Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial.

BACKGROUND AND OBJECTIVE: The transrectal biopsy approach is traditionally used to detect prostate cancer. An alternative transperineal approach is historically performed under general anesthesia, but recent advances enable transperineal biopsy to be performed under local anesthesia. We sought to compare infectious complications of transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis. METHODS: We assigned biopsy-naïve participants to undergo transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis (rectal culture screening for fluoroquinolone-resistant bacteria and antibiotic targeting to culture and sensitivity results) through a multicenter, randomized trial. The primary outcome was post-biopsy infection captured by a prospective medical review and patient report on a 7-d survey. The secondary outcomes included cancer detection, noninfectious complications, and a numerical rating scale (0-10) for biopsy-related pain and discomfort during and 7-d after biopsy. KEY FINDINGS AND LIMITATIONS: A total of 658 participants were randomized, with zero transperineal versus four (1.4%) transrectal biopsy infections (difference -1.4%; 95% confidence interval [CI] -3.2%, 0.3%; p = 0.059). The rates of other complications were very low and similar. Importantly, detection of clinically significant cancer was similar (53% transperineal vs 50% transrectal, adjusted difference 2.0%; 95% CI -6.0, 10). Participants in the transperineal arm experienced worse periprocedural pain (0.6 adjusted difference [0-10 scale], 95% CI 0.2, 0.9), but the effect was small and resolved by 7-d. CONCLUSIONS AND CLINICAL IMPLICATIONS: Office-based transperineal biopsy is tolerable, does not compromise cancer detection, and did not result in infectious complications. Transrectal biopsy with targeted prophylaxis achieved similar infection rates, but requires rectal cultures and careful attention to antibiotic selection and administration. Consideration of these factors and antibiotic stewardship should guide clinical decision-making. PATIENT SUMMARY: In this multicenter randomized trial, we compare prostate biopsy infectious complications for the transperineal versus transrectal approach. The absence of infectious complications with transperineal biopsy without the use of preventative antibiotics is noteworthy, but not significantly different from transrectal biopsy with targeted antibiotic prophylaxis.

Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications.

INTRODUCTION: Approximately one million prostate biopsies are performed annually in the USA, and most are performed using a transrectal approach under local anaesthesia. The risk of postbiopsy infection is increasing due to increasing antibiotic resistance of rectal flora. Single-centre studies suggest that a clean, percutaneous transperineal approach to prostate biopsy may have a lower risk of infection. To date, there is no high-level evidence comparing transperineal versus transrectal prostate biopsy. We hypothesise that transperineal versus transrectal prostate biopsy under local anaesthesia has a significantly lower risk of infection, similar pain/discomfort levels and comparable detection of non-low-grade prostate cancer. METHODS AND ANALYSIS: We will perform a multicentre, prospective randomised clinical trial to compare transperineal versus transrectal prostate biopsy for elevated prostate-specific antigen in the first biopsy, prior negative biopsy and active surveillance biopsy setting. Prostate MRI will be performed prior to biopsy, and targeted biopsy will be conducted for suspicious MRI lesions in addition to systematic biopsy (12 cores). Approximately 1700 men will be recruited and randomised in a 1:1 ratio to transperineal versus transrectal biopsy. A streamlined design to collect data and to determine trial eligibility along with the two-stage consent process will be used to facilitate subject recruitment and retention. The primary outcome is postbiopsy infection, and secondary outcomes include other adverse events (bleeding, urinary retention), pain/discomfort/anxiety and critically, detection of non-low-grade (grade group ≥2) prostate cancer. ETHICS AND DISSEMINATION: The Institutional Review Board of the Biomedical Research Alliance of New York approved the research protocol (protocol number #18-02-365, approved 20 April 2020). The results of the trial will be presented at scientific conferences and published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT04815876.

An Enhanced Recovery After Surgery protocol for robotic-assisted laparoscopic nephrectomies utilizing a quadratus lumborum block.

Enhanced Recovery After Surgery (ERAS) protocols have been developed in several fields to reduce hospitalization lengths and overall costs. There have also been developments in multimodal analgesia methods to curtail opioid usage after surgery. Herein, we present the results of our initiation of an ERAS protocol for robotic-assisted laparoscopic partial and radical nephrectomies, employing a quadratus lumborum (QL) regional anesthetic block. We retrospectively reviewed 614 patients in our Institutional Review Board approved database who underwent robotic-assisted laparoscopic partial or radical nephrectomies from January 2017 to February 2020. An ERAS protocol utilizing multimodal analgesia (acetaminophen and gabapentin) and a QL block was developed and introduced in February 2019. We then compared the opioid consumption and perioperative outcomes of patients before and after ERAS protocol initiation. 192 ERAS patients (February 2019 to February 2020) were compared to 422 non-ERAS patients (January 2017 to January 2019). Baseline characteristics and the proportion of preoperative opioids users were similar between the two groups. There were no statistically significant differences in surgery length, hospitalization length, or complication rates. There were statistically significant differences in our primary endpoint, opioid consumption, on post-operative days 0 (p < 0.001), 1 (p < 0.001), and 2 (p < 0.001). The total opioid requirements over the course of admission were lower in the ERAS group compared to the non-ERAS group (p = 0.03). The initiation of an ERAS protocol employing multimodal analgesia and a QL block, for patients undergoing robotic-assisted laparoscopic partial or radical nephrectomies, can decrease opioid requirements without compromising perioperative outcomes.

Implementation of a multimodal opioid-sparing enhanced recovery pathway for robotic-assisted radical prostatectomy.

The purpose of the study is to evaluate the impact of a multimodal Enhanced Recovery After Surgery (ERAS) protocol on perioperative opioid consumption and hospital length of stay (LOS) after robotic-assisted radical prostatectomy (RARP). We compared the first 176 patients enrolled in the protocol (ERAS group) with the previous 176 patients (non-ERAS group) at a single quaternary institution from December 2017 to June 2019. The ERAS protocol included a multimodal opioid-sparing regimen utilizing acetaminophen, gabapentin, celecoxib, and liposomal bupivacaine. Demographic data, co-morbidities, post-operative pain scores, post-operative opiate consumption measured by morphine milligram equivalents (MME), operating time, and LOS were collected. The two groups were compared using chi-squared, Fisher exact, or Student t tests as appropriate. Multivariable logistic regression analysis was performed to identify predictors of prolonged LOS (> 1 day). The ERAS and non-ERAS groups were equivalent in terms of baseline characteristics and pathological data. The ERAS group had lower post-operative pain scores, post-operative opiate consumption (MME 15 vs. 46, p < 0.01), and LOS (1.2 vs. 1.7 days, p < 0.01) compared to the non-ERAS group. Only 22% in the ERAS cohort had a prolonged LOS compared to 39% of the non-ERAS group (p < 0.01). The ERAS protocol was a negative predictor of prolonged LOS on multivariable logistic regression analysis (odds ratio 0.39, 95% confidence interval 0.22-0.70, p < 0.01). A limitation of this study is its single-center retrospective design. The implementation of a multimodal opioid-sparing ERAS protocol was associated with improved pain control, reduced perioperative opioid usage, and shorter LOS after RARP.