del Tratamiento , Neoplasias de la Vejiga Urinaria/mortalidad , Neoplasias de la Vejiga Urinaria/patología , Neoplasias de la Vejiga Urinaria/cirugía , Derivación Urinaria/efectos adversos , Derivación Urinaria/métodos , Derivación Urinaria/mortalidad
3.
J Contemp Dent Pract ; 23(11): 1122-1127, 2022 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-37073935

RESUMEN

AIM: To assess the push-out bond strength and tubular penetration of resin-based and bioceramic sealers after employing two collagen cross-linking agents, namely, cashew nut shell liquid (CNSL) and epigallocatechin-3-gallate (EGCG) on sodium hypochlorite treated root canal dentin. MATERIALS AND METHODS: Fifty human permanent mandibular premolars selected were decoronated at CEJ, this was followed by cleaning and shaping protocols, root canals were enlarged up to 20 sizes with 6% taper and were randomly divided into the following 5 groups with 10 samples each based on the cross-linking agent and the sealer: • Group I: Irrigation with saline (control). • Group II: Irrigation with cashew nut shell liquid followed by bioceramic sealer obturation. • Group III: Irrigation with cashew nut shell liquid followed by resin-based sealer obturation. • Group IV: Irrigation with EGCG followed by bioceramic sealer obturation. • Group V: Irrigation with EGCG followed by resin-based sealer obturation. Five specimens in each group were evaluated for push-out bond strength with the universal testing machine while the remaining five specimens in each group were evaluated for depth of sealer penetration by a scanning electron microscope (SEM). The data was recorded, tabulated, and statistically analyzed. RESULTS: The push-out bond strength was found to be maximum in the apical region in all the five groups followed by the middle third and coronal region. The maximum push-out bond strength was seen in group II followed by groups III and IV, and least in group V. The mean depth of tubular penetration of sealers was found to be effective in the coronal portion followed by the middle third while the apical third region showed the least depth penetration of sealers into the tubules. The maximum penetration of sealers was revealed in group V followed by groups III and IV, and least in group II. CONCLUSION: Within the limitations of this study, it can be concluded that push-out bond strength was found to the maximum in specimens irrigated with cashew nut shell liquid and obturated with bioceramic sealer. The maximum push-out bond strength was seen in the apical third of all root canals followed by the middle and coronal region. The scanning microscopic analysis revealed maximum mean tubular penetration in the coronal portion followed by the middle third and apical third. A greater penetration was seen in specimens irrigated with EGCG and obturated with hybrid sealer. CLINICAL SIGNIFICANCE: Selection of sealers plays a pivotal role in the success of endodontic therapy. Leakage-related issues can compromise the bond strength enhancing the bond strength can be achieved through the addition of cross-linking agents.


Asunto(s)
Materiales de Obturación del Conducto Radicular , Humanos , Dentina , Resinas Epoxi , Proyectos de Investigación , Materiales de Obturación del Conducto Radicular/química , Tratamiento del Conducto Radicular
4.
BJU Int ; 127(6): 676-686, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-32985121

RESUMEN

OBJECTIVES: To report on the methods, peri-operative outcomes and histopathological concordance between frozen and final section from the NeuroSAFE PROOF feasibility study (NCT03317990). PATIENTS AND METHODS: Between May 2018 and March 2019, 49 patients at two UK centres underwent robot-assisted radical prostatectomy (RARP). Twenty-five patient were randomized to NeuroSAFE RARP (intervention arm) and 24 to standard RARP (control arm). Frozen section was compared to final paraffin section margin assessment in the 25 patients in the NeuroSAFE arm. Operation timings and complications were collected prospectively in both arms. RESULTS: Fifty neurovascular bundles (NVBs) from 25 patients in the NeuroSAFE arm were analysed. When analysed by each pathological section (n = 250, average five per side), we noted a sensitivity of 100%, a specificity of 99.2%, and an area under the curve (AUC) of 0.994 (95% confidence interval [CI] 0.985 to 1; P ≤0.001). On an NVB basis (n = 50), sensitivity was 100%, specificity was 92.7%, and the AUC was 0.963 (95% CI 0.914 to 1; P ≤0.001). NeuroSAFE RARP lasted a mean of 3 h 16 min (knife to skin to off table, 95% CI 3 h 2 min-3 h 30 min) compared to 2 h 4 min (95% CI 2 h 2 min-2 h 25 min; P ≤0.001) for standard RARP. There was no morbidity associated with the additional length of operating time on in the NeuroSAFE arm. CONCLUSION: This feasibility study demonstrates the safety, reproducibility and excellent histopathological concordance of the NeuroSAFE technique in the NeuroSAFE PROOF trial. Although the technique increases the duration of RARP, this does not cause short-term harm. Confirmation of feasibility has led to the opening of the fully powered NeuroSAFE PROOF randomized controlled trial, which is currently under way at four sites in the UK.


Asunto(s)
Secciones por Congelación , Prostatectomía/métodos , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/cirugía , Procedimientos Quirúrgicos Robotizados , Adulto , Anciano , Estudios de Factibilidad , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Método Simple Ciego , Resultado del Tratamiento
5.
BJU Int ; 127(6): 729-741, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33185026

RESUMEN

OBJECTIVE: Coronavirus disease-19 (COVID-19) pandemic caused delays in definitive treatment of patients with prostate cancer. Beyond the immediate delay a backlog for future patients is expected. The objective of this work is to develop guidance on criteria for prioritisation of surgery and reconfiguring management pathways for patients with non-metastatic prostate cancer who opt for surgical treatment. A second aim was to identify the infection prevention and control (IPC) measures to achieve a low likelihood of coronavirus disease 2019 (COVID-19) hazard if radical prostatectomy (RP) was to be carried out during the outbreak and whilst the disease is endemic. METHODS: We conducted an accelerated consensus process and systematic review of the evidence on COVID-19 and reviewed international guidance on prostate cancer. These were presented to an international prostate cancer expert panel (n = 34) through an online meeting. The consensus process underwent three rounds of survey in total. Additions to the second- and third-round surveys were formulated based on the answers and comments from the previous rounds. The Consensus opinion was defined as ≥80% agreement and this was used to reconfigure the prostate cancer pathways. RESULTS: Evidence on the delayed management of patients with prostate cancer is scarce. There was 100% agreement that prostate cancer pathways should be reconfigured and measures developed to prevent nosocomial COVID-19 for patients treated surgically. Consensus was reached on prioritisation criteria of patients for surgery and management pathways for those who have delayed treatment. IPC measures to achieve a low likelihood of nosocomial COVID-19 were coined as 'COVID-19 cold' sites. CONCLUSION: Reconfiguring management pathways for patients with prostate cancer is recommended if significant delay (>3-6 months) in surgical management is unavoidable. The mapped pathways provide guidance for such patients. The IPC processes proposed provide a framework for providing RP within an environment with low COVID-19 risk during the outbreak or when the disease remains endemic. The broader concepts could be adapted to other indications beyond prostate cancer surgery.


Asunto(s)
COVID-19/epidemiología , Vías Clínicas , Pandemias , Prostatectomía , Neoplasias de la Próstata/cirugía , Técnica Delphi , Asignación de Recursos para la Atención de Salud , Humanos , Control de Infecciones , Masculino , SARS-CoV-2 , Tiempo de Tratamiento
6.
BJU Int ; 126(2): 225-234, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32383520

RESUMEN

OBJECTIVES: To determine the risk of COVID-19 transmission during minimally invasive surgical (MIS) procedures METHODS: Surgical society statements regarding the risk of COVID transmission during MIS procedures were reviewed. In addition, the available literature on COVID-19 and other viral transmission in CO2 pneumoperitoneum, as well as the presence of virus in the plume created by electrocautery during MIS was reviewed. The society recommendations were compared to the available literature on the topic to create our review and recommendations to mitigate COVID-19 transmission. RESULTS: The recommendations promulgated by various surgical societies evolved over time as more information became available on COVID-19 transmission. Review of the available literature on the presence of COVID-19 in CO2 pneumoperitoneum was inconclusive. There is no clear evidence of the presence of COVID-19 in plume created by electrocautery. Technologies to reduce CO2 pneumoperitoneum release into the operating room as well as filter viral particles are available and should reduce the exposure risk to operating room personnel. CONCLUSION: There is no clear evidence of COVID-19 virus in the CO2 used during MIS procedures or in the plume created by electrocautery. Until the presence or absence of COVID-19 viral particles has been clearly established, measures to mitigate CO2 and surgical cautery plume release into the operating room should be performed. Further study on the presence of COVID-19 in MIS pneumoperitoneum and cautery plume is needed.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/transmisión , Transmisión de Enfermedad Infecciosa/prevención & control , Control de Infecciones/normas , Quirófanos/normas , Pandemias , Neumonía Viral/transmisión , Procedimientos Quirúrgicos Robotizados/normas , COVID-19 , Infecciones por Coronavirus/epidemiología , Salud Global , Humanos , Neumonía Viral/epidemiología , SARS-CoV-2
7.
BMC Urol ; 20(1): 81, 2020 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-32611411

RESUMEN

BACKGROUND: Partial ablation of the prostate using high-intensity focussed ultrasound (HIFU-PA) is a treatment option for localised prostate cancer. When local recurrence occurs, salvage robot-assisted radical prostatectomy is a treatment option for selected patients, but there is a paucity of data on the peri-operative safety, functional and oncologic outcomes of sRARP.. The objective of this study was therefore to describe peri-operative safety, functional and early oncologic outcomes following salvage robot-assisted radical prostatectomy (sRARP) for local recurrence after HIFU-PA. METHODS: Retrospective analysis of a prospective database of 53 consecutive men who underwent sRARP after HIFU-PA from 2012 to 2018. Continence and erectile-function were reported pre-HIFU, pre-sRARP, 3-months post-sRARP and 12-months post-sRARP. Complications, PSMs and need for subsequent ADT/radiotherapy were assessed. RESULTS: 45 men were suitable for inclusion and had sufficient data for analyses. Median duration from HIFU to sRARP was 30.0 months and median follow-up post-sRARP was 17.7 months. Median age, PSA and ISUP group were 63.0 yrs., 7.2 ng/mL and 2; 88.9% were cT2. Median operative-console time, blood loss and hospital stay were 140 min, 200 ml and 1 day respectively. Clavien-Dindo grade 1, 2 and 3 complications < 90 days occurred in 8.9, 6.7 and 2.2%; late (>90d) complications occurred in 13.2%. At sRARP pathology, ISUP 3-5 occurred in 51.1%, pT3a/b in 64.5%, and PSMs in 44.4% (37.5% for pT2, 48.3% for pT3). Of men with > 3-months follow-up after sRARP, 26.3% underwent adjuvant radiotherapy/ADT for residual disease or adverse pathologic features; 5.3% experienced BCR requiring salvage ADT/radiotherapy. Freedom from ADT/radiotherapy was 66.7% at 12-months. Pad-free rates were 100% pre-HIFU, 95.3% post-HIFU, 29.4% 3-months post-sRARP, and 65.5% 12-months post-sRARP. Median IIEF-5 scores pre-HIFU, post-HIFU, 3- and 12-months post-sRARP were 23.5, 16, 5 and 5, respectively. Potency rates were 81.8, 65.5, 0 and 0%, respectively. Bilateral/unilateral nerve sparing were feasible in 7%/22%. CONCLUSION: Salvage RARP was safe with acceptable but sub-optimal continence and poor sexual-function and poor oncologic outcomes. One in three men required additional treatment within 12-months. This information may aid men and urologists with treatment selection and counselling regarding primary HIFU-PA vs primary RARP and when considering salvage RARP.


Asunto(s)
Ultrasonido Enfocado de Alta Intensidad de Ablación , Recurrencia Local de Neoplasia/cirugía , Prostatectomía/métodos , Neoplasias de la Próstata/cirugía , Procedimientos Quirúrgicos Robotizados , Anciano , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Terapia Recuperativa , Factores de Tiempo , Resultado del Tratamiento
8.
Prostate ; 79(7): 768-777, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30807665

RESUMEN

BACKGROUND: Over 1 million men are diagnosed with prostate cancer each year worldwide, with a wide range of research programs requiring access to patient tissue samples for development of improved diagnoses and treatments. A random sampling of prostate tissue is sufficient for certain research studies; however, there is growing research need to target areas of the aggressive tumor as fresh tissue. Here we set out to develop a new pathway "PEOPLE: PatiEnt prOstate samPLes for rEsearch" to collect high-quality fresh tissue for research use, using magnetic resonance imaging (MRI) to target areas of tumor and benign tissue. METHODS: Prostate tissue was sampled following robotic radical prostatectomy, using MRI data to target areas of benign and tumor tissue. Initially, 25 cases were sampled using MRI information from clinical notes. A further 59 cases were sampled using an optimized method that included specific MRI measurements of tumor location along with additional exclusion criteria. All cases were reviewed in batches with detailed clinical and histopathological data recorded. For one subset of samples, DNA was extracted and underwent quality control. Ex vivo culture was carried out using the gelatin sponge method for an additional subset. RESULTS: Tumor was successfully fully or partially targeted in 64% of the initial cohort and 70% of the optimized cohort. DNA of high quality and concentration was isolated from 39 tumor samples, and ex vivo culture was successfully carried out in three cases with tissue morphology, proliferation, and apoptosis remaining comparable before and after 72 hours culture. CONCLUSION: Here we report initial data from the PEOPLE pathway; using a method for targeting areas of tumor within prostate samples using MRI. This method operates alongside the standard clinical pathway and minimizes additional input from surgical, radiological, and pathological teams, while preserving surgical margins and diagnostic tissue.


Asunto(s)
Imagen por Resonancia Magnética , Próstata/diagnóstico por imagen , Próstata/patología , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patología , Manejo de Especímenes/métodos , Humanos , Masculino , Próstata/cirugía , Prostatectomía , Neoplasias de la Próstata/cirugía
9.
Br J Cancer ; 120(7): 771, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30808994

RESUMEN

Since the publication of this paper, the authors noticed that Amar Ahmad was not credited as contributing equally to the paper. He should be considered as a joint first author with Lorenzo Dutto. In addition, the author Ashwin Sridhar was incorrectly listed as Ashwin Shridhar, and the author Gregory L. Shaw was incorrectly listed as Gregory Shaw. The correct names are listed above.

10.
J Urol ; 201(6): 1134-1143, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-30730409

RESUMEN

PURPOSE: We describe the pathological characteristics of recurrence following high intensity focused ultrasound partial ablation in men treated with salvage robot-assisted radical prostatectomy. We assessed the sensitivity of magnetic resonance imaging before salvage robot-assisted radical prostatectomy in these men. MATERIALS AND METHODS: A total of 35 men underwent salvage robot-assisted radical prostatectomy after high intensity focused ultrasound partial ablation from 2012 to 2018. We compared clinicopathological characteristics before ultrasound and before salvage prostatectomy after ultrasound to histopathology on salvage prostatectomy. We assessed infield recurrence, out of field disease, positive surgical margins and magnetic resonance imaging sensitivity before salvage robot-assisted radical prostatectomy. RESULTS: Before high intensity focused ultrasound 55.9% of men had multifocal disease and 47.1% had Gleason 3 + 3 disease outside the treatment field. Median time to salvage prostatectomy was 16 months (IQR 11-26). Indications for salvage prostatectomy were infield recurrence in 55.8% of cases, out of field recurrence in 20.6%, and infield and out of field recurrence in 23.5%. On salvage prostatectomy histopathology revealed significant cancer, defined as ISUP (International Society of Urological Pathology) 2 or greater, infield in 97.1% of cases, out of field in 81.3%, and infield and out of field in 79.4%. Of the cases 82.4% were adversely reclassified at salvage prostatectomy compared to 67.6% before ultrasound. The positive surgical margin rate was 40.0%. Of the positive margins 84.6% were in the region of previous ultrasound despite wide excision, including pT2 in 28.6%, pT3 in 47.6% and size 3 mm or greater, pT3 or multifocal (ie significant) in 31.4%. After ultrasound the sensitivity of magnetic resonance imaging for infield and out of field recurrence was 81.8% and 60.7%, respectively. CONCLUSIONS: Salvage robot-assisted radical prostatectomy may confer a higher risk of positive surgical margins, upgrading and up-staging than primary robot-assisted radical prostatectomy. High intensity focused ultrasound carries a risk of recurrence inside and outside the ablation zone. This information may inform salvage surgical planning and patient counseling regarding the choice of initial therapy and salvage treatment after high intensity focused ultrasound.


Asunto(s)
Ultrasonido Enfocado de Alta Intensidad de Ablación , Imagen por Resonancia Magnética , Recurrencia Local de Neoplasia/diagnóstico por imagen , Recurrencia Local de Neoplasia/patología , Prostatectomía , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patología , Anciano , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/cirugía , Prostatectomía/métodos , Neoplasias de la Próstata/cirugía , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados , Terapia Recuperativa , Sensibilidad y Especificidad
11.
Br J Cancer ; 119(12): 1445-1450, 2018 12.
Artículo en Inglés | MEDLINE | ID: mdl-30478408

RESUMEN

BACKGROUND: Active surveillance is recommended for insignificant prostate cancer (PCa). Tools exist to identify suitable candidates using clinical variables. We aimed to develop and validate a novel risk score (NRS) predicting which patients are harbouring insignificant PCa. METHODS: We used prospectively collected data from 8040 consecutive unscreened patients who underwent radical prostatectomy between 2006 and 2016. Of these, data from 2799 patients with Gleason 3 + 3 on biopsy were used to develop a multivariate model predicting the presence of insignificant PC at radical prostatectomy (ERSPC updated definition3: Gleason 3 + 3 only, index tumour volume < 1.3 cm3 and total tumour volume < 2.5 cm3). This was used to develop a novel risk score (NRS) which was validated in an equivalent independent cohort (n = 441). We compared the accuracy of existing predictive tools and the NRS in these cohorts. RESULTS: The NRS (incorporating PSA, prostate volume, age, clinical T Stage, percent and number of positive biopsy cores) outperformed pre-existing predictive tools in derivation and validation cohorts (AUC 0.755 and 0.76, respectively). Selection bias due to analysis of a surgical cohort is acknowledged. CONCLUSIONS: The advantage of the NRS is that it can be tailored to patient characteristics and may prove to be valuable tool in clinical decision-making.


Asunto(s)
Neoplasias de la Próstata/diagnóstico , Anciano , Toma de Decisiones Clínicas , Estudios de Cohortes , Humanos , Masculino , Persona de Mediana Edad , Antígeno Prostático Específico/sangre , Prostatectomía , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/cirugía , Riesgo
12.
BJU Int ; 121(4): 632-639, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29124853

RESUMEN

OBJECTIVE: To assess the cumulative effect of an enhanced recovery after surgery (ERAS) pathway and minimally invasive robot-assisted radical cystectomy with intracorporeal urinary diversion (iRARC) in comparison with open radical cystectomy (ORC) on length of hospital stay (LOS) and peri-operative outcomes. MATERIALS AND METHODS: Between February 2009 and October 2017, 304 radical cystectomy cases were performed at a single institution (ORC, n = 54; robot-assisted radical cystectomy [RARC], n = 250). Data were prospectively collected. We identified 45 consecutive ORC cases performed without ERAS before the commencement of the RARC programme (Cohort A), 50 consecutive iRARC cases performed without ERAS (Cohort B) and 40 iRARC cases with ERAS (Cohort C). The primary outcome measure was LOS, while secondary outcome measures included peri-operative 90-day complications and readmission rate. Complications were accessed using the Clavien-Dindo system. RESULTS: Patients in all cohorts were evenly matched with regard to age, sex, body mass index, neoadjuvant treatment, tumour stage, lymph node yield, previous pelvic radiotherapy and surgery, peri-operative anaemia, as well as physiological state. Patients who underwent iRARC with ERAS had a significantly higher American Society of Anesthesiologists score (III-IV) and were more likely to receive neobladder reconstruction. The median (interquartile range) LOS was shorter in the iRARC with ERAS group (7 [6-10]) days than in the iRARC without ERAS group (11 [8-15]) days and the ORC group (17 [14-21] days). In a propensity score-matched cohort of patients who underwent iRARC, patients who followed the ERAS pathway had significantly lower 90-day readmission rates. Additionally, implementing ERAS in an iRARC cohort resulted in a significantly lower 90-day all (P < 0.001) and gastrointestinal-related complications (P = 0.001). The ERAS pathway and younger patients were independently associated with an LOS of ≤10 days on multinomial logistic regression. CONCLUSION: A comprehensive ERAS programme can significantly reduce LOS in patients undergoing iRARC without increasing 90-day readmission rates. An ERAS programme can augment the benefits of iRARC in improving peri-operative outcomes. In studies comparing ORC and RARC, the presence or absence of an ERAS programme will be a confounding factor and only level 1 evidence can be interpreted reliably.


Asunto(s)
Cistectomía , Procedimientos Quirúrgicos Robotizados , Adulto , Anciano , Anciano de 80 o más Años , Cistectomía/efectos adversos , Cistectomía/métodos , Cistectomía/mortalidad , Cistectomía/estadística & datos numéricos , Femenino , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Puntaje de Propensión , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/mortalidad , Procedimientos Quirúrgicos Robotizados/estadística & datos numéricos , Resultado del Tratamiento , Neoplasias de la Vejiga Urinaria/cirugía
13.
Curr Urol Rep ; 18(8): 58, 2017 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-28647793

RESUMEN

PURPOSE OF REVIEW: There has been a rapid and widespread adoption of the robotic surgical system with a lag in the development of a comprehensive training and credentialing framework. A literature search on robotic surgical training techniques and benchmarks was conducted to provide an evidence-based road map for the development of a robotic surgical skills for the novice robotic surgeon. RECENT FINDINGS: A structured training curriculum is suggested incorporating evidence-based training techniques and benchmarks for progress. This usually involves sequential progression from observation, case assisting, acquisition of basic robotic skills in the dry and wet lab setting along with achievement of individual and team-based non-technical skills, modular console training under supervision, and finally independent practice. Robotic surgical training must be based on demonstration of proficiency and safety in executing basic robotic skills and procedural tasks prior to independent practice.


Asunto(s)
Competencia Clínica/normas , Curriculum/normas , Procedimientos Quirúrgicos Robotizados/educación , Simulación por Computador , Humanos , Laparoscopía/educación , Laparoscopía/normas , Procedimientos Quirúrgicos Robotizados/normas
14.
Curr Urol Rep ; 18(9): 71, 2017 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-28718165

RESUMEN

PURPOSE OF REVIEW: A variety of different surgical techniques are thought to impact on urinary continence (UC) recovery in patients undergoing robot assisted radical prostatectomy (RARP) for prostate cancer. Herein, we review current evidence and propose a composite evidence-based technique to optimize UC recovery after RARP. RECENT FINDINGS: A literature search on studies reporting on surgical techniques to improve early continence recovery post robotic prostatectomy was conducted on PubMed and EMBASE. The available data from studies ranging from randomized control trials to retrospective cohort studies suggest that minimizing damage to the internal and external urinary sphincters and their neural supply, maximal sparing of urethral length, creating a secure vesicourethral anastomosis, and providing anterior and posterior myo- fascio-ligamentous support to the anastomosis can improve early UC recovery post RARP. A composite evidence-based surgical technique incorporating the above principles could optimize early UC recovery post RARP. Evidence from randomized studies is required to prove benefit.


Asunto(s)
Prostatectomía , Neoplasias de la Próstata/cirugía , Procedimientos Quirúrgicos Robotizados , Incontinencia Urinaria/cirugía , Humanos , Masculino , Neoplasias de la Próstata/complicaciones , Recuperación de la Función , Incontinencia Urinaria/etiología
15.
Curr Urol Rep ; 18(11): 89, 2017 Sep 23.
Artículo en Inglés | MEDLINE | ID: mdl-28942572

RESUMEN

Use of robot-assisted surgery is increasing since its advent in the 1990s. Robotic surgical training is the subject of much interest. Robotic technology would seem to facilitate training allowing more rapid attainment of competence. The safety and success of a particular surgical team depends on adequacy of training of its members. A learning curve is a way of describing the changes observed in surgical outcomes with increasing experience of the surgeon and can be used to plan training programs. The majority of published papers regarding learning curves are retrospective with small numbers of surgeons with different levels of experience comparing a variety of different outcomes. In this review, we describe the published literature on learning curves in robotic urological surgery, with the aim of offering a guide to both experienced and naïve surgeons who plan to learn new robotic procedure.


Asunto(s)
Cistectomía/instrumentación , Curva de Aprendizaje , Nefrectomía/instrumentación , Procedimientos Quirúrgicos Robotizados/educación , Cistectomía/métodos , Humanos , Nefrectomía/métodos , Estudios Retrospectivos , Entrenamiento Simulado , Realidad Virtual
17.
J Sex Med ; 13(3): 435-43, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-26944466

RESUMEN

INTRODUCTION: Recovery of baseline erectile function (EF) after robotic radical prostatectomy in men with high-risk prostate cancer is under-reported. Published studies have selectively reported on low-risk disease using non-validated and poorly defined thresholds for EF recovery. AIM: To assess return to baseline EF in men after robotic radical prostatectomy for high-risk prostate cancer. MATERIALS: Five hundred thirty-one men underwent robotic radical prostatectomy for high-risk prostate cancer from February 2010 through July 2014. Pre- and postoperative EF was prospectively assessed using the International Index of Erectile Dysfunction (IIEF-5) questionnaire. Multivariate logistic regression analysis determined the effect of age, preoperative function, comorbidities, body mass index, prostate-specific antigen level, cancer stage or grade, nerve-sparing status, adjuvant therapy, and continence on EF return (defined as postoperative return to baseline EF with or without use of phosphodiesterase type 5 inhibitors). Kaplan-Meier analysis and log-rank test were used to analyze return over time. Mann-Whitney U-test was used to compare IIEF-5 scores. MAIN OUTCOME MEASURES: Pre- and postoperative EF was assessed using the IIEF-5 Sexual Health Inventory for Men at 3 months, 6 months, 1 year, 2 years, 3 years, and 4 years postoperatively. RESULTS: Overall, return of EF was seen in 23.5% of patients at 18 months. This was significantly increased in men no older than 60 years (P = .024), with a preoperative IIEF-5 score of at least 22 (P = .042), and after undergoing neurovascular bundle preservation (34.9% of patients, P < .001). There was no significant change in IIEF-5 scores from 3 to 36 months in patients who were treated with phosphodiesterase type 5 inhibitors in the non-neurovascular bundle preservation group (P = .87), although there was significant improvement in those receiving second- or third-line therapies (P = .042). Other than preoperative hypertension (P = .03), none of the other comorbidities predicted return of EF. CONCLUSION: In this study, 23.5% of men recovered to baseline EF. Of those who underwent bilateral neurovascular bundle preservation robotic radical prostatectomy, 70% recovered baseline EF; however, this accounted for only 9.6% of all patients. Only 4% of men who underwent non-neurovascular bundle preservation had baseline recovery with phosphodiesterase type 5 inhibitors up to 36 months. There was significant improvement after use of second- or third-line therapies, indicating the need for earlier institution of these treatment modalities.


Asunto(s)
Disfunción Eréctil/fisiopatología , Erección Peniana/fisiología , Prostatectomía , Neoplasias de la Próstata/fisiopatología , Neoplasias de la Próstata/cirugía , Procedimientos Quirúrgicos Robotizados , Adulto , Anciano , Biomarcadores de Tumor/sangre , Disfunción Eréctil/etiología , Disfunción Eréctil/psicología , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Erección Peniana/efectos de los fármacos , Inhibidores de Fosfodiesterasa 5/farmacología , Periodo Posoperatorio , Periodo Preoperatorio , Estudios Prospectivos , Antígeno Prostático Específico/sangre , Prostatectomía/efectos adversos , Neoplasias de la Próstata/sangre , Recuperación de la Función , Procedimientos Quirúrgicos Robotizados/efectos adversos , Encuestas y Cuestionarios , Factores de Tiempo
18.
J Med Syst ; 40(8): 187, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-27342107

RESUMEN

Electronic Health Record (EHR) use in India is generally poor, and structured clinical information is mostly lacking. This work is the first attempt aimed at evaluating unstructured text mining for extracting relevant clinical information from Indian clinical records. We annotated a corpus of 250 discharge summaries from an Intensive Care Unit (ICU) in India, with markups for diseases, procedures, and lab parameters, their attributes, as well as key demographic information and administrative variables such as patient outcomes. In this process, we have constructed guidelines for an annotation scheme useful to clinicians in the Indian context. We evaluated the performance of an NLP engine, Cocoa, on a cohort of these Indian clinical records. We have produced an annotated corpus of roughly 90 thousand words, which to our knowledge is the first tagged clinical corpus from India. Cocoa was evaluated on a test corpus of 50 documents. The overlap F-scores across the major categories, namely disease/symptoms, procedures, laboratory parameters and outcomes, are 0.856, 0.834, 0.961 and 0.872 respectively. These results are competitive with results from recent shared tasks based on US records. The annotated corpus and associated results from the Cocoa engine indicate that unstructured text mining is a viable method for cohort analysis in the Indian clinical context, where structured EHR records are largely absent.


Asunto(s)
Cuidados Críticos/estadística & datos numéricos , Minería de Datos/métodos , Registros Electrónicos de Salud/estadística & datos numéricos , Procesamiento de Lenguaje Natural , Alta del Paciente/estadística & datos numéricos , Factores de Edad , Técnicas y Procedimientos Diagnósticos , Humanos , India , Factores Sexuales , Factores Socioeconómicos
19.
BJU Int ; 116(5): 771-9, 2015 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-26033321

RESUMEN

OBJECTIVE: To describe a robot-assisted intracorporeal pyramid neobladder reconstruction technique and report operative and perioperative metrics, postoperative upper tract imaging, neobladder functional outcomes, and oncological outcomes. PATIENTS AND METHODS: In all, 20 patients (19 male and one female) with a mean (sd; range) age of 57.2 (12.4; 31.0-78.2) years underwent robot-assisted radical cystectomy (RARC). Most cases were ≤pT1 (17 patients) and the remaining three patients had muscle-invasive bladder cancer (MIBC) at RARC histopathology. Although half of the patients (10) actually had MIBC at transurethral resection histopathology. All patients underwent RARC, bilateral pelvic lymphadenectomy, and intracorporeal neobladder formation using a pyramid detubularised folding pouch configuration. RESULTS: The median estimated blood loss was 250 mL and operating time was 5.5 h. The mean (sd) number of lymph nodes removed was 16.5 (7.8) and median hospital stay was 10 days. Early postoperative complications included urinary tract infection (UTI) (four patients), ileus (four), diarrhoea and vomiting (three), postoperative collection (two), and blocked stent (one). Late postoperative complications included UTI (seven patients), neobladder stone (two), voiding Hem-o-Loc (two), neobladder leak (two), diarrhoea and vomiting (one), uretero-ileal stricture (one), vitamin B12 deficiency (one), and port-site hernia (one). There was no evidence of hydronephrosis in 18 patients with a median follow-up of 21.5 months. At 24 months, recurrence-free survival was 86% and overall survival was 100%. In all, 19 patients and 13 patients reported 6-month day time and night time continence, respectively. CONCLUSIONS: The pyramid neobladder is technically feasible using a robotic platform and provides satisfactory functional outcomes at median of 21.5 months.


Asunto(s)
Carcinoma de Células Transicionales/cirugía , Cistectomía , Complicaciones Posoperatorias/cirugía , Robótica , Neoplasias de la Vejiga Urinaria/cirugía , Derivación Urinaria , Carcinoma de Células Transicionales/patología , Carcinoma de Células Transicionales/fisiopatología , Cistectomía/métodos , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Tempo Operativo , Resultado del Tratamiento , Neoplasias de la Vejiga Urinaria/patología , Neoplasias de la Vejiga Urinaria/fisiopatología , Derivación Urinaria/métodos
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