Urologic oncology
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Multicenter Study
The effect of surgical duration of transurethral resection of bladder tumors on postoperative complications: An analysis of ACS NSQIP data.
Transurethral resection of bladder tumor (TURBT) is a common procedure used in the diagnosis and treatment of bladder cancer. Despite how often it is performed, not much is known about the risk factors for complications. Traditional surgery has an increase in morbidity and mortality with increasing operative duration. We assess the effect of operative duration on TURBT complications. ⋯ Using a contemporary multicenter cohort of TURBTs from the ACS NSQIP database, we demonstrate that increased operative duration is associated with serious postoperative complications. This association was found to persist even after adjusting for patient age, comorbidities, tumor size, and functional status.
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To investigate diagnostic performance of diffusion kurtosis imaging with histogram analysis for stratifying pathologic Gleason grade of prostate cancer (PCa). ⋯ It demonstrated a good reliability of histogram diffusion kurtosis imaging for stratifying pathologic GS of PCa. The 90th K(app) had better diagnostic performance in differentiating LG-PCa from HG-PCa.
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To evaluate the prognostic effect of concomitant variant histology (CVH) on survival outcomes in patients with upper urinary tract urothelial carcinoma (UTUC) after radical nephroureterectomy. ⋯ Approximately one-fifth of the specimens of patients with UTUC were observed to exhibit CVH. CVH was an independent prognostic factor for CSS, DFS, and OS in patients with UTUC on both univariate and multivariate analyses. Genitourinary pathologists should look for potential CVH components in UTUC specimens and report this in routine pathological practice. The presence of CVH should identify patients as candidates for consultation regarding early adjuvant therapy and intensive surveillance protocols.
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Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. The FDA was granted the authority to regulate the manufacturing and marketing of medical devices in 1976. ⋯ Premarket approval applications must contain data demonstrating reasonable assurance of safety and efficacy, and this information typically includes clinical data. For novel devices that are not high risk, the de novo process allows FDA to simultaneously review and classify new devices. Devices that are not legally marketed are permitted to be used for clinical investigation purposes in the United States under the Investigational Device Exemptions regulation.