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1.

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   

2.

Background

Current literature on carbon fiber implant use in foot and ankle surgery is scant. The purpose of this paper is to report medium-term outcomes of hindfoot fusion using a carbon fiber intramedullary nail.

Methods

We retrospectively reviewed 30 cases of hindfoot fusion using carbon fiber intramedullary nail fixation between 2014 and 2017. We excluded revisions and cases with bulk allograft or ankle infection prior to surgery. We reviewed charts for length of followup, radiographic union, and complications.

Results

Eleven patients were included (6 females, 5 males; mean age = 52 ± 15 years; mean BMI = 29.0 ± 6.4 kg/m2). Mean followup was 20 (range, 1.5–107) months. Nine of eleven cases achieved radiographic union while one case developed a complication requiring surgery. The mean time to union was 3 (range, 1.5–6) months.

Conclusions

Carbon fiber implants offer several theoretical advantages over traditional metallic implants. They can be used safely in foot and ankle surgery without concern for high failure or complication rate. Larger scale studies with longer followup are needed on this topic.  相似文献   

3.

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   

4.

Background

To obtain adequate fixation in treating Lisfranc soft tissue injuries, the joint is commonly stabilized using multiple transarticular screws; however iatrogenic injury is a concern. Alternatively, two parallel, longitudinally placed plates, can be used to stabilize the 1st and 2nd tarsometatarsal joints; however this may not provide adequate stability along the Lisfranc ligament. Several biomechanical studies have compared earlier methods of fixation using plates to the standard transarticular screw fixation method, highlighting the potential issue of transverse stability using plates. A novel dorsal plate is introduced, intended to provide transverse and longitudinal stability, without injury to the articular cartilage.

Methods

A biomechanical cadaver model was developed to compare the fixation stability of a novel Lisfranc plate to that of traditional fixation, using transarticular screws. Thirteen pairs of cadaveric specimens were tested intact, after a simulated Lisfranc injury, and then following implant fixation, using one method of fixation randomly assigned, on either side of each pair. Optical motion tracking was used to measure the motion between each of the following four bones: 1st metatarsal, 2nd metatarsal, 1st cuneiform, and 2nd cuneiform. Testing included both cyclic abduction loading and cyclic axial loading.

Results

Both the Lisfranc plate and screw fixation method provided stability such that the average 3D motions across the Lisfranc joint (between 2nd metatarsal and 1st cuneiform), were between 0.2 and 0.4 mm under cyclic abduction loading, and between 0.4 and 0.5 mm under cyclic axial loading. Comparing the stability of fixation between the Lisfranc plate and the screws, the differences in motion were all 0.3 mm or lower, with no clinically significant differences (p > 0.16).

Conclusions

Diastasis at the Lisfranc joint following fixation with a novel plate or transarticular screw fixation were comparable. Therefore, the Lisfranc plate may provide adequate support without risk of iatrogenic injury to the articular cartilage.  相似文献   

5.

Background

Periprosthetic cystic osteolysis is a well-known complication of total ankle replacement. Several theories have been proposed for its aetiology, based on individual biomechanical, radiological, histopathology and outcome studies.

Methods

Studies that met predefined inclusion/exclusion criteria were analysed to identify literature describing the presence of peri-prosthetic ankle cystic osteolysis. Quantitative data from the selected articles were combined and statistically tested in order to analyse possible relations between ankle peri-prosthetic bone cysts and specific implant characteristics.

Results

Twenty-one articles were elected, totalizing 2430 total ankle replacements, where 430 developed peri-prosthetic cystic osteolysis.A statistically significant association (P < .001) was found between the presence of bone cysts and non-anatomic implant configuration, hydroxyapatite-coating, mobile-bearing and non tibial-stemmed implants. No significant association existed between the type of constraining and the presence of cysts (P > .05).

Conclusions

Non-anatomic, mobile-bearing, hydroxyapatite-coated and non tibial-stemmed total ankle replacements are positively associated with more periprosthetic bone cysts.  相似文献   

6.

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   

7.

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   

8.

Context

The optimal treatment of urothelial bladder cancer (UBC) with micropapillary (MP) variant histology is not clear.

Objective

To review the current literature on disease characteristics and treatment outcomes of MP UBC.

Evidence acquisition

A systematic search was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the Cochrane Handbook for Systematic Reviews of Interventions. The primary end points were recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS).

Evidence synthesis

We identified 758 reports comprising a total of 3154 patients, of which 28 and 15 articles were selected for qualitative and quantitative analysis, respectively. In patients with T1 MP UBC, the 5-yr CSS rates for early radical cystectomy (RC) ranged from 81% to 100%, while they were between 60% and 85% for transurethral resection of the bladder and Bacillus Calmette-Guérin (BCG). In studies reporting on neoadjuvant chemotherapy (NAC), the rates of complete pathological response (ypT0) ranged from 11% to 55%. Nevertheless, the use of NAC did not improve RFS (hazard ratio [HR] 1.23, 95% confidence interval [CI] 0.52–2.93, p = 0.6), CSS (HR 0.9, 95% CI 0.48–1.7, p = 0.8), or OS (HR 1.35, 95% CI 0.98–1.86, p = 0.1). Fifty-three percent (95% CI 43–63%) of patients who underwent RC alone had locally advanced disease (≥pT3), and 43% (95% CI 33–52%) were harbouring lymph node metastases. MP component at RC was not significantly associated with worse RFS (HR 1.25, 95% CI 0.88–1.78, p = 0.2), CSS (HR 0.96, 95% CI 0.57–1.6, p = 0.9), or OS (HR 1.20, 95% CI 0.88–1.62, p = 0.3) when adjusted for pathological features.

Conclusions

While MP UBC is associated with clinicopathological features of advanced disease, it is not associated with worse survival outcomes in patients undergoing RC. NAC results in pathological downstaging in a significant number of patients. Nevertheless, this does not translate into better survival outcomes. The optimal treatment of patients with cT1 remains controversial.

Patient summary

Our results suggest that micropapillary urothelial bladder cancer does not necessarily mandate different treatment algorithms. Nevertheless, each case should be discussed individually considering other clinicopathological factors.  相似文献   

9.

Background

Some studies suggest that gonadotropin-releasing hormone (GnRH) agonists are associated with higher risk of adverse events than antiandrogens (AAs) monotherapy. However, it has been unclear whether this is due to indication bias.

Objective

To investigate rates of change in comorbidity for men on GnRH agonists versus AA monotherapy in a population-based register study.

Design, setting, and participants

Men with advanced nonmetastatic prostate cancer (PCa) who received primary AA (n = 2078) or GnRH agonists (n = 4878) and age- and area-matched PCa-free men were selected from Prostate Cancer Database Sweden 3.0. Increases in comorbidity were measured using the Charlson Comorbidity Index (CCI), from 5 yr before through to 5 yr after starting androgen deprivation therapy (ADT).

Outcome measures and statistical methods

Multivariable linear regression was used to determine differences in excess rate of CCI change before and after ADT initiation. Risk of any incremental change in CCI following ADT was assessed using multivariable Cox regression analyses.

Results and limitations

Men on GnRH agonists experienced a greater difference in excess rate of CCI change after starting ADT than men on AA monotherapy (5.6% per yr, p < 0.001). Risk of any new CCI change after ADT was greater for GnRH agonists than for AA (hazard ratio, 1.32; 95% confidence interval, 1.20–1.44).

Conclusions

Impact on comorbidity was lower for men on AA monotherapy than for men on GnRH agonists. Our results should be confirmed through randomised trials of effectiveness and adverse effects, comparing AA monotherapy and GnRH agonists in men with advanced nonmetastatic PCa who are unsuitable for curative treatment.

Patient summary

Hormone therapies for advanced prostate cancer can increase the risk of other diseases (eg, heart disease, diabetes). This study compared two common forms of hormone therapy and found that the risk of another serious disease was higher for those on gonadotropin-releasing hormone agonists than for those on antiandrogen monotherapy.  相似文献   

10.

Background

Understanding physician-level discrepancies is increasingly a target of US healthcare reform for the delivery of quality-focused patient care.

Objective

To estimate the relative contributions of patient and surgeon characteristics to the variability in key outcomes after partial nephrectomy (PN).

Design, setting, and participants

Retrospective review of 1461 patients undergoing PN performed by 19 surgeons between 2011 and 2016 at a tertiary care referral center.

Intervention

PN for a renal mass.

Outcomes measurements and statistical analysis

Hierarchical linear and logistic regression models were built to determine the percentage variability contributed by fixed patient and surgeon factors on peri- and postoperative outcomes. Residual between- and within-surgeon variability was calculated while adjusting for fixed factors.

Results and limitations

On null hierarchical models, there was significant between-surgeon variability in operative time, estimated blood loss (EBL), ischemia time, excisional volume loss, length of stay, positive margins, Clavien complications, and 30-d readmission rate (all p < 0.001), but not chronic kidney disease upstaging (p = 0.47) or percentage preservation of glomerular filtration rate (p = 0.49). Patient factors explained 82% of the variability in excisional volume loss and 0–32% of the variability in the remainder of outcomes. Quantifiable surgeon factors explained modest amounts (10–40%) of variability in intraoperative outcomes, and noteworthy amounts of variability (90–100%) in margin rates and patient morbidity outcomes. Immeasurable surgeon factors explained the residual variability in operative time (27%), EBL (6%), and ischemia time (31%).

Conclusions

There is significant between-surgeon variability in outcomes after PN, even after adjusting for patient characteristics. While renal functional outcomes are consistent across surgeons, measured and unmeasured surgeon factors account for 18–100% of variability of the remaining peri- and postoperative variables. With the increasing utilization of value-based medicine, this has important implications for the goal of optimizing patient care.

Patient summary

We reviewed our institutional database on partial nephrectomy performed for renal cancer. We found significant variability between surgeons for key outcomes after the intervention, even after adjusting for patient characteristics.  相似文献   

11.

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   

12.

Background

The homeobox B13 (HOXB13) G84E mutation has been recommended for use in genetic counselling for prostate cancer (PCa), but the magnitude of PCa risk conferred by this mutation is uncertain.

Objective

To obtain precise risk estimates for mutation carriers and information on how these vary by family history and other factors.

Design, setting, and participants

Two-fold: a systematic review and meta-analysis of published risk estimates, and a kin-cohort study comprising pedigree data on 11 983 PCa patients enrolled during 1993–2014 from 189 UK hospitals and who had been genotyped for HOXB13 G84E.

Outcome measurements and statistical analysis

Relative and absolute PCa risks. Complex segregation analysis with ascertainment adjustment to derive age-specific risks applicable to the population, and to investigate how these vary by family history and birth cohort.

Results and limitations

A meta-analysis of case-control studies revealed significant heterogeneity between reported relative risks (RRs; range: 0.95–33.0, p < 0.001) and differences by case selection (p = 0.007). Based on case-control studies unselected for PCa family history, the pooled RR estimate was 3.43 (95% confidence interval [CI] 2.78–4.23). In the kin-cohort study, PCa risk for mutation carriers varied by family history (p < 0.001). There was a suggestion that RRs decrease with age, but this was not significant (p = 0.068). We found higher RR estimates for men from more recent birth cohorts (p = 0.004): 3.09 (95% CI 2.03–4.71) for men born in 1929 or earlier and 5.96 (95% CI 4.01–8.88) for men born in 1930 or later. The absolute PCa risk by age 85 for a male HOXB13 G84E carrier varied from 60% for those with no PCa family history to 98% for those with two relatives diagnosed at young ages, compared with an average risk of 15% for noncarriers. Limitations include the reliance on self-reported cancer family history.

Conclusions

PCa risks for HOXB13 G84E mutation carriers are heterogeneous. Counselling should not be based on average risk estimates but on age-specific absolute risk estimates tailored to individual mutation carriers’ family history and birth cohort.

Patient summary

Men who carry a hereditary mutation in the homeobox B13 (HOXB13) gene have a higher than average risk for developing prostate cancer. In our study, we examined a large number of families of men with prostate cancer recruited across UK hospitals, to assess what other factors may contribute to this risk and to assess whether we could create a precise model to help in predicting a man's prostate cancer risk. We found that the risk of developing prostate cancer in men who carry this genetic mutation is also affected by a family history of prostate cancer and their year of birth. This information can be used to assess more personalised prostate cancer risks to men who carry HOXB13 mutations and hence better counsel them on more personalised risk management options, such as tailoring prostate cancer screening frequency.  相似文献   

13.

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   

14.

Background

Postoperative pain is the most common postoperative complication. This study was conducted to assess the effect of acetaminophen versus fentanyl on postoperative pain relief in patients who underwent urologic surgeries.

Methods

This clinical trial was conducted on patients aged 18–65 years. Patients were randomly assigned to receive either 2000 mg acetaminophen (propacetamol) or 2 mcg.kg?1 fentanyl intravenously, 15 min before the end of surgery. The postoperative pain was evaluated every 6 h for 24 h using the Visual Analog Scale. Total morphine dose taken in 24 h and hemodynamic status were evaluated.

Results

Eighty patients were enrolled into the trial. The mean score of pain in 6, 12, 18, and 24 h after surgery was lower in the acetaminophen group than in the fentanyl group but the difference was not statistically significant except in 12 and 18 h after surgery (p < 0.05). The amount of administered morphine was higher in the fentanyl group than in the acetaminophen group, but the difference was not statistically significant. The hemodynamic status including systolic and diastolic blood pressure and heart rates were nearly the same in the two groups but the SpO2 mean was significantly higher in the acetaminophen group than the fentanyl group.

Conclusions

This trial indicated that intravenous acetaminophen is as effective as intravenous fentanyl in pain relief after urologic surgeries (transurethral lithotripsy).  相似文献   

15.

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   

16.

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.

Background

The primary aim of this study was to present the incidence of clinically significant end stage osteoarthritis (cOA) after syndesmotic fixation of ankle fractures. The secondary aim was to and identify independent predictors of cOA.

Methods

A retrospective review of consecutive patients presenting to a single University affiliated institution between March 2008 and May 2010 was undertaken. Inclusion criteria were ankle fractures with syndesmotic stabilisation. Patients were excluded if pre or postoperative radiographs were missing or were lost to follow up. Data were gathered regarding demographics, fracture pattern, fixation methods, reduction parameters, screw removal, revision surgery, complications and cOA up to seven years post injury.

Results

Data were available for 120 patients (86%). In total, 13 patients (11%) developed cOA. Univariate analysis showed that increasing age, open fracture, malreduction of the syndesmosis, removal of symptomatic screws, revision surgery and complications were predictors of developing cOA. Cox regression analysis revealed increasing age (hazard ratio (HR) 1.09, p = 0.006), and malreduction (HR 45.5, p = 0.001) were independent predictors of developing cOA.

Conclusions

Ankle fractures with syndesmotic stabilisation represent a severe injury with a high rate of cOA. The only modifiable risk factor for developing cOA in this large series of patients was radiological malalignment. When syndesmotic stabilisation is required, careful intraoperative assessment should be undertaken to ensure the syndesmosis is reduced.  相似文献   

18.

Background

We report our experience with the Minimally Invasive Chevron Akin (MICA) technique for correcting hallux valgus, and evaluate its effectiveness and associated complications.

Methods

Case series of 13 feet with mild to moderate symptomatic hallux valgus treated surgically from July 2013 to December 2014, with at least 48-months follow-up. Patients were assessed pre-operatively and post-operatively with radiographical measurements (Hallux Valgus Angle (HVA) and Intermetatarsal Angle (IMA)) and clinical scores (American Orthopaedic Foot and Ankle Society (AOFAS), 36-Item Short Form Health Survery (SF-36), Visual Analog Scale (VAS)).

Results

Mean HVA and IMA decreased from 30.4° and 13.9°–10.9° and 10.2° respectively (p < 0.05). The mean AOFAS score improved from an average of 59.0–93.7 (p < 0.05). All patients reported a VAS score of 0 post-operatively, and the 4 SF-36 domains improved significantly (p < 0.05).

Conclusions

The MICA technique is a safe and effective method in the surgical correction of mild to moderate hallux valgus deformity, and continued use is justified.  相似文献   

19.

Background

Hypothermia occurs in up to 20% of perioperative patients. Systematic postoperative temperature monitoring is not a standard of care in Brazil and there are few publications about temperature recovery in the postoperative care unit.

Design and setting

Multicenter, observational, cross‐sectional study, at Hospital de Base do Distrito Federal and Hospital Materno Infantil de Brasília.

Methods

At admission and discharge from postoperative care unit, patients undergoing elective or urgent surgical procedures were evaluated according to tympanic temperature, vital signs, perioperative adverse events, and length of stay in postoperative care unit and length of hospital stay.

Results

78 patients, from 18 to 85 years old, were assessed. The incidence of temperatures <36 °C at postoperative care unit admission was 69.2%. Spinal anesthesia (p < 0.0001), cesarean section (p = 0.03), and patients who received morphine (p = 0.005) and sufentanil (p = 0.003) had significantly lower temperatures through time. During postoperative care unit stay, the elderly presented a greater tendency to hypothermia and lower recovery ability from this condition when compared to young patients (p < 0.001). Combined anesthesia was also associated to higher rates of hypothermia, followed by regional and general anesthesia alone (p < 0.001).

Conclusion

In conclusion, this pilot study showed that perioperative hypothermia is still a prevalent problem in our anesthetic practice. More than half of the analyzed patients presented hypothermia through postoperative care unit admission. We have demonstrated the feasibility of a large, multicenter, cross‐sectional study of postoperative hypothermia in the post‐anesthetic care unit.  相似文献   

20.

Background

Glutamine addiction is a hallmark of clear cell renal cell carcinoma (ccRCC); yet whether glutamine metabolism impacts local immune surveillance is unclear. This knowledge may yield novel immunotherapeutic opportunities.

Objective

To seek a potential therapeutic target in glutamine-addicted ccRCC.

Design, setting, and participants

Tumors from ccRCC patients from a Shanghai cohort and ccRCC tumor data from The Cancer Genome Atlas (TCGA) cohort were analyzed. In vivo and in vitro studies were conducted with fresh human ccRCC tumors and murine tumor cells.

Outcome measurements and statistical analysis

Immune cell numbers and functions were analyzed by flow cytometry. Glutamine and cytokine concentrations were determined. Survival was compared between different subpopulations of patients using Kaplan-Meier and Cox regression analyses.

Results and limitations

We found that in ccRCC, high interleukin (IL)-23 expression was significantly associated with poor survival in both TCGA (overall survival [OS] hazard ratio [HR] = 2.04, cancer-specific survival [CSS] HR = 2.95; all p < 0.001) and Shanghai (OS HR = 2.07, CSS HR = 3.92; all p < 0.001) cohorts. IL-23 blockade prolongs the survival of tumor-bearing mice, promotes T-cell cytotoxicity in in vitro cultures of human ccRCC tumors, and augments the therapeutic benefits of anti-PD-1 antibodies. Mechanistically, glutamine consumption by ccRCC tumor cells results in the local deprivation of extracellular glutamine, which induces IL-23 secretion by tumor-infiltrating macrophages via the activation of hypoxia-inducible factor 1α (HIF1α). IL-23 activates regulatory T-cell proliferation and promotes IL-10 and transforming growth factor β expression, thereby suppressing tumor cell killing by cytotoxic lymphocytes. The positive correlations between glutamine metabolism, IL-23 levels, and Treg responses are confirmed in both TCGA cohort and tumors from Shanghai ccRCC patients. Study limitations include the unclear impacts of glutamine deprivation and IL-23 on other immune cells.

Conclusions

Macrophage-secreted IL-23 enhanced Treg functions in glutamine-addicted tumors; thus, IL-23 is a promising target for immunotherapy in ccRCC.

Patient summary

In this study, we analyzed the immune components in glutamine-addicted clear cell renal cell carcinoma (ccRCC) tumors from two patient cohorts and conducted both in vitro and in vivo studies. We found that ccRCC tumor cell-intrinsic glutamine metabolism orchestrates immune evasion via interleukin (IL)-23, and IL-23–high patients had significantly poorer survival than IL-23–low patients. IL-23 should thus be considered a therapeutic target in ccRCC, either alone or in combination with immune checkpoint inhibitors.  相似文献   

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