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1.
Farrukh Aslam Khalid Usman Khalid Farooq Muhammad Saleem Jibran Rabbani Muhammad Amin Kamal Uddin Khan Younas Mehrose Moazzam N. Tarar 《Burns : journal of the International Society for Burn Injuries》2018,44(6):1489-1495
Background
The ear is the common site for keloid formation especially in women after ear piercing. Surgery is the main stay of treatment in these lesions but there are large numbers of treatment failures in surgery alone.Objective
The objective of this study was to compare the efficacy of post-excision intralesional 5-fluorouracil/triamcinolone acetonide (5-FU/TAC) and post-excision radiotherapy in the treatment of ear keloids.Study design
A randomized controlled trial.Setting
The study was conducted from May 2014 to January 2015 at Jinnah Burn and Reconstructive Surgery Centre, Allama Iqbal Medical College, Lahore.Subject & methodology
After approval from the hospital ethical committee, 60 patients presented in the outpatient department fulfilling the inclusion criteria were selected and randomly assigned in two groups with the help of the random number table. Patients in group A had excision followed by intralesional 5-FU/TAC injections while patients of group B had excision followed by radiotherapy.Patients were assessed at 6 months after completion of treatment for efficacy (no recurrence within 6 months of treatment).Results
In our study total of 60 patients completed the study, with 30 patients in each group. 7 patients (23.34%) in Group-A and 9 patients (30%) in Group-B were males while 23 patients (76.67%) in Group-A and 21 patients (70%) in Group-B were females i.e. male to female ratio is 1:2.75. Mean age was 31.8 + 6.48 years. The comparison of frequency of efficacy in both groups showed that 73.33% (n = 22) in Group-A and 43.33% (n = 13) in Group-B had efficacy, p value was calculated as 0.01, showing a significant statistical difference.Conclusion
Excision and intralesional 5-FU/TAC is an effective treatment for keloids on the ears. 相似文献2.
Jodie Wiseman Megan Simons Roy Kimble Zephanie Tyack 《Burns : journal of the International Society for Burn Injuries》2019,45(1):103-113
Background
Current consensus for the ideal pressure range at the pressure garment to scar interface is 15–25 mmHg. Interface pressure variability has been reported at new pressure garment fitting in children. Pressure reductions up to 25% have been recorded over one month in adults.Method
A pilot longitudinal cohort study was completed with children aged less than 18 years receiving pressure garment therapy after burn. Interface pressure was measured at first pressure garment fitting, one month and three months after fitting. Analysis was conducted using Linear Mixed Models.Results
Thirty-four children were recruited to the study, 62% were male. Participants had a median (IQR) age of 3 (6) years. At the first garment fitting, 32% of stationary and 25% of dynamic measurements were within 15–25 mmHg. Pressure variations were recorded at one and three months with scar location (p = 0.03) and %TBSA (p = 0.006) identified as predictors of stationary interface pressure. No statistically significant predictors of dynamic pressure were identified.Discussion
Interface pressure variability was recorded over time during children’s wear of the first pressure garment after burn. Further investigation of factors contributing to pressure changes, subsequent impact on adherence and the effect of sub-optimal pressure application on burn scar outcomes is indicated. 相似文献3.
Vincenzo Ficarra Gianluca Giannarini Alessandro Crestani Vito Palumbo Marta Rossanese Claudio Valotto Antonino Inferrera Vito Pansadoro 《European urology》2019,75(2):294-299
Background
Ureteroileal anastomotic stricture (UAS) after ileal conduit diversion occurs in a non-negligible proportion of patients undergoing radical cystectomy (RC). Surgical techniques aimed at preventing this potential complication are sought.Objective
To describe our surgical technique of retrosigmoid ileal conduit, and to assess perioperative outcomes and postoperative complications with a focus on UAS rate.Design, setting, and participants
A prospective single-centre, single-surgeon cohort of 67 consecutive patients undergoing open RC with ileal conduit urinary diversion between July 2013 and April 2017 was analysed. A study group of 30 patients receiving retrosigmoid ileal conduit was compared with a control group of 37 patients receiving standard Wallace ileal conduit.Surgical procedure
Retrosigmoid versus Wallace ileal conduit diversion after open RC.Measurements
Operative room (OR) time, estimated blood loss (EBL), transfusion rate, and 90-d postoperative complications were recorded and compared between the two groups. In particular, rate of UAS, defined as upper collecting system dilatation requiring endourological or surgical management, was assessed and compared.Results and limitations
The two groups were comparable with regard to all demographic, clinical, and pathological variables. No differences were observed in terms of OR time (p = 0.35), EBL (p = 0.12), and transfusion rate (p = 0.81). Ninety-day postoperative complications were observed in 11 (36.7%) patients who underwent a retrosigmoid ileal conduit and 20 (54.1%) patients who received a traditional ileal conduit (p = 0.32). Major complications (grade 3–4) were observed in three (10%) cases in the former group and in 12 (32.4%) cases in the latter group (p = 0.08). Mean (standard deviation) follow-up time was 10.8 ± 4.0 mo in the study group and 27.5 ± 9.5 mo in the control group (p < 0.001). No single case of UAS was observed in the study group, whereas six (16.2%) cases of UAS occurred in the control group (p = 0.02). The main limitation is a nonrandomised comparison of a relatively small cohort with short-term follow-up.Conclusions
In our study, we observed a significantly reduced rate of UAS and no increase in postoperative complications with the retrosigmoid ileal conduit diversion compared with standard Wallace ileal conduit diversion after open RC.Patient summary
We describe our surgical technique of retrosigmoid ileal conduit as urinary diversion after open radical cystectomy. Compared with traditional techniques, our technique for ileal conduit was found to be safe and reduce the risk of ureteric strictures. 相似文献4.
Jacob A. Burns Adam B. Weiner William J. Catalona Eric V. Li Edward M. Schaeffer Stephen B. Hanauer Scott Strong James Burns Maha H.A. Hussain Shilajit D. Kundu 《European urology》2019,75(5):846-852
Background
There are limited data examining the risk of prostate cancer (PCa) in patients with inflammatory bowel disease (IBD).Objective
To compare the incidence of PCa between men with and those without IBD.Design, setting, and participants
This was a retrospective, matched-cohort study involving a single academic medical center and conducted from 1996 to 2017. Male patients with IBD (cases = 1033) were randomly matched 1:9 by age and race to men without IBD (controls = 9306). All patients had undergone at least one prostate-specific antigen (PSA) screening test.Outcome measurements and statistical analysis
Kaplan-Meier and multivariable Cox proportional hazard models, stratified by age and race, evaluated the relationship between IBD and the incidence of any PCa and clinically significant PCa (Gleason grade group ≥2). A mixed-effect regression model assessed the association of IBD with PSA level.Results and limitations
PCa incidence at 10 yr was 4.4% among men with IBD and 0.65% among controls (hazard ratio [HR] 4.84 [3.34–7.02] [3.19–6.69], p < 0.001). Clinically significant PCa incidence at 10 yr was 2.4% for men with IBD and 0.42% for controls (HR 4.04 [2.52–6.48], p < 0.001). After approximately age 60, PSA values were higher among patients with IBD (fixed-effect interaction of age and patient group: p = 0.004). Results are limited by the retrospective nature of the analysis and lack of external validity.Conclusions
Men with IBD had higher rates of clinically significant PCa when compared with age- and race-matched controls.Patient summary
This study of over 10 000 men treated at a large medical center suggests that men with inflammatory bowel disease may be at a higher risk of prostate cancer than the general population. 相似文献5.
Background
A recent case series suggested that surgery with wide-awake local anesthesia is tolerated well by most foot and ankle patients. However, patients were assessed retrospectively and there was no comparison group to show the relative efficacy of this approach. The present study was conducted to address these concerns.Methods
Perioperative pain and anxiety were assessed in 40 patients receiving forefoot surgery using either wide-awake local anesthesia or general anesthesia. Ratings were collected on the day of surgery using 11-point (0–10) numerical rating scales.Results
Patients in the two anesthesia groups reported no differences in preoperative pain (p = 0.500) or anxiety (p = 0.820). Patients who received wide-awake local anesthesia reported lower levels of postoperative pain (p < 0.001) and anxiety (p < 0.001) than patients who received general anesthesia. They also reported little pain (M = 0.17, SD = 0.32) or anxiety (M = 1.33, SD = 1.74) during the operation.Conclusions
Results indicate that surgery with wide-awake local anesthesia is tolerated well by most patients, and that it may have some benefit compared to surgery with general anesthesia. 相似文献6.
A. Gasparetto M. Rosenberg D. Hunter J. Golzarian D. D&#x;Souza 《Diagnostic and interventional imaging》2019,100(1):25-29
Purpose
The purpose of this study was to compare the trans-abdominal (TA) and trans-oral (TO) approaches for fluoroscopic-guided gastrostomy tube placement in patients with chronic ascites.Materials and methods
A 10-year review of clinical imaging and medical records at a single institution identified 29 patients with chronic recurrent ascites who underwent gastrostomy (GT) or gastro-jejunostomy tube (GJT) placement. In 22 patients (18 women, 4 men) aged from 22 to 76 years of age (mean age, 57.7 ± 13.1 years), a GT or GJT was placed with the TO approach, and in 7 (7 women) from 31 to 86 years of age (mean age, 63 ± 16.8 years) with the TA approach.Results
Technical success was 100% in both groups with one (1/22; 5%) immediate complication in the TO group. Fluoroscopy time was significantly greater in the TO group (P = 0.002). Leakage of ascites was significantly more frequent in the TA group (P = 0.04). There was no significant difference in bleeding or inflammation (P = 0.14 and P = 0.43, respectively). The cumulative tract related complication rate was significantly greater in the TA group (P = 0.03).Conclusion
Fluoroscopy times and the overall incidence of tract-related complications, in particular leakage of ascites from the stoma, are more frequent in patients in chronic ascites who underwent TA gastrostomy tube placement compared to those who underwent TO placement. 相似文献7.
Paolo Capogrosso Emily A. Vertosick Nicole E. Benfante James A. Eastham Peter J. Scardino Andrew J. Vickers John P. Mulhall 《European urology》2019,75(2):221-228
Background
The last decade has seen several advances in radical prostatectomy (RP) technique and post-RP care that are relevant to erectile function (EF) recovery.Objective
We examined whether these practice changes have led to observed improvements in EF rates over time.Design, setting, and participants
We identified 2364 patients treated with either open or minimally-invasive RP at a single academic center in 2008–2015. To mitigate confounding by the surgical learning curve, only patients treated by surgeons who performed at least 100 procedures were considered.Intervention
EF before and after RP was assessed by the International Index of Erectile Function 6 (IIEF-6), with recovery defined as IIEF-6 ≥24.Outcome measurements and statistical analysis
We analyzed EF recovery rates of patients treated with bilateral nerve-sparing surgery and free from adjuvant/salvage treatment at the time of EF assessment. Local polynomial regression analyses explored changes in the outcomes over time. Linear and logistic regression analyses were used to estimate the influence of year of surgery on baseline variables and EF recovery.Results and limitations
We observed a significant decrease over time of the EF recovery rates at both 12 and 24 mo post-RP (all p = 0.01). However, patient's age at surgery increased over time (mean increase of 0.5 per year; p < 0.01), with a resultant increase in risk of comorbidity (odds ratio [OR] = 1.1, 95% confidence interval [CI]: 1.02–1.15; p = 0.008) and thus decrease in baseline IIEF-6 score (0.35 points per year; p = 0.0003). After accounting for baseline and pathological characteristics, urinary function, and type of surgery in a multivariable analysis, year of surgery was not associated with EF recovery (12 mo: OR = 0.97, 95% CI: 0.91–1.03, p = 0.4; 24 mo: OR = 0.97, 95% CI: 0.91–1.03, p = 0.3).Conclusions
Findings from a high-volume center suggest that, despite the advancements in surgical and postoperative care, EF outcomes after RP have not improved over the last decade. Additional strategies are required to improve EF recovery after RP.Patient summary
The probability of regaining potency after surgery for prostate cancer did not improve over the last decade; more efforts are needed to improve patient's care after radical prostatectomy. 相似文献8.
H. Ballentine Carter Brian Helfand Mufaddal Mamawala Yishuo Wu Patricia Landis Hongjie Yu Kathleen Wiley Rong Na Zhuqing Shi Jacqueline Petkewicz Sameep Shah Richard J. Fantus Kristian Novakovic Charles B. Brendler S. Lilly Zheng William B. Isaacs Jianfeng Xu 《European urology》2019,75(5):743-749
Background
Mutations in DNA repair genes are associated with aggressive prostate cancer (PCa).Objective
To assess whether germline mutations are associated with grade reclassification (GR) in patients undergoing active surveillance (AS).Design, setting, and participants
Two independent cohorts of PCa patients undergoing AS; 882 and 329 patients from Johns Hopkins and North Shore, respectively.Outcome measurements and statistical analysis
Germline DNA was sequenced for DNA repair genes, including BRCA1/2 and ATM (three-gene panel). Pathogenicity of mutations was defined according to the American College of Medical Genetics guidelines. Association of mutation carrier status and GR was evaluated by a competing risk analysis.Results and limitations
Of 1211, 289 patients experienced GR; 11 of 26 with mutations in a three-gene panel and 278 of 1185 noncarriers; adjusted hazard ratio (HR) = 1.96 (95% confidence interval [CI] = 1.004–3.84, p = 0.04). Reclassification occurred in six of 11 carriers of BRCA2 mutations and 283 of 1200 noncarriers; adjusted HR = 2.74 (95% CI = 1.26–5.96, p = 0.01). The carrier rates of pathogenic mutations in the three-gene panel, and BRCA2 alone, were significantly higher in those reclassified (3.8% and 2.1%, respectively) than in those not reclassified (1.6% and 0.5%, respectively; p = 0.04 and 0.03, respectively). Carrier rates for BRCA2 were greater for those reclassified from Gleason score (GS) 3 + 3 at diagnosis to GS ≥4 + 3 (4.1% vs 0.7%, p = 0.01) versus GS 3 + 4 (2.1% vs 0.6%; p = 0.03). Results are limited by the small number of mutation carriers and an intermediate end point.Conclusions
Mutation status of BRCA1/2 and ATM is associated with GR among men undergoing AS.Patient summary
Men on active surveillance with inherited mutations in BRCA1/2 and ATM are more likely to harbor aggressive prostate cancer. 相似文献9.
Daniel J. Canter Julia Reid Maria Latsis Margaret Variano Shams Halat Saradha Rajamani Kristen E. Gurtner Zaina Sangale Michael Brawer Steven Stone Stephen Bardot 《European urology》2019,75(3):515-522
Background
Better prostate cancer risk stratification is necessary to inform medical management, especially for African American (AA) men, for whom outcomes are particularly uncertain.Objective
To evaluate the utility of both a cell cycle progression (CCP) score and a clinical cell-cycle risk (CCR) score to predict clinical outcomes in a large cohort of men with prostate cancer highly enriched in an AA patient population.Design, setting, and participants
Patients were diagnosed with clinically localized adenocarcinoma of the prostate and treated at The Ochsner Clinic (New Orleans, LA, USA) from January 2006 to December 2011. CCP scores were derived from archival formalin-fixed, paraffin-embedded biopsy tissue. CCR scores were calculated as the combination of molecular (CCP score) and clinical (Cancer of the Prostate Risk Assessment [CAPRA] score) components.Intervention
Active treatment (radical prostatectomy, radiation therapy alone, or radiation and hormone therapy) or watchful waiting.Outcome measurements and statistical analysis
The primary outcome was progression to metastatic disease. Association with outcomes was evaluated via Cox proportional hazards survival analysis and likelihood ratio tests.Results and limitations
The final cohort included 767 men, of whom 281 (36.6%) were AA. After accounting for ancestry, treatment, and CAPRA in multivariable analysis, the CCP score remained a significant predictor of metastatic disease (hazard ratio [HR] 2.04; p < 0.001), and there was no interaction with ancestry (p = 0.20) or treatment (p = 0.09). The CCR score was highly prognostic (HR 3.86; p < 0.001), and as with the CCP score, there was no interaction with ancestry (p = 0.24) or treatment (p = 0.32). Limitations include the retrospective study design and the use of self-reported ancestry information.Conclusions
A CCR score provided significant prognostic information regardless of ancestry. The findings demonstrate that AA men in this study cohort appear to have similar prostate cancer outcomes to non-AA patients after accounting for all available molecular and clinicopathologic variables.Patient summary
In this study we evaluated the ability of a combined molecular and clinical score to predict the progression of localized prostate cancer. We found that the combined molecular and clinical score predicted progression to metastasis regardless of patient ancestry or treatment. This suggests that the combined molecular and clinical score may be a valuable tool for determining the risk of metastasis in men with newly diagnosed prostate cancer in order to make appropriate treatment decisions. 相似文献10.
Wei Shen Tan Anesh Panchal Laura Buckley Adam J. Devall Laurence S. Loubière Ann M. Pope Mark R. Feneley Jo Cresswell Rami Issa Hugh Mostafid Sanjeev Madaan Rupesh Bhatt John McGrath Vijay Sangar T.R. Leyshon Griffiths Toby Page Dominic Hodgson Shibendra N. Datta John D. Kelly 《European urology》2019,75(1):63-71
Background
There is no effective intravesical second-line therapy for non–muscle-invasive bladder cancer (NMIBC) when bacillus Calmette-Guérin (BCG) fails.Objective
To compare disease-free survival time (DFS) between radiofrequency-induced thermo-chemotherapy effect (RITE) and institutional standard second-line therapy (control) in NMIBC patients with recurrence following induction/maintenance BCG.Design, settings, and participants
Open-label, phase III randomised controlled trial accrued across 14 centres between May 2010 and July 2013 (HYMN [ClinicalTrials.gov: NCT01094964]).Intervention
Patients were randomly assigned (1:1) to RITE (60 min, 40 mg mitomycin-C, 42 ± 2 °C) or control following stratification for carcinoma in situ (CIS) status (present/absent), therapy history (failure of previous induction/maintenance BCG), and treatment centre.Outcome measurements and statistical analysis
Primary outcome measures were DFS and complete response (CR) at 3 mo for the CIS at randomisation subgroup. Analysis was based on intention-to-treat.Results and limitations
A total of 104 patients were randomised (48 RITE: 56 control). Median follow-up for the 31 patients without a DFS event was 36 mo. There was no significant difference in DFS between treatment arms (hazard ratio [HR] 1.33, 95% confidence interval [CI] 0.84–2.10, p = 0.23) or in 3-mo CR rate in CIS patients (n = 71; RITE: 30% vs control: 47%, p = 0.15). There was no significant difference in DFS between treatment arms in non-CIS patients (n = 33; RITE: 53% vs control: 24% at 24 mo, HR 0.50, 95% CI 0.22–1.17, p = 0.11). DFS was significantly lower in RITE than in control in CIS with/without papillary patients (n = 71; HR 2.06, 95% CI 1.17–3.62, p = 0.01; treatment-subgroup interaction p = 0.007). Disease progression was observed in four patients in each treatment arm. Adverse events and health-related quality of life between treatment arms were comparable.Conclusions
DFS was similar between RITE and control. RITE may be a second-line therapy for non-CIS recurrence following BCG failure; however, confirmatory trials are needed. RITE patients with CIS with/without papillary had lower DFS than control. HYMN highlights the importance of the control arm when evaluating novel therapies.Patient summary
This study did not show a difference in bladder cancer outcomes between microwave-heated chemotherapy and standard of care treatment. Papillary bladder lesions may benefit from microwave-heated chemotherapy treatment; however, more research is needed. Both treatments are similarly well tolerated. 相似文献11.
Liselotte M.S. Boevé Maarten C.C.M. Hulshof André N. Vis Aeilko H. Zwinderman Jos W.R. Twisk Wim P.J. Witjes Karl P.J. Delaere R. Jeroen A. van Moorselaar Paul C.M.S. Verhagen George van Andel 《European urology》2019,75(3):410-418
Background
The cornerstone of standard treatment for patients with primary bone metastatic prostate cancer (mPCa) is androgen deprivation therapy (ADT). Retrospective studies suggest a survival benefit for treatment of the primary prostatic tumour in mPCa, but to date, no randomised-controlled-trials (RCTs) have been published addressing this issue.Objective
To determine whether overall survival is prolonged by adding local treatment of the primary prostatic tumour with external beam radiation therapy (EBRT) to ADT.Design, setting, and participants
The HORRAD trial is a multicentre RCT recruiting 432 patients with prostate-specific antigen (PSA) >20 ng/ml and primary bone mPCa on bone scan between 2004 and 2014.Intervention
Patients were randomised to either ADT with EBRT (radiotherapy group) or ADT alone (control group).Outcome measurements and statistical analysis
Primary endpoint was overall survival. Secondary endpoint was time to PSA progression. Crude and adjusted analyses were applied to evaluate treatment effect.Results and limitations
Median PSA level was 142 ng/ml and 67% of patients had more than five osseous metastases. Median follow up was 47 mo. Median overall survival was 45 mo (95% confidence interval [CI], 40.4–49.6) in the radiotherapy group and 43 mo (95% CI: 32.6–53.4) in the control group (p = 0.4). No significant difference was found in overall survival (hazard ratio [HR]: 0.90; 95% CI: 0.70–1.14; p = 0.4). Median time to PSA progression in the radiotherapy group was 15 mo (95% CI: 11.8–18.2), compared with 12 mo (95% CI: 10.6–13.4) in the control group. The crude HR (0.78; 95% CI: 0.63–0.97) was statistically significant (p = 0.02).Conclusions
The current RCT comparing ADT to ADT with EBRT to the prostate in patients with primary bone mPCa did not show a significant difference in overall survival, although the CI cannot exclude a substantial survival benefit. Further research is needed to confirm our findings.Patient summary
This study investigated the effect of adding radiation therapy to the prostate to hormonal therapy in prostate cancer patients with metastasis to the bone at diagnosis. In our patient group, additional radiotherapy did not improve overall survival. Further research is needed to confirm our findings.Twitter summary
Adding radiotherapy to the prostate in patients with bone metastatic prostate cancer does not improve overall survival. 相似文献12.
John D. Kelly Wei Shen Tan Nuria Porta Hugh Mostafid Robert Huddart Andrew Protheroe Richard Bogle Jane Blazeby Alison Palmer Jo Cresswell Mark Johnson Richard Brough Sanjeev Madaan Stephen Andrews Clare Cruickshank Stephanie Burnett Lauren Maynard Emma Hall 《European urology》2019,75(4):593-601
Background
Non–muscle-invasive bladder cancer (NMIBC) has a significant risk of recurrence despite adjuvant intravesical therapy.Objective
To determine whether celecoxib, a cyclo-oxygenase 2 inhibitor, reduces the risk of recurrence in NMIBC patients receiving standard treatment.Design, setting, and participants
BOXIT (CRUK/07/004, ISRCTN84681538) is a double-blinded, phase III, randomised controlled trial. Patients aged ≥18 yr with intermediate- or high-risk NMIBC were accrued across 51 UK centres between 1 November 2007 and 23 July 2012.Intervention
Patients were randomised (1:1) to celecoxib 200 mg twice daily or placebo for 2 yr. Patients with intermediate-risk NMIBC were recommended to receive six weekly mitomycin C instillations; high-risk NMIBC cases received six weekly bacillus Calmette-Guérin and maintenance therapy.Outcome measurements and statistical analysis
The primary endpoint was time to disease recurrence. Analysis was by intention to treat.Results and limitations
A total of 472 patients were randomised (236:236). With median follow-up of 44 mo (interquartile range: 36–57), 3-yr recurrence-free rate (95% confidence interval) was as follows: celecoxib 68% (61–74%) versus placebo 64% (57–70%; hazard ratio [HR] 0.82 [0.60–1.12], p = 0.2). There was no difference in high-risk (HR 0.77 [0.52–1.15], p = 0.2) or intermediate-risk (HR 0.90 [0.55–1.48], p = 0.7) NMIBC. Subgroup analysis suggested that time to recurrence was longer in pT1 NMIBC patients treated with celecoxib compared with those receiving placebo (HR 0.53 [0.30–0.94], interaction test p = 0.04). The 3-yr progression rates in high-risk patients were low: 10% (6.5–17%) and 9.7% (6.0–15%) in celecoxib and placebo arms, respectively. Incidence of serious cardiovascular events was higher in celecoxib (5.2%) than in placebo (1.7%) group (difference +3.4% [–0.3% to 7.2%], p = 0.07).Conclusions
BOXIT did not show that celecoxib reduces the risk of recurrence in intermediate- or high-risk NMIBC, although celecoxib was associated with delayed time to recurrence in pT1 NMIBC patients. The increased risk of cardiovascular events does not support the use of celecoxib.Patient summary
Celecoxib was not shown to reduce the risk of recurrence in intermediate- or high-risk non–muscle-invasive bladder cancer (NMIBC), although celecoxib was associated with delayed time to recurrence in pT1 NMIBC patients. The increased risk of cardiovascular events does not support the use of celecoxib. 相似文献13.
Jürgen E. Gschwend Matthias M. Heck Jan Lehmann Herbert Rübben Peter Albers Johannes M. Wolff Detlef Frohneberg Patrick de Geeter Axel Heidenreich Tilman Kälble Michael Stöckle Thomas Schnöller Arnulf Stenzl Markus Müller Michael Truss Stephan Roth Uwe-Bernd Liehr Joachim Leißner Margitta Retz 《European urology》2019,75(4):604-611
Background
The extent of lymph node dissection (LND) in bladder cancer (BCa) patients at the time of radical cystectomy may affect oncologic outcome.Objective
To evaluate whether extended versus limited LND prolongs recurrence-free survival (RFS).Design, setting, and participants
Prospective, multicenter, phase-III trial patients with locally resectable T1G3 or muscle-invasive urothelial BCa (T2-T4aM0).Intervention
Randomization to limited (obturator, and internal and external iliac nodes) versus extended LND (in addition, deep obturator, common iliac, presacral, paracaval, interaortocaval, and para-aortal nodes up to the inferior mesenteric artery).Outcome measurements and statistical analysis
The primary endpoint was RFS. Secondary endpoints included cancer-specific survival (CSS), overall survival (OS), and complications. The trial was designed to show 15% advantage of 5-yr RFS by extended LND.Results and limitations
In total, 401 patients were randomized from February 2006 to August 2010 (203 limited, 198 extended). The median number of dissected nodes was 19 in the limited and 31 in the extended arm. Extended LND failed to show superiority over limited LND with regard to RFS (5-yr RFS 65% vs 59%; hazard ratio [HR] = 0.84 [95% confidence interval 0.58–1.22]; p = 0.36), CSS (5-yr CSS 76% vs 65%; HR = 0.70; p = 0.10), and OS (5-yr OS 59% vs 50%; HR = 0.78; p = 0.12). Clavien grade ≥3 lymphoceles were more frequently reported in the extended LND group within 90 d after surgery. Inclusion of T1G3 tumors may have contributed to the negative study result.Conclusions
Extended LND failed to show a significant advantage over limited LND in RFS, CSS, and OS. A larger trial is required to determine whether extended compared with limited LND leads to a small, but clinically relevant, survival difference (ClinicalTrials.gov NCT01215071).Patient summary
In this study, we investigated the outcome in bladder cancer patients undergoing cystectomy based on the anatomic extent of lymph node resection. We found that extended removal of lymph nodes did not reduce the rate of tumor recurrence in the expected range. 相似文献14.
Olivier Wegelin Leonie Exterkate Marloes van der Leest Jean A. Kummer Willem Vreuls Peter C. de Bruin J.L.H.Ruud Bosch Jelle O. Barentsz Diederik M. Somford Harm H.E. van Melick 《European urology》2019,75(4):582-590
Background
Guidelines advise multiparametric magnetic resonance imaging (mpMRI) before repeat biopsy in patients with negative systematic biopsy (SB) and a suspicion of prostate cancer (PCa), enabling MRI targeted biopsy (TB). No consensus exists regarding which of the three available techniques of TB should be preferred.Objective
To compare detection rates of overall PCa and clinically significant PCa (csPCa) for the three MRI-based TB techniques.Design, setting, and participants
Multicenter randomised controlled trial, including 665 men with prior negative SB and a persistent suspicion of PCa, conducted between 2014 and 2017 in two nonacademic teaching hospitals and an academic hospital.Intervention
All patients underwent 3-T mpMRI evaluated with Prostate Imaging Reporting and Data System (PIRADS) version 2. If imaging demonstrated PIRADS ≥3 lesions, patients were randomised 1:1:1 for one TB technique: MRI-transrectal ultrasound (TRUS) fusion TB (FUS-TB), cognitive registration TRUS TB (COG-TB), or in-bore MRI TB (MRI-TB).Outcome measurements and statistical analysis
Primary (overall PCa detection) and secondary (csPCa detection [Gleason score ≥3 + 4]) outcomes were compared using Pearson chi-square test.Results and limitations
On mpMRI, 234/665 (35%) patients had PIRADS ≥3 lesions and underwent TB. There were no significant differences in the detection rates of overall PCa (FUS-TB 49%, COG-TB 44%, MRI-TB 55%, p = 0.4). PCa detection rate differences were ?5% between FUS-TB and MRI-TB (p = 0.5, 95% confidence interval [CI] ?21% to 11%), 6% between FUS-TB and COG-TB (p = 0.5, 95% CI ?10% to 21%), and ?11% between COG-TB and MRI-TB (p = 0.17, 95% CI ?26% to 5%). There were no significant differences in the detection rates of csPCa (FUS-TB 34%, COG-TB 33%, MRI-TB 33%, p > 0.9). Differences in csPCa detection rates were 2% between FUS-TB and MRI-TB (p = 0.8, 95% CI ?13% to 16%), 1% between FUS-TB and COG-TB (p > 0.9, 95% CI ?14% to 16%), and 1% between COG-TB and MRI-TB (p > 0.9, 95% CI ?14% to 16%). The main study limitation was a low rate of PIRADS ≥3 lesions on mpMRI, causing underpowering for primary outcome.Conclusions
We found no significant differences in the detection rates of (cs)PCa among the three MRI-based TB techniques.Patient summary
In this study, we compared the detection rates of (aggressive) prostate cancer among men with prior negative biopsies and a persistent suspicion of cancer using three different techniques of targeted biopsy based on magnetic resonance imaging. We found no significant differences in the detection rates of (aggressive) prostate cancer among the three techniques. 相似文献15.
Aly-Khan A. Lalani Bradley A. McGregor Laurence Albiges Toni K. Choueiri Robert Motzer Thomas Powles Christopher Wood Axel Bex 《European urology》2019,75(1):100-110
Context
Systemic therapy for metastatic clear cell renal cell carcinoma (mccRCC) has greatly evolved over the last 15 yr. More recently, combination strategies involving contemporary immunotherapy have emerged as key opportunities to further shift the treatment landscape.Objective
To review the evidence regarding the efficacy and safety of standard therapeutic options in mccRCC as well as combination immunotherapy options on the horizon.Evidence acquisition
PubMed/Medline, Embase, Web of Knowledge, and Cochrane Library databases were searched up to February 2018 and according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. A narrative review of studies was performed.Evidence synthesis
Twenty-six studies were included regarding therapies for metastatic RCC including vascular endothelial growth factor (VEGF)-directed therapy (n = 9), mTOR inhibitors (n = 2), cytokines (n = 3), vaccines (n = 3), and immune checkpoint inhibitors (ICIs, n = 9). VEGF tyrosine kinase inhibitor monotherapy had been the standard therapy, and its use is evolving in the front-line setting with ICIs; cabozantinib provides superior progression-free survival versus sunitinib in intermediate- and poor-risk patients, by International Metastatic RCC Database Consortium criteria. The mTOR therapy is largely inferior to VEGF-directed therapy, although it has a role in combination strategies. Cytokines have largely been replaced in current practice throughout most regions, and vaccines have failed to show improved survival in phase III studies to date. ICIs have now become standard care in untreated patients with intermediate and poor risks, given overall survival benefit seen with CheckMate-214 study; survival data from IMmotion 151 are not yet mature. Several ongoing phase III combination trials, with promising early-phase data, are due to be read out.Conclusions
The treatment landscape for mccRCC has evolved since the introduction of VEGF inhibitors. Combination therapies involving checkpoint inhibitors could be the next standard of care.Patient summary
With the expanding role of immune checkpoint inhibitors in metastatic renal cell carcinoma, the treatment paradigm has shifted to include combination therapy in the untreated setting. As the field advances, the bar has been raised in evaluating ongoing combination strategies. 相似文献16.
Sami Hamid Ian A. Donaldson Yipeng Hu Rachael Rodell Barbara Villarini Ester Bonmati Pamela Tranter Shonit Punwani Harbir S. Sidhu Sarah Willis Jan van der Meulen David Hawkes Neil McCartan Ingrid Potyka Norman R. Williams Chris Brew-Graves Alex Freeman Caroline M. Moore Hashim U. Ahmed 《European urology》2019,75(5):733-740
Background
Multiparametric magnetic resonance imaging (mpMRI)-targeted prostate biopsies can improve detection of clinically significant prostate cancer and decrease the overdetection of insignificant cancers. It is unknown whether visual-registration targeting is sufficient or augmentation with image-fusion software is needed.Objective
To assess concordance between the two methods.Design, setting, and participants
We conducted a blinded, within-person randomised, paired validating clinical trial. From 2014 to 2016, 141 men who had undergone a prior (positive or negative) transrectal ultrasound biopsy and had a discrete lesion on mpMRI (score 3–5) requiring targeted transperineal biopsy were enrolled at a UK academic hospital; 129 underwent both biopsy strategies and completed the study.Intervention
The order of performing biopsies using visual registration and a computer-assisted MRI/ultrasound image-fusion system (SmartTarget) on each patient was randomised. The equipment was reset between biopsy strategies to mitigate incorporation bias.Outcome measurements and statistical analysis
The proportion of clinically significant prostate cancer (primary outcome: Gleason pattern ≥3 + 4 = 7, maximum cancer core length ≥4 mm; secondary outcome: Gleason pattern ≥4 + 3 = 7, maximum cancer core length ≥6 mm) detected by each method was compared using McNemar's test of paired proportions.Results and limitations
The two strategies combined detected 93 clinically significant prostate cancers (72% of the cohort). Each strategy detected 80/93 (86%) of these cancers; each strategy identified 13 cases missed by the other. Three patients experienced adverse events related to biopsy (urinary retention, urinary tract infection, nausea, and vomiting). No difference in urinary symptoms, erectile function, or quality of life between baseline and follow-up (median 10.5 wk) was observed. The key limitations were lack of parallel-group randomisation and a limit on the number of targeted cores.Conclusions
Visual-registration and image-fusion targeting strategies combined had the highest detection rate for clinically significant cancers. Targeted prostate biopsy should be performed using both strategies together.Patient summary
We compared two prostate cancer biopsy strategies: visual registration and image fusion. A combination of the two strategies found the most clinically important cancers and should be used together whenever targeted biopsy is being performed. 相似文献17.
Byung-Ki Cho Ji-Kang Park Seung-Myung Choi Nelson F. SooHoo 《Foot and Ankle Surgery》2019,25(2):127-131
Background
This study was performed to evaluate the intermediate-term clinical outcomes after proximal chevron osteotomy for hallux valgus in patients with generalized ligamentous laxity, and to determine the effect on postoperative recurrence of deformity.Methods
There were 23 cases in laxity group (Beighton score ≥5 points) and 175 in non-laxity group with a mean followup of 46.3 months. Clinical evaluation consisted of the AOFAS score, Foot and Ankle Ability Measure (FAAM), and radiographic measurement of hallux alignment. Risk factors associated with postoperative recurrence were evaluated using univariate analysis.Results
Recurrence rates were 21.7% in the laxity group and 17.1% in non-laxity group (P = .218). There were no significant differences in clinical and radiographic measurements at final followup between the 2 groups. Preoperative HVA and IMA were found to be predictive factors of recurrence (OR = 6.3, 4.2; P = .001, .018, respectively).Conclusion
There were no statistical differences in the clinical and radiographic outcomes between hallux valgus with and without generalized ligamentous laxity. Generalized ligamentous laxity demonstrated no definitive effects on postoperative recurrence of hallux valgus deformity. 相似文献18.
Panagiotis Touzopoulos Athanasios Ververidis Giannis Giakas Georgios I. Drosos 《Foot and Ankle Surgery》2019,25(1):8-12
Background
The purpose of this study was the translation, cross-cultural adaptation and validation of the Achilles Tendon Total Rupture Score (ATRS) in Greek population.Methods
The translation and cross-cultural adaptation of the original version of ATRS in Greek language was performed according to the methodology described by Beaton et al. Validation and test–retest reliability were evaluated in forty-six patients, treated surgically for acute Achilles tendon rupture. Validity was evaluated by correlation of total and all subscale scores of Greek version of Manchester Foot Pain and Disability Index (MFPDI). Test–retest reliability evaluated with interclass correlation coefficient and Crombach’s α coefficient was used for internal consistency.Results
The internal consistency (α = 0.96) and test–retest reliability (ICC = 0.97) were excellent. There were no ceiling and floor effects during test–retest assessment. The Greek version of ATRS showed strong correlation with all subscales and overall score of MFPDI (pain subscale: R = ?0.954, p < 0.01, function subscale: R = ?0.811, p < 0.01, appearance subscale: R = ?0.763, p < 0.01, overall: R = ?0.914, p < 0.01).Conclusions
Greek version of ATRS was successfully adapted in Greek population and it appears to be a valid and reliable instrument to evaluate outcomes in Greek speaking patients after Achilles tendon rupture.Level of evidence
Level III. 相似文献19.
José Antonio Pereira Miguel Pera Manuel López-Cano Marta Pascual Sandra Alonso Silvia Salvans Marta Jiménez-Toscano Alba González-Martín Luis Grande-Posa 《Cirugía espa?ola》2019,97(1):20-26
Objectives
To determine the incidence of incisional hernia (IH) in the extraction incision (EI) in colorectal resection for cancer. To analyze whether the location of the incision has any relationship with the incidence of hernias and whether mesh could be useful for prevention in high-risk patients.Methods
Retrospective review of the colon and rectal surgery database from January 2015 to December 2016. Data were classified into 2 groups, transverse (TI) and midline incision (MI), and the latter was divided into 2 subgroups (mesh [MIM] and suture [MIS]). Patients were classified using the HERNIAscore. Hernias were diagnosed by clinical and/or CT examination.Results
A total of 182 out of 210 surgical patients were included. After a median follow-up of 13.0 months, 39 IH (21.9%) were detected, 23 of which (13.4%) were in the EI; their frequency was lower in the TI group (3.4%) and in the MIM group (5.9%) than in the MIS group (29.5%; p = 0.007). The probability of developing IH in the MIS group showed an OR = 11.7 (95%CI: 3.3-42.0) compared to the TI group and 4.3 (IC 95%: 1.1-16.3) versus the MIM group.Conclusions
The location of the incision is relevant to avoid incisional hernias. Transverse incisions should be used as the first option. When a midline incision is needed, a prophylactic mesh could be considered in high risk patients because it is safe and associated with low morbidity. 相似文献20.
J. Caño-Velasco F. Herranz-Amo G. Barbas-Bernardos L. Polanco-Pujol E. Lledó-García C. Hernández-Fernández 《Actas urologicas espa?olas》2019,43(1):18-25