Prostate biopsy sepsis prevention: external validation of an alcohol needle washing protocol.

PURPOSE: Transrectal ultrasound-guided prostate biopsy (TRUS-Bx) is associated with a 1-8% risk of post-biopsy sepsis (PBS). A recent study described an isopropyl alcohol needle washing protocol that significantly decreased PBS rates. The current study examined the efficacy of this technique in our clinic population. MATERIALS AND METHODS: Data were reviewed for 1250 consecutive patients undergoing TRUS-Bx at the Charlie Norwood VA Medical Center from January 2017 to January 2023. Needle washing was adopted in February 2021. Complications occurring within 30 days after TRUS-Bx were recorded. RESULTS: There were 912 patients in group 1 (without needle washing) and 338 in group 2 (with needle washing). Groups had equivalent demographic features, and men of African descent comprised 70% of patients. Standard 12 core biopsies were done in 83% and 82% in groups 1 and 2, respectively (p = 0.788). Total complication rates were 4% and 2% in groups 1 and 2, respectively (p = 0.077). There were 13 sepsis events in group 1 (1.4%) and none in group 2 (p = 0.027). Clavien-Dindo Grade I-III complications occurred in 25 (2.7%) and 7 (2.1%) patients in groups 1 and 2, respectively (p = 0.505). Standard antibiotic prophylaxis (PO fluoroquinolone and IM gentamicin) was given in 80% and 86% of patients in groups 1 and 2, respectively (p = 0.030). Subset analysis limited to patients who received standard prophylaxis showed a significant difference in sepsis rates (1.5% vs 0%; p = 0.036). CONCLUSIONS: Adoption of isopropyl alcohol needle washing was associated with a significant decrease in PBS events.

Pudendal nerve block prior to inflatable penile prosthesis implantation: decreased intra-operative narcotic requirements.

The opioid epidemic has proven to be a public health crisis over the past two decades and efforts to decrease opioid exposure are sorely needed. Our objective was to determine whether pudendal nerve block utilization in the immediate pre-operative setting decreases intra-operative opioid analgesic requirements in veteran patients undergoing a primary inflatable penile prosthesis implantation. We performed a retrospective cohort analysis of all patients undergoing penile prosthesis implantation between January 2017 and July 2020 at the Charlie Norwood Veterans Affairs Medical Center in Augusta, GA. Univariable and multivariable gamma regression analyses were performed to evaluate the association between pudendal nerve block utilization and intra-operative opioid analgesic requirements. The study cohort consisted of 110 patients, 35 (31.8%) of whom underwent a pudendal nerve block. Median intra-operative opioid analgesic requirements were significantly lower in the pudendal nerve block group (16.3 versus 25.8 morphine milliequivalents, p = 0.037). Receipt of the nerve block was associated with significantly lower intra-operative opioid analgesic requirements on multivariable (coefficient 0.84, p = 0.038) regression analysis. There was no significant difference in post-operative opioid analgesic requirements (p = 0.18). In conclusion, pre-operative pudendal nerve blocks decrease intra-operative opioid analgesic requirements in veteran patients undergoing a primary inflatable penile prosthesis implantation.

Suspension of Oncology Randomized Clinical Trials during the COVID-19 Pandemic: A Cross-Sectional Evaluation of COVID-Related Suspensions.

We conducted a cross-sectional analysis of ClinicalTrials.gov-registered oncology randomized controlled trials between September 2019 and December 2021 to identify predictors of trial suspensions. The dataset included 1,183 oncology trials, of which 384 (32.5%) were suspended. COVID-19 accounted for 47 (12.2%) suspensions. Trials that were single center- or US-based had higher odds of COVID-19 (ORs: 3.85 and 2.48, 95% CIs: 1.60-11.50 and 1.28-4.93, respectively) or any-reason suspensions (ORs: 2.33 and 2.04, 95% CIs: 1.46-3.45 and 1.40-2.76, respectively). Phase two (OR 1.27), three (OR 6.45) and four trials (OR 11.5) had increased odds of COVID-19 suspensions, compared to phase one trials.

Transparency of racial participation reporting in randomized controlled trials of minimally invasive surgical techniques.

BACKGROUND: Enrolment of racial/ethnic minorities in randomized controlled trials (RCTs) has historically been poor, despite efforts at improving access to RCTs. Under-representation of racial/ethnic minorities limits the external validity and generalizability of trials. Our objective was to determine to what extent are published RCTs of minimally invasive surgical techniques reporting the racial composition of their study cohorts and to describe the racial composition of patients enrolled in these trials, where data were available. METHODS: EMBASE (OvidSP®), MEDLINE (OvidSP®), and Cochrane (Wiley®) databases were systematically searched from inception to December 22, 2017 to identify all RCTs comparing minimally invasive and classical surgical techniques. The Mann-Kendall trend test was used to evaluate reporting trends over the study period. Predictors of racial reporting were evaluated using logistic regression analyses. RESULTS: Our search strategy yielded 9,321 references of which 496 RCTs met our inclusion/exclusion criteria. Racial information was reported in 20 (4.03%) studies. There was no significant improvement in racial reporting over the study period (p for trend = 0.31). Of the 17 different patient populations accounting for the 20 RCTs, 14 (82.4%) originated from the USA. Multicenter RCTs had significantly increased likelihood of reporting racial composition of the patient cohort (odds ratio 5.10, p = 0.025). White/Caucasian patients accounted for 84.5% of the pooled patient population, with Black/African American, Asian and Latin/Hispanic patients accounting for 7.9%, 1.2%, and 2.1%, respectively. CONCLUSIONS: Among RCTs assessing minimally invasive surgical techniques over the past 30 years, data on included patients' race is poorly reported. In addition to important efforts to improve access to clinical trials for racial and ethnic minorities, efforts aimed at improving reporting and transparency of surgical RCTs are sorely needed.

Use of the Fractional Excretion of Urea in an Azotemic Nonoliguric State: Type 1 Cardiorenal Syndrome.

The fractional excretion of urea is a useful tool to evaluate renal function in oliguric states; however, it remains unexplored in nonoliguric states. We evaluated its use to predict responses in patients with type 1 cardiorenal syndrome. This was a prospective observational study of 116 patients with type 1 cardiorenal syndrome referred over a 4-year period. Fractional excretion of urea and sodium, ejection fraction, mean arterial pressure, age, sex, diabetes, brain natriuretic peptide (BNP), serum sodium and blood urea nitrogen were analyzed for effects upon serum creatinine and survival. Improvement of renal function correlated most significantly with FeUrea (P = 0.00001) followed by the FeNa (P = 0.005) but no other variable studied reached significance. Survival was best predicted by improvement of the serum creatinine at 24 h (P = 0.005) and 7 days after all inotropes were stopped (P = 0.001). A limitation of this study is that it cannot be extrapolated to all cardiorenal syndrome patients other than type 1. Also, the study was not randomized and those with potentially worse disease have had worse outcomes due merely to worse underlying disease. The success of the FeUrea may possibly be related to interference of dobutamine on creatinine levels. Despite being a nonoliguric state, the FeUrea appears to provide insight to those patients with type 1 cardiorenal syndrome whose renal function (as measured by serum creatinine) and survival might improve.