RESUMEN
Cochlear implant today are an essential method of auditory rehabilitation in patients with severe to profound hearing loss. Due to the rapid development of implant technology the results have been markedly improved. Today about 80 % of patients can use the telephone and children achieve near to normal hearing and speech development. In consequence, more patients are candidates for a cochlear implant today including those with high frequency deafness and single sided deafness. However, today only 60,000 out of 1 Million CI-candidates in Germany have been implanted so far. In future multi modal universal auditory implants will provide combined electric-mechanical stimulation to make best use of the residual auditory hearing and the electrical stimulation of the auditory nerve. They allow a continuous adaptation of the stimulation strategy onto the given functional status of haircells and auditory nerve fibers especially in cases of progressive hearing loss. Brain computer interfaces will allow the automated fitting and adaptation to the acoustic scene by optimizing the signal processing for best possible auditory performance. Binaural hearing systems will improve directional hearing and speech perception in noise. Advanced implants are composed of individualized electrodes by additive manufacturing which can be inserted atraumaticly by a computer and robot assisted surgery. After insertion they automatically adept to the anatomy of the individual cochlear. These advanced implants are composed with additional integrated biological components for the preservation of residual hearing and regeneration of neural elements to improve the electrode nerve interface. This will allow to increase the number of electrical contacts as a major step towards the bionic ear. This will allow overcoming the principal limits of today's cochlear implant technology. Advanced care models will allow an easy way for the patient towards hearing preservation cochlear implantation under local anesthesia using minimal invasive high precision cochlear implant surgery. These implant systems will become a personal communicator with improved connectivity. Remote care and self-fitting will empower the patient to optimize his own hearing.
Asunto(s)
Implantación Coclear , Implantes Cocleares , Sordera , Percepción del Habla , Niño , Sordera/rehabilitación , Sordera/cirugía , Pérdida Auditiva de Alta Frecuencia , Humanos , Calidad de Vida , Percepción del Habla/fisiologíaRESUMEN
BACKGROUND: Lipegfilgrastim has been shown to be non-inferior to pegfilgrastim for reduction of the duration of severe neutropenia (DSN) in breast cancer patients. This open-label, non-inferiority study assessed the efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (NHL) at high risk for chemotherapy-induced neutropenia. PATIENT AND METHODS: One hundred and one patients (median age, 75 years) were randomized to lipegfilgrastim or pegfilgrastim (6 mg/cycle) during six cycles of R-CHOP21. RESULTS: Lipegfilgrastim was non-inferior to pegfilgrastim for the primary efficacy endpoint, reduction of DSN in cycle 1. In the per-protocol population, mean (standard deviation) DSN was 0.8 (0.92) and 0.9 (1.11) days in the two groups, respectively; the adjusted mean difference between groups was - 0.3 days (95% confidence interval, - 0.70 to 0.19). Non-inferiority was also demonstrated in the intent-to-treat population. The incidence of severe neutropenia in cycle 1 was 51% (21/41) in the lipegfilgrastim group and 52% (23/44) in the pegfilgrastim group. Very severe neutropenia (ANC < 0.1 × 109/L) in cycle 1 was reported by 5 (12%) patients in the lipegfilgrastim group and 8 (18%) patients in the pegfilgrastim group. However, over all cycles, febrile neutropenia (strict definition) was reported by only 1 (2%) patient in each treatment group (during cycle 1 in the lipegfilgrastim group and cycle 6 in the pegfilgrastim group). The mean time to absolute neutrophil count recovery (defined as ≥ 2.0 × 109/L) was 8.3 and 9.4 days in the two groups, respectively. Serious adverse events occurred in 46% of patients in each group; none were considered treatment-related. Eight patients died during the study (2 in the lipegfilgrastim group, 5 in the pegfilgrastim group, and 1 who died before starting study treatment). No deaths occurred during the treatment period, and all were considered to be related to the underlying disease. CONCLUSIONS: This study shows lipegfilgrastim to be non-inferior to pegfilgrastim for the reduction of DSN in elderly patients with aggressive B cell NHL receiving myelosuppressive chemotherapy, with a comparable safety profile. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT02044276; EudraCT number 2013-001284-23.
Asunto(s)
Filgrastim/uso terapéutico , Linfoma no Hodgkin/tratamiento farmacológico , Neutropenia/inducido químicamente , Neutrófilos/metabolismo , Polietilenglicoles/uso terapéutico , Anciano , Femenino , Filgrastim/farmacología , Factor Estimulante de Colonias de Granulocitos/uso terapéutico , Humanos , Incidencia , Polietilenglicoles/farmacologíaRESUMEN
In multivariate analysis, GS of the regular prostatectomy specimen was the only statistically significant parameter for pT2R1 prostate cancer.
RESUMEN
Twenty years ago, cochlear implants (CI) were indicated only in cases of profound hearing loss or complete deafness. While from today's perspective the technology was clumsy and provided patients with only limited speech comprehension in quiet scenarios, successive advances in CI technology and the consequent substantial hearing improvements over time have since then resulted in continuous relaxation of indication criteria toward residual hearing. While achievements in implant and processor electronics have been one key factor for the ever-improving hearing performance, development of electro-acoustic CI systems-together with atraumatic implantation concepts-has led to enormous improvements in patients with low-frequency residual hearing. Manufactures have designed special processors with integrated hearing aid components for this patient group, which are capable of conveying acoustic and electric stimulation. A further milestone in improvement of hearing in challenging listening environments was the adoption of signal enhancement algorithms and assistive listening devices from the hearing aid industry. This article gives an overview of the current state of the art in the abovementioned areas of CI technology.
Asunto(s)
Estimulación Acústica/instrumentación , Implantación Coclear/métodos , Implantes Cocleares/tendencias , Terapia por Estimulación Eléctrica/instrumentación , Pérdida Auditiva/rehabilitación , Espectrografía del Sonido/instrumentación , Estimulación Acústica/métodos , Estimulación Acústica/tendencias , Implantación Coclear/instrumentación , Implantación Coclear/tendencias , Terapia por Estimulación Eléctrica/métodos , Terapia por Estimulación Eléctrica/tendencias , Diseño de Equipo , Análisis de Falla de Equipo , Predicción , Humanos , Procesamiento de Señales Asistido por Computador/instrumentación , Espectrografía del Sonido/métodos , Espectrografía del Sonido/tendencias , Evaluación de la Tecnología BiomédicaRESUMEN
PURPOSE: Different blood parameters have shown to be associated with patient's oncological outcome. There is only limited knowledge about the prognostic relevance of routine blood parameters in patients undergoing radical cystectomy for transitional cell carcinoma (TCC). Therefore, we retrospectively analyzed the influence of preoperative C-reactive protein (CRP) and hemoglobin (Hb) levels on overall survival (OS) and cancer-specific survival (CSS). MATERIALS AND METHODS: Preoperative CRP and Hb levels were available in 664 patients who underwent RC due to TCC from 2004 to 2013 at our institution. More men than women (77 vs. 23 %) underwent surgery with a median age of 70 years (35-97). Median follow-up time was 24 months (max. 108). Outcome was analyzed using Kaplan-Meier method, log-rank test, and Cox regression models. RESULTS: Median CRP level was 0.5 mg/dl (0.1-28.3), and median Hb level was 13.4 g/dl (6.7-17.9). Patients with CRP value above the median died significantly earlier due to their disease than those with CRP below the median (median CSS 19 vs. 70 months; p < 0.001). Patients with preoperative Hb level below the median had significantly worse outcome than those with Hb level above the median (median CSS 25 vs. 78 months; p < 0.001). In multivariate analysis, CRP and Hb levels were independent prognostic parameters regarding CSS/OS (CRP p = 0.016/p = 0.004; Hb p = 0.006/p = 0.004, respectively). CONCLUSIONS: In our single-center study, preoperative CRP and Hb levels were found to be independent prognostic factors, indicating impaired outcome in patients undergoing RC for TCC. These findings could be used for individual risk stratification and optimization of therapeutic strategies.
Asunto(s)
Proteína C-Reactiva/análisis , Carcinoma de Células Transicionales/sangre , Carcinoma de Células Transicionales/cirugía , Cistectomía , Hemoglobinas/análisis , Neoplasias de la Vejiga Urinaria/sangre , Neoplasias de la Vejiga Urinaria/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Células Transicionales/mortalidad , Cistectomía/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Periodo Preoperatorio , Pronóstico , Estudios Retrospectivos , Tasa de Supervivencia , Neoplasias de la Vejiga Urinaria/mortalidadRESUMEN
PURPOSE: Lipegfilgrastim is a once-per-cycle, fixed-dose, glycoPEGylated recombinant granulocyte colony-stimulating factor (G-CSF) recently approved in Europe to reduce the duration of chemotherapy-induced neutropenia and incidence of febrile neutropenia in patients with cancer receiving chemotherapy. Bone pain-related (BPR) adverse events are commonly associated with G-CSF therapy. This post hoc analysis examined BPR treatment-emergent adverse events (TEAEs) in two comparative studies of lipegfilgrastim or pegfilgrastim in patients receiving chemotherapy. METHODS: A post hoc analysis was conducted using integrated data from two double-blind randomized studies in patients with breast cancer receiving docetaxel and doxorubicin and treated prophylactically with subcutaneous lipegfilgrastim 6 mg or pegfilgrastim 6 mg once per cycle. BPR TEAEs were defined as arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, noncardiac chest pain, and pain in extremity. Relationship of BPR TEAEs to study treatment or chemotherapy was also reported by the investigators. RESULTS: The analysis included 306 patients (lipegfilgrastim: n = 151; pegfilgrastim: n = 155). The proportion of patients experiencing BPR TEAEs was similar with lipegfilgrastim and pegfilgrastim (25.2 vs 21.9%, respectively), as was the proportion of patients experiencing BPR treatment-emergent adverse drug reactions (TEADRs) (18.5 vs 16.8%, respectively). No BPR TEADRs were serious, and none led to discontinuation. CONCLUSIONS: Nonsevere BPR TEAEs and TEADRs were observed in patients with breast cancer receiving chemotherapy and G-CSF; rates of BPR events were similar between lipegfilgrastim and pegfilgrastim. The similar BPR safety profile of lipegfilgrastim and pegfilgrastim provides support for use in patients with breast cancer receiving chemotherapy.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/tratamiento farmacológico , Dolor Musculoesquelético/inducido químicamente , Adulto , Anciano , Artralgia/inducido químicamente , Dolor de Espalda/inducido químicamente , Neoplasias de la Mama Masculina/tratamiento farmacológico , Neutropenia Febril Inducida por Quimioterapia/etiología , Docetaxel , Método Doble Ciego , Doxorrubicina/administración & dosificación , Femenino , Filgrastim , Factor Estimulante de Colonias de Granulocitos/administración & dosificación , Factor Estimulante de Colonias de Granulocitos/efectos adversos , Humanos , Inyecciones Subcutáneas , Masculino , Persona de Mediana Edad , Mialgia/inducido químicamente , Polietilenglicoles , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversos , Taxoides/administración & dosificaciónRESUMEN
PURPOSE: To predict biochemical recurrence respecting the natural course of pT2 prostate cancer with positive surgical margin (R1) and no adjuvant/neoadjuvant therapy. METHODS: A multicenter data analysis of 956 patients with pT2R1N0/Nx tumors was performed. Patients underwent radical prostatectomy between 1994 and 2009. No patients received neoadjuvant or adjuvant therapy. All prostate specimens were re-evaluated according to a well-defined protocol. The association of pathological and clinical features, in regard to BCR, was calculated using various statistical tests. RESULTS: With a mean follow-up of 48 months, BCR was found in 25.4 %. In univariate analysis, multiple parameters such as tumor volume, PSA, Gleason at positive margin were significantly associated with BCR. However, in multivariate analysis, Gleason score (GS) of the prostatectomy specimen was the only significant parameter for BCR. Median time to recurrence for GS ≤ 6 was not reached; 5-year BCR-free survival was 82 %; and they were 127 months and 72 % for GS 3+4, 56 months and 54 % for GS 4 + 3, and 27 months and 32 % for GS 8-10. The retrospective approach is a limitation of our study. CONCLUSIONS: Our study provides data on the BCR in pT2R1-PCa without adjuvant/neoadjuvant therapy and thus a rationale for an individual's risk stratification. The data support patients and physicians in estimating the individual risk and timing of BCR and thus serve to personalize the management in pT2R1-PCa.
Asunto(s)
Calicreínas/sangre , Recurrencia Local de Neoplasia/sangre , Recurrencia Local de Neoplasia/diagnóstico , Antígeno Prostático Específico/sangre , Prostatectomía , Neoplasias de la Próstata/sangre , Neoplasias de la Próstata/cirugía , Adulto , Anciano , Humanos , Masculino , Persona de Mediana Edad , Clasificación del Tumor , Estadificación de Neoplasias , Neoplasia Residual , Neoplasias de la Próstata/patología , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE: Early recovery after surgery concepts have gained wide acceptance in various surgical specialties. However, limited data are available for radical cystectomy. A new early recovery after surgery concept was compared to a more conservative regimen in patients undergoing radical cystectomy for bladder cancer. MATERIALS AND METHODS: A total of 101 consecutive patients were prospectively randomized to early recovery after surgery (62) or a conservative regimen (39) (intended randomization ratio was 2 early recovery after surgery-to-1 conservative regimen). Primary end points were differences in quality of life, and secondary end points included postoperative morbidity, demand for analgesics, time spent in the intermediate care unit, mobility and number of gastrointestinal events during hospital stay. RESULTS: Quality of life parameters, as measured by the EORTC (European Organization for the Research and Treatment of Cancer) Quality of Life questionnaire QLQ-30 did not change significantly between postoperative days 3 and 7 and at discharge from hospital in the conservative regimen group, whereas a significant improvement was observed in the early recovery after surgery group. Postoperative morbidity was lower in the early recovery after surgery group in terms of wound healing disorders (p = 0.006), fever (p = 0.004) and thrombosis (p = 0.027). The demand for analgesics was significantly lower in the early recovery after surgery group. The amount of food consumed in relation to the amount of food offered was significantly higher for the early recovery after surgery group as early as day 3 (p = 0.02). Time spent in the intermediate care unit was significantly shorter for the early recovery after surgery group (p <0.001). There were no significant differences between the groups with respect to gastrointestinal events. The main limitations of this study were the lack of long-term data as well as the single center approach. CONCLUSIONS: Early recovery after surgery of patients who underwent radical cystectomy appears to have significant benefits compared to a conservative regimen in terms of postoperative morbidity, quality of life, use of analgesics and time spent in the intermediate care unit.
Asunto(s)
Cistectomía , Cuidados Posoperatorios/métodos , Neoplasias de la Vejiga Urinaria/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Cistectomía/métodos , Femenino , Unidades Hospitalarias , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Dolor Postoperatorio/prevención & control , Estudios Prospectivos , Calidad de Vida , Factores de TiempoRESUMEN
BACKGROUND: In clinical practice, the standardized Freiburg speech test is presented via headphones as well as via loudspeakers. To achieve comparable results with both presentation modes, the headphone measurements are equated to the free-field situation. The free-field correction is determined by subjective loudness balance measurements and realized by a free-field equalizer network and a broadband frequency correction value during headphone calibration. Using the Freiburg speech test, this study tested the comparability of free-field and HDA200 headphone measurements. PATIENTS AND METHODS: In 15 normal hearing subjects, the Freiburg speech intelligibility test was performed using both loudspeakers and HDA200 headphones. RESULTS: The 50% speech reception threshold measured using HDA200 headphones was on average 5.1 dB lower than for loudspeakers and lay below the standardized reference values. CONCLUSION: The desired comparability to free-field measurements could not be shown for the HDA200 headphones. The improved intelligibility via HDA200 is probably caused by the fact that the calibration correction factor of 4 dB is too high. This should be checked by the PTB.
Asunto(s)
Estimulación Acústica/instrumentación , Acústica/instrumentación , Audiometría del Habla/instrumentación , Transductores , Estimulación Acústica/métodos , Adulto , Audiometría del Habla/métodos , Diseño de Equipo , Análisis de Falla de Equipo , Femenino , Humanos , Masculino , Valores de Referencia , Adulto JovenRESUMEN
BACKGROUND AND STUDY AIMS: Probe-based confocal laser endomicroscopy (pCLE) is a new imaging modality that enables histological examination of gastrointestinal mucosa during endoscopic procedures. Most studies have evaluated offline interpretation of pCLE images. In clinical practice, real-time interpretation is necessary to assist decision-making during the procedure. The aim of this pilot study was to compare the accuracy of real-time pCLE diagnosis made during the procedure with that of blinded offline interpretation to provide accuracy estimates that will aid the planning of future studies. PATIENTS AND METHODS: pCLE was performed in patients undergoing screening and surveillance colonoscopy. Once a polyp had been identified, one endoscopist analyzed pCLE images during the procedure and made a provisional "real-time" diagnosis. Saved video recordings were de-identified, randomized, and reviewed "offline" 1 month later by the same endoscopist, who was blinded to the original diagnoses. RESULTS: Images from a total of 154 polyps were recorded (80 neoplastic, 74 non-neoplastic). The overall accuracy of real-time pCLE diagnosis (accuracy 79%, sensitivity 81%, specificity 76%) and offline pCLE diagnosis (83%, 88%, and 77%, respectively) for all 154 polyps were similar. Among polyps < 10 mm in size, the accuracy of real-time interpretation was significantly lower (accuracy 78%, sensitivity 71%, specificity 83%) than that of offline pCLE interpretation (81%, 86%, 78%, respectively). For polyps ≥ 10 mm, the accuracy of pCLE diagnosis in real-time was better (accuracy 85%, sensitivity 90%, specificity 75%) than offline pCLE diagnosis (81%, 97%, and 50%, respectively). CONCLUSIONS: These results suggest that real-time and offline interpretations of pCLE images are moderately accurate. Real-time interpretation is slightly less accurate than offline diagnosis, but overall both are comparable. Additionally, there was contrasting accuracy between the two methods for small and large polyps.
Asunto(s)
Adenocarcinoma/patología , Adenoma Velloso/patología , Pólipos del Colon/patología , Neoplasias Colorrectales/patología , Mucosa Intestinal/patología , Microscopía Confocal/métodos , Adulto , Anciano , Anciano de 80 o más Años , Colonoscopía , Femenino , Humanos , Hiperplasia/patología , Masculino , Persona de Mediana Edad , Proyectos Piloto , Sensibilidad y EspecificidadRESUMEN
Objective.One promising approach towards further improving cochlear implants (CI) is to use brain signals controlling the device in order to close the auditory loop. Initial electroencephalography (EEG) studies have already shown promising results. However, they are based on noninvasive measurements, whereas implanted electrodes are expected to be more convenient in terms of everyday-life usability. If additional measurement electrodes were implanted during CI surgery, then invasive recordings should be possible. Furthermore, implantation will provide better signal quality, higher robustness to artefacts, and thus enhanced classification accuracy.Approach.In an initial project, three additional epidural electrodes were temporarily implanted during the surgical procedure. After surgery, different auditory evoked potentials (AEPs) were recorded both invasively (epidural) and using surface electrodes, with invasively recorded signals demonstrated as being markedly superior. In this present analysis, cortical evoked response audiometry (CERA) signals recorded in seven patients were used for single-trial classification of sounds with different intensities. For classification purposes, we used shrinkage-regularized linear discriminant analysis (sLDA). Clinical speech perception scores were also investigated.Main results.Analysis of CERA data from different subjects showed single-trial classification accuracies of up to 99.2% for perceived vs. non-perceived sounds. Accuracies of up to 89.1% were achieved in classification of sounds perceived at different intensities. Highest classification accuracies were achieved by means of epidural recordings. Required loudness differences seemed to correspond to speech perception in noise.Significance.The proposed epidural recording approach showed good classification accuracy into sound perceived and not perceived when the best-performing electrodes were selected. Classifying different levels of sound stimulation accurately proved more challenging. At present, the methods explored in this study would not be sufficiently reliable to allow automated closed-loop control of CI parameters. However, our findings are an important initial contribution towards improving applicability of closed auditory loops and for next-generation automatic fitting approaches.
Asunto(s)
Implantación Coclear , Implantes Cocleares , Percepción del Habla , Implantación Coclear/métodos , Electroencefalografía/métodos , Potenciales Evocados Auditivos/fisiología , Humanos , Percepción del Habla/fisiologíaRESUMEN
AIMS: Image-defined risk factors (IDRFs) in neuroblastoma predict surgical complications and management outcomes. As there is a lack of data regarding the association of IDRFs with clinical and pathological factors, this study evaluated the prognostic value of IDRFs to predict neuroblastoma survival outcomes. MATERIALS AND METHODS: This was a retrospective study including 345 patients and reviewed diagnostic imaging for 20 IDRFs, pleural effusions and ascites. The IDRFs were grouped into five 'primary IDRFs' cohorts with vascular encasement, involvement of multiple body compartments, organ infiltration, airway obstruction and intraspinal extension. The association between clinical, histopathological and biological characteristics of neuroblastoma and management was evaluated. RESULTS: More patients without IDRFs had operations compared with patients with IDRFs, with a trend towards significance (64.4% versus 35.6%, P = 0.082). Patients with multiple compartment tumour involvement (P = 0.003) and organ infiltration (P < 0.001) had a higher risk of surgical complications. The 5-year overall survival of the group with more than one IDRF was 0.0% and those with pleural effusions or ascites 6.7%, associated with the worst outcome (P = 0.005). The total number of IDRFs was not predictive of the metastatic remission rate (P = 0.585) or overall survival (P = 0.142), with no conclusive association found between IDRF groups and clinical or biological markers. CONCLUSIONS: Patients with more than one IDRF had the shortest survival time, whereas those with pleural effusions and ascites at diagnosis had a poor outcome. Standardised reporting of IDRFs is crucial for predicting prognosis.
Asunto(s)
Neuroblastoma , Derrame Pleural , Ascitis/etiología , Ascitis/patología , Biomarcadores de Tumor , Humanos , Estadificación de Neoplasias , Neuroblastoma/diagnóstico por imagen , Neuroblastoma/cirugía , Derrame Pleural/patología , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , Sudáfrica/epidemiología , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND AND AIMS: Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) enables in vivo histology during colonoscopy and may allow endoscopists to make real-time diagnoses. A collaboration of five experts proposed a new pCLE classification for colonic use. The aim of this study was to assess interobserver agreement and accuracy of the new pCLE classification in the colon. PATIENTS AND METHODS: Eligible patients were prospectively investigated by pCLE. A subset of 13âpCLE video sequences was reviewed post hoc for the establishment of a new classification, which comprised three vessel categories and seven crypt categories. All five blinded observers then scored another set of 102 video sequences, using the new classification. Histopathology was used as a reference standard. RESULTS: The interobserver agreements on vessel and crypt architecture were 'fair' with kappa values of 0.29 and 0.27, respectively. When the classification was reduced to neoplasia vs. non-neoplasia (i.e. vessel or crypt type 3), overall agreement became 'moderate' (κ = 0.56). Overall sensitivity and specificity for predicting neoplasia was 66 % and 83 %, respectively. When all observers agreed (69 % of videos), the corresponding figures became 80 % and 95 %. CONCLUSION: A new classification for pCLE in the colon had a 'moderate' interobserver agreement for differentiating neoplasia from non-neoplastic tissue in the colon. The overall accuracy (81 %) for predicting neoplasia was acceptable and became excellent (94 %) when all five observers agreed. Future research should focus on refinement and validation of the classification.
Asunto(s)
Neoplasias del Colon/clasificación , Colonoscopía , Microscopía Confocal , Adulto , Anciano , Neoplasias del Colon/diagnóstico , Neoplasias del Colon/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Sensibilidad y Especificidad , Grabación en VideoRESUMEN
BACKGROUND AND STUDY AIMS: Colonoscopy is widely used to detect and remove precancerous polyps, but fails to detect some polyps. Recent studies evaluating different image-enhanced methods have revealed conflicting results. The efficacy of colonoscopy imaging with simultaneous use of commercially available improvements, including high definition narrow band imaging (HD-NBI), and monochromatic charge-coupled device (CCD) video, was compared with a widely used standard definition white light (SDWL) colonoscopy system for detecting colorectal polyps. The primary aim was to determine whether the combination of image-enhanced colonoscopy systems resulted in fewer missed polyps compared with conventional colonoscopy. PATIENTS AND METHODS: In a randomized controlled trial (Clinicaltrials.gov. study number NCT00825292) patients having routine screening and surveillance underwent tandem colonoscopies with SDWL and image-enhanced (HD-NBI) colonoscopy. The main outcome measurement was the per-polyp false-negative ("miss") rate. Secondary outcomes were adenoma miss rate, and per-patient polyp and adenoma miss rates. RESULTS: 100 patients were randomized and 96 were included in the analysis. In total, 177 polyps were detected; of these, 72 (41 %) were adenomatous. Polyp and adenoma miss rates for SDWL colonoscopy were 57 % (60/105) and 49 % (19/39); those for image-enhanced colonoscopy were 31 % (22/72) and 27 % (9/33) (P = 0.005 and P = 0.036 for polyps and adenomas, respectively). Image-enhanced and SDWL approaches had similar per-patient miss rates for polyps (6/35 vs. 9/32, P = 0.27) and adenomas (4/22 vs. 8/20, P = 0.11). CONCLUSIONS: Utilization of multiple recent improvements in image-enhanced colonoscopy was associated with a reduced miss rate for all polyps and for adenomatous polyps. It is not known which individual feature or combination of image-enhancement features led to the improvement.
Asunto(s)
Pólipos del Colon/diagnóstico , Colonoscopía/métodos , Aumento de la Imagen , Anciano , Femenino , Humanos , Procesamiento de Imagen Asistido por Computador , Masculino , Persona de Mediana Edad , Lesiones Precancerosas/diagnósticoRESUMEN
INTRODUCTION: Pelvic lymphoceles (LC) following radical prostatectomy (LC-RP) have an incidence up to 27%. LC-managements constitute 50% of surgical interventions performed in post-RP patients. OBJECTIVES: To describe a therapeutic algorithm for LC-managements based on a community based representative retrospective study. PATIENTS AND METHODS: Multicentre data from 304 patients with LC-RP were retrospectively examined for LC-managements. RPs were performed by various surgeons from 67 urological departments. All patients had undergone 3 weeks rehabilitation in a specialized hospital where the data base was generated. Indications and results of therapeutic manoeuvres were used to develop a general concept for planning therapy decisions. - RESULTS: Median age was 64 years. Complications occurred in 9% (28/304) of patients. Median LC-volume was 36ml (range 20-1800ml). There were more complications for LCs with ≥ 100ml volume than those <100ml (27% versus 17%, p = 0.346). Conservative therapy was the standard in uncomplicated cases (87%, 239 of 276 patients), while intervention was done in 13% (puncture and/or drainage, surgery). Surgical intervention was performed significantly more often in complicated cases (82%, 23 from 28 patients; p<0.001). Based on these data, LCs can be stratified into 3 groups depending on the size and clinical presentation. Therapeutic decisions were used to develop the illustrated new therapy algorithm. CONCLUSIONS: This study based treatment algorithm provides a rationale approach with an accurate LC-classification as regard the indications and decision making for the available LC-RP-therapies. This could facilitate management decisions. Evaluation of this concept prospectively in large patient cohort is mandatory.
Asunto(s)
Linfocele/etiología , Linfocele/terapia , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/terapia , Prostatectomía/efectos adversos , Anciano , Algoritmos , Toma de Decisiones Asistida por Computador , Humanos , Linfocele/patología , Masculino , Persona de Mediana Edad , Pelvis , Complicaciones Posoperatorias/patología , Estudios RetrospectivosRESUMEN
INTRODUCTION: In a previous study we evaluated the risk for malnutrition among urological patients in a German university hospital. There are published different studies in other surgical fields that could show a correlation between malnutrition and clinical outcome. As data on this issue is still rare in the urological field we aimed to correlate the risk of malnutrition with different parameters regarding clinical outcome. METHODS: In the time from 2007 to 2009 a total of 320 patients were evaluated regarding the risk of malnutrition and occurrence of complications during the time of hospitalization at our Urological department. The Nutritional risk screening 2002 (NRS) by Kondrup et al. was used for the estimation of the risk level for malnutrition. Patients of a German university hospital were included independently of intervention, age or gender. Parameters for clinical outcome were: pulmonary complications (infectious/noninfectious), cardiovascular complications (infectious/noninfectious), other infections (urinary tract infection etc.), wound healing disorders and time of hospitalization. RESULTS: In this evaluation 320 patients were included for analysis. Forty patients (13%) presented with a normal nutritional status (NRS score 0) at the time of admission to the hospital and 212 patients (66%) were at risk for forming malnutrition problems (NRS score 1-2). Sixty eight patients (21%) of this urological cohort were detected with a malnutrition according to the applied NRS Score (≥3). Regarding the occurrence of overall complications in this cohort the rate was rather low compared to other surgical fields. Of 320 patients only 22 patients (7%) presented with relevant complications during their hospitalization. However if data were stratified for peri- and postoperative complications in correlation to nutritional status of patients, an evident trend to a higher complication rate of 9% was obvious. CONCLUSIONS: In our cohort of exclusively urological patients, the risk for post-surgical complications was higher in patients who were malnourished as defined using the Nutritional Risc Screening System (NRS) by Kondrup et al. Further studies need to show whether an adequate nutritional supportive therapy could help to optimize the clinical outcome of malnourished urological patients.
Asunto(s)
Desnutrición/etiología , Enfermedades Urológicas/complicaciones , Anciano , Femenino , Hospitalización , Humanos , Masculino , Desnutrición/prevención & control , Evaluación Nutricional , Apoyo Nutricional , Estudios Prospectivos , Factores de Riesgo , Tasa de Supervivencia , Resultado del Tratamiento , Enfermedades Urológicas/terapiaAsunto(s)
Implantación Coclear , Cefalea , Percepción del Habla , Implantes Cocleares , Sordera , Pérdida Auditiva Bilateral , Humanos , HablaRESUMEN
OBJECTIVE: To evaluate if MRI/ultrasound fusion based targeted biopsy (FBx) leads to a reduced rate of change in Gleason score (GS) compared to prostatectomy specimen. METHODS: The histopathological findings of the biopsy of the prostate and the radical prostatectomy (RP) specimen of 210 patients who were referred to our hospital between 2012 and 2017 were compared retrospectively in this study. One hundred and five patients who underwent FBx combined with ultrasound-guided 12-core biopsy of the prostate (SBx) were matched with 105 patients who underwent SBx only. This study evaluated the rate of up- or downgrading in the RP specimen in both groups and compared the results via matched pair analysis. RESULTS: Concordance in Gleason grade group (GGG) was found in 52/105 patients (49.5%) in SBx and in 49/105 patients (46.7%) with FBx (p = 0.679). The rate of downgrading was statistically significant (p = 0.014) and was higher in the FBx group (14/105 patients, 13.3%) than in the SBx group (4/105 patients, 3.8%). A higher rate of upgrading was seen in SBx (49/105 patients; 46.7%) compared to FBx (42/105 patients; 40%), with no statistical significance (p = 0.331). The change in GGG from biopsy to final pathology in patients with GGG 1 and 2 at biopsy level was not statistically significant (p = 0.168). CONCLUSION: FBx does not decrease the rate of upgrading between biopsy and final pathology in RP specimens. Our results indicate that FBx tends to overestimate the final GGG compared to SBx.
Asunto(s)
Neoplasias de la Próstata/patología , Neoplasias de la Próstata/cirugía , Anciano , Biopsia con Aguja Gruesa , Humanos , Biopsia Guiada por Imagen , Imagen por Resonancia Magnética , Masculino , Análisis por Apareamiento , Persona de Mediana Edad , Clasificación del Tumor , Periodo Posoperatorio , Estudios Retrospectivos , Ultrasonografía IntervencionalRESUMEN
INTRODUCTION: The aim of residency is to acquire medical skills and abilities. One didactic model is "Peyton's four-step approach". The aim of the present study was to develop and evaluate a modified Peytonian approach for group interactions. The aim was to develop a course for the acquisition of practical skills and training assistants in suture techniques for urology. METHODS: A prospective study was conducted with a total of 38 participants and 6 tutors. In a modified four-step Peytonian approach, various suturing and knotting techniques were taught in a structured manner. Tutors evaluated the procedural activity using observation sheets. In addition, the learning method was evaluated by the participants and the tutors at the end of the course. In order to check the long-term learning success, a renewed survey of the participants was conducted after 6 months. RESULTS: 80% of the participants rated the modified teaching method as useful and 83% of the tutors rated the procedural implementation as good. Fluid movement sequences were difficult independent of the technique taught. After 6 months, the participants significantly improved their procedural skills in all techniques that were taught. CONCLUSION: This paper defines a four-step Peyton-based approach to teaching practical skills such as suturing and knotting used in urological training. The modified teaching method improved practical skills used in urology. This method should be considered in continuing education to promote self-confidence and increase the competence in surgical skills.
Asunto(s)
Educación de Pregrado en Medicina , Internado y Residencia , Urología , Competencia Clínica , Curriculum , Humanos , Estudios ProspectivosRESUMEN
BACKGROUND AND STUDY AIMS: A recently developed probe-based, confocal laser endomicroscopy (pCLE) system provides images of surface colonic epithelium in vivo during any endoscopy. Our objective was to assess interobserver agreement, sensitivity, specificity, and overall accuracy in the diagnosis of neoplasia using pCLE. PATIENTS AND METHODS: 53 patients undergoing surveillance and screening colonoscopies were enrolled. A total of 75 lesions, were detected and all were inspected by pCLE prior to sampling or polypectomy. Intravenous fluorescein was used to optimize tissue contrast. Three pCLE users, blinded to histopathologic and endoscopic findings, reviewed the set of video sequences for crypt architecture, vessel architecture, and colorectal neoplasia diagnosis. Histopathologic diagnosis from the corresponding biopsies was the reference gold standard. RESULTS: Of the 75 colorectal lesions, 50 were neoplastic and 25 non-neoplastic. Interobserver agreement was moderate to good for the classification of neoplasia (kappa 0.55, 78 % pairwise agreement), and moderate for vessel architecture (kappa 0.41, 67 % pairwise agreement) and crypt architecture (kappa 0.49, 69 % pairwise agreement). In distinguishing between neoplastic and non-neoplastic lesions, sensitivity, specificity, and accuracy were 76 %, 72 % and 75 %, respectively. When videos of good or excellent quality only were considered, interobserver agreement for classification of neoplasia was higher (kappa 0.83, 92 % pairwise agreement), as were sensitivity (88 %), specificity (89 %), and accuracy (88 %). CONCLUSION: An international collaboration group had moderate to good interobserver agreement using a pCLE system to predict neoplasia, which is acceptable for this study.