Hospital volume-outcome relationships for robot-assisted surgeries: a population-based analysis.

BACKGROUND: Associations between procedure volumes and outcomes can inform minimum volume standards and the regionalization of health services. Robot-assisted surgery continues to expand globally; however, data are limited regarding which hospitals should be using the technology. STUDY DESIGN: Using administrative health data for all residents of Ontario, Canada, this retrospective cohort study included adult patients who underwent a robot-assisted radical prostatectomy (RARP), total robotic hysterectomy (TRH), robot-assisted partial nephrectomy (RAPN), or robotic portal lobectomy using 4 arms (RPL-4) between January 2010 and September 2021. Associations between yearly hospital volumes and 90-day major complications were evaluated using multivariable logistic regression models adjusted for patient characteristics and clustering at the level of the hospital. RESULTS: A total of 10,879 patients were included, with 7567, 1776, 724, and 812 undergoing a RARP, TRH, RAPN, and RPL-4, respectively. Yearly hospital volume was not associated with 90-day complications for any procedure. Doubling of yearly volume was associated with a 17-min decrease in operative time for RARP (95% confidence interval [CI] - 23 to - 10), 8-min decrease for RAPN (95% CI - 14 to - 2), 24-min decrease for RPL-4 (95% CI - 29 to - 19), and no significant change for TRH (- 7 min; 95% CI - 17 to 3). CONCLUSION: The risk of 90-day major complications does not appear to be higher in low volume hospitals; however, they may not be as efficient with operating room utilization. Careful case selection may have contributed to the lack of an observed association between volumes and complications.

Hospital learning curves for robot-assisted surgeries: a population-based analysis.

BACKGROUND: Robot-assisted surgery has been rapidly adopted. It is important to define the learning curve to inform credentialling requirements, training programs, identify fast and slow learners, and protect patients. This study aimed to characterize the hospital learning curve for common robot-assisted procedures. STUDY DESIGN: This cohort study, using administrative health data for Ontario, Canada, included adult patients who underwent a robot-assisted radical prostatectomy (RARP), total robotic hysterectomy (TRH), robot-assisted partial nephrectomy (RAPN), or robotic portal lobectomy using four arms (RPL-4) between 2010 and 2021. The association between cumulative hospital volume of a robot-assisted procedure and major complications was evaluated using multivariable logistic models adjusted for patient characteristics and clustering at the hospital level. RESULTS: A total of 6814 patients were included, with 5230, 543, 465, and 576 patients in the RARP, TRH, RAPN, and RPL-4 cohorts, respectively. There was no association between cumulative hospital volume and major complications. Visual inspection of learning curves demonstrated a transient worsening of outcomes followed by subsequent improvements with experience. Operative time decreased for all procedures with increasing volume and reached plateaus after approximately 300 RARPs, 75 TRHs, and 150 RPL-4s. The odds of a prolonged length of stay decreased with increasing volume for patients undergoing a RARP (OR 0.87; 95% CI 0.82-0.92) or RPL-4 (OR 0.77; 95% CI 0.68-0.87). CONCLUSION: Hospitals may adopt robot-assisted surgery without significantly increasing the risk of major complications for patients early in the learning curve and with an expectation of increasing efficiency.

The evolving use of robotic surgery: a population-based analysis.

INTRODUCTION: Robotic surgery has integrated into the healthcare system despite limited evidence demonstrating its clinical benefit. Our objectives were (i) to describe secular trends and (ii) patient- and system-level determinants of the receipt of robotic as compared to open or laparoscopic surgery. METHODS: This population-based retrospective cohort study included adult patients who, between 2009 and 2018 in Ontario, Canada, underwent one of four commonly performed robotic procedures: radical prostatectomy, total hysterectomy, thoracic lobectomy, partial nephrectomy. Patients were categorized based on the surgical approach as robotic, open, or laparoscopic for each procedure. Multivariable regression models were used to estimate the temporal trend in robotic surgery use and associations of patient and system characteristics with the surgical approach. RESULTS: The cohort included 24,741 radical prostatectomy, 75,473 total hysterectomy, 18,252 thoracic lobectomy, and 4608 partial nephrectomy patients, of which 6.21% were robotic. After adjusting for patient and system characteristics, the rate of robotic surgery increased by 24% annually (RR 1.24, 95%CI 1.13-1.35): 13% (RR 1.13, 95%CI 1.11-1.16) for robotic radical prostatectomy, 9% (RR 1.09, 95%CI 1.05-1.13) for robotic total hysterectomy, 26% (RR 1.26, 95%CI 1.06-1.50) for thoracic lobectomy and 26% (RR 1.26, 95%CI 1.13-1.40) for partial nephrectomy. Lower comorbidity burden, earlier disease stage (among cancer cases), and early career surgeons with high case volume at a teaching hospital were consistently associated with the receipt of robotic surgery. CONCLUSION: The use of robotic surgery has increased. The study of the real-world clinical outcomes and associated costs is needed before further expanding use among additional providers and hospitals.

Adverse events following robotic surgery: population-based analysis.

BACKGROUND: Robotic surgery was integrated into some healthcare systems despite there being few well designed, real-world studies on safety or benefit. This study compared the safety of robotic with laparoscopic, thoracoscopic, and open approaches in common robotic procedures. METHODS: This was a population-based, retrospective study of all adults who underwent prostatectomy, hysterectomy, pulmonary lobectomy, or partial nephrectomy in Ontario, Canada, between 2008 and 2018. The primary outcome was 90-day total adverse events using propensity score overlap weights, and secondary outcomes were minor or major morbidity/adverse events. RESULTS: Data on 24 741 prostatectomy, 75 473 hysterectomy, 18 252 pulmonary lobectomy, and 6608 partial nephrectomy operations were included. Relative risks for total adverse events in robotic compared with open surgery were 0.80 (95 per cent c.i. 0.74 to 0.87) for radical prostatectomy, 0.44 (0.37 to 0.52) for hysterectomy, 0.53 (0.44 to 0.65) for pulmonary lobectomy, and 0.72 (0.54 to 0.97) for partial nephrectomy. Relative risks for total adverse events in robotic surgery compared with a laparoscopic/thoracoscopic approach were 0.94 (0.77 to 1.15), 1.00 (0.82 to 1.23), 1.01 (0.84 to 1.21), and 1.23 (0.82 to 1.84) respectively. CONCLUSION: The robotic approach is associated with fewer adverse events than an open approach but similar to a laparoscopic/thoracoscopic approach. The benefit of the robotic approach is related to the minimally-invasive approach rather than the platform itself.

Simple prostatectomy using the open and robotic approaches for lower urinary tract symptoms: A retrospective, case-control series.

INTRODUCTION: We aimed to assess the outcome of our series of simple prostatectomy at our institution using the open simple prostatectomy (OSP) and robotic-assisted simple prostatectomy (RASP) approaches. METHODS: We conducted a retrospective chart review of men who underwent OSP and RASP at Western University, in London, ON. Preoperative, intraoperative, and postoperative data were collected and analyzed. RESULTS: From 2012-2020, 29 men underwent a simple prostatectomy at our institution. Eight patients underwent an OSP and 21 patients underwent a RASP. The median age was 69 years. Preoperative median prostate volume was 153 cm³ (range 80-432). The surgical indications were failed medical treatment, urinary retention, hydronephrosis, cystolithiasis, and recurrent hematuria. The median operative time was 137.5 minutes in OSP and 185 minutes in RASP (p=0.04). Median estimated blood loss was 2300 ml (range 600-4000) and 100 ml (range 50-400) in the open and robotic procedures, respectively (p=0.4). The mean length of hospital stay was shorter in the RASP group, one day vs. three days (z=4.152, p<0.005). Perioperative complication rates were significantly lower in the group undergoing RASP, with no complications recorded in this group (p=0.004). Both groups demonstrated excellent functional results, with most patients reporting complete urinary continence (p=0.8). CONCLUSIONS: We report very good perioperative outcomes, with a minimal risk profile and excellent functional results, leading to marked improvement in patients' symptoms at followup after both the OSP and RASP approaches. RASP was associated with a shorter length of hospital stay, decreased blood loss, and a lower complication rate.

Potential Pitfalls in Pre-implantation Genetic Diagnosis in a Patient with Tuberous Sclerosis and Isolated Mosaicism for a TSC2 Variant in Renal Tissue.

Tuberous sclerosis complex (TSC) is an autosomal dominant disorder that displays a wide spectrum of clinical manifestations, often affecting multiple organs including the kidneys, brain, lungs, and skin. A pathogenic mutation in either the TSC1 or TSC2 gene can be detected in almost 85% of the cases, with mosaicism accounting for about half of the remaining cases. We report a case of TSC diagnosed clinically, requesting genetic counselling regarding reproductive risks. No mutation was identified on initial testing of peripheral blood; however, mosaicism for a likely pathogenic frameshift variant in TSC2 was detected at a level of 15% in renal angiomyolipoma tissue. Despite widespread clinical manifestations of TCS, this variant was not detected in skin fibroblasts or saliva, raising the possibility this is an isolated somatic mutation in renal tissue with the underlying germline mutation not yet identified. This case highlights the difficulties when counselling patients with mosaicism regarding their reproductive risks and prenatal diagnostic options.

Ureteral Stent Microbiota Is Associated with Patient Comorbidities but Not Antibiotic Exposure.

Ureteral stents are commonly used to prevent urinary obstruction but can become colonized by bacteria and encrusted, leading to clinical complications. Despite recent discovery and characterization of the healthy urinary microbiota, stent-associated bacteria and their impact on encrustation are largely underexplored. We profile the microbiota of patients with typical short-term stents, as well as over 30 atypical cases (all with paired mid-stream urine) from 241 patients. Indwelling time, age, and various patient comorbidities correlate with alterations to the stent microbiota composition, whereas antibiotic exposure, urinary tract infection (UTI), and stent placement method do not. The stent microbiota most likely originates from adhesion of resident urinary microbes but subsequently diverges to a distinct, reproducible population, thereby negating the urine as a biomarker for stent encrustation or microbiota. Urological practice should reconsider standalone prophylactic antibiotics in favor of tailored therapies based on patient comorbidities in efforts to minimize bacterial burden, encrustation, and complications of ureteral stents.

Small Renal Mass Surveillance: Histology-specific Growth Rates in a Biopsy-characterized Cohort.

BACKGROUND: Most reports of active surveillance (AS) of small renal masses (SRMs) lack biopsy confirmation, and therefore include benign tumors and different subtypes of renal cell carcinoma (RCC). OBJECTIVE: We compared the growth rates and progression of different histologic subtypes of RCC SRMs (SRMRCC) in the largest cohort of patients with biopsy-characterized SRMs on AS. DESIGN, SETTING, AND PARTICIPANTS: Data from patients in a multicenter Canadian trial and a Princess Margaret cohort were combined to include 136 biopsy-proven SRMRCC lesions managed by AS, with treatment deferred until progression or patient/surgeon decision. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Growth curves were estimated from serial tumor size measures. Tumor progression was defined by sustained size ≥4 cm or volume doubling within 1 yr. RESULTS AND LIMITATIONS: Median follow-up for patients who remained on AS was 5.8 yr (interquartile range 3.4-7.5 yr). Clear cell RCC SRMs (SRMccRCC) grew faster than papillary type 1 SRMs (0.25 and 0.02 cm/yr on average, respectively, p = 0.0003). Overall, 60 SRMRCC lesions progressed: 49 (82%) by rapid growth (volume doubling), seven (12%) increasing to ≥4 cm, and four (6.7%) by both criteria. Six patients developed metastases, and all were of clear cell RCC histology. Limitations include the use of different imaging modalities and a lack of central imaging review. CONCLUSIONS: Tumor growth varies between histologic subtypes of SRMRCC and among SRMccRCC, which likely reflects individual host and tumor biology. Without validated biomarkers that predict this variation, initial follow-up of histologically characterized SRMs can inform personalized treatment for patients on AS. PATIENT SUMMARY: Many small kidney cancers are suitable for surveillance and can be monitored over time for change. We demonstrate that different types of kidney cancers grow at different rates and are at different risks of progression. These results may guide better personalized treatment.

Case report - Primary renal echinococcal infection.

Renal echinococcal infection is an uncommonly encountered infection in North America but is endemic in many parts of the world. With increasing migration, it is conceivable that practicing Canadian physicians will see more patients presenting at various stages of infection. Herein, we describe an unusual presentation of primary renal echinococcal infection and describe current diagnostic, as well as medical and surgical management strategies.

Hydro-Jet Dissection of the Cavernous Nerves Preserves Erection Function in a Radical Prostatectomy Animal Model.

BACKGROUND: Postoperative erectile dysfunction (ED) remains a prevalent consequence of radical prostatectomy (RP) that significantly impacts patient quality of life. Water-jet technology is widely used for dissection in neurosurgical procedures but novel to urologic surgery. AIM: To establish the impact of hydro-jet dissection (HJD) of the cavernous nerves (CN) on postoperative erectile function in an animal model of RP-induced ED. METHODS: 32 male Sprague-Dawley rats were randomized to 4 groups: Sham surgery (n = 8), bilateral HJD of CN (n = 8), blunt CN injury (n = 8), or stretch CN injury (n = 8). After 4 weeks, erectile function was assessed by measuring intracavernous pressure (ICP), and penile tissues were harvested for immunohistologic studies. MAIN OUTCOME MEASURE: The peak ICP and the area under the curve were calculated for each group. Immunohistologic studies were performed for α-smooth muscle actin and neuronal nitric oxide synthase on cross-sections of penile tissue. RESULTS: Rats in the HJD group demonstrate a significantly higher mean peak ICP and area under the curve compared with both CN injury groups (P = .001). Postoperative erectile function in the HJD group returned to baseline function. Preservation of α-smooth muscle actin and neuronal nitric oxide synthase was observed in the HJD group compared with the other surgical trauma groups. CLINICAL IMPLICATIONS: Hydro-jet dissection used in an RP animal model maintains erectile function and offers a potential benefit that warrants further human studies. STRENGTHS & LIMITATIONS: This is a novel animal study comparing a new technology to established CN dissection techniques. This study uses an animal model, which may not completely translate to post-RP ED in humans. CONCLUSION: Hydro-jet dissection of the CN during RP in an animal model is associated with significantly better postoperative erectile function when compared with other CN injury. Clinical studies are needed to further investigate the putative benefit of HJD on erectile function in patients undergoing RP. Campbell JD, Alenezi H, DeYoung LX, et al. Hydrojet Dissection of the Cavernous Nerves Preserves Erection Function in a Radical Prostatectomy Animal Model. Sex Med 2019;7:104-110.

Use of cumulative summation (CUSUM) as a tool for early feedback and monitoring in robot-assisted radical prostatectomy outcomes and performance.

INTRODUCTION: Today's surgical practice has evolved, with increasing emphasis on quality assurance. Many forms of quality-control monitoring have been suggested, but they are often impractical or difficult to implement. Cumulative summation (CUSUM) is a simple method to provide visual feedback before significant quality issues arise. We present our initial use and practical application of CUSUM in a surgical practice. METHODS: A retrospective analysis was applied to a prospectively collected database of 577 sequential patients who have undergone robot-assisted radical prostatectomy from a single surgeon over a 10-year period. Outcome measures were analyzed with CUSUM, which included a composite complication score, continence rates, length of hospital stay, biochemical recurrence, and need for adjuvant radiation. If any outcomes were out of control, they would cross the CUSUM failure line. RESULTS: CUSUM chart-plotting for incontinence demonstrated an initial upward slope followed by trending to a new safety limit. Additionally, outcomes in complications and biochemical recurrence did not reach the established safety boundaries. Length of stay and radiation outcomes did initially cross the safety line, but were improved over time. CONCLUSIONS: The use of CUSUM in clinical practice can fulfill the need for quality assurance. CUSUM plotting in our practice reflected the initial learning curve, followed by ongoing maintenance and improvement in performance. These changes were consistent with the implementation of changes in surgical techniques. Although this tool was used retrospectively, this strengthens our argument to implement the tool prospectively and assess real-time refinement of surgeon skill. We have demonstrated that CUSUM can be appropriately used to assure quality control in a surgical practice.

Characterization of clinical human prostate cancer lesions using 3.0-T sodium MRI registered to Gleason-graded whole-mount histopathology.

BACKGROUND: Overtreatment of prostate cancer (PCa) is a healthcare issue. Development of noninvasive imaging tools for improved characterization of prostate lesions might reduce overtreatment. PURPOSE: To measure the distribution of tissue sodium concentration (TSC), proton T2 -weighted signal, and apparent diffusion coefficient (ADC) values in human PCa and to test the presence of a correlation between regional differences in imaging metrics and the Gleason grade of lesions determined from histopathology. STUDY TYPE: Cross-sectional. SUBJECTS: Ten men with biopsy-proven PCa. SEQUENCES/FIELD STRENGTH: Sodium, proton T2 -weighted, and diffusion-weighted MRI data were acquired using Broad-Band 3D-Fast-Gradient-Recalled, 3D Cube (Isotropic 3D-Fast-Turbo-Spin-Echo acquisition) and 2D Spin-Echo sequences, respectively, with a 3.0T MR scanner. ASSESSMENT: All imaging data were coregistered to Gleason-graded postprostatectomy histology, as the standard for prostate cancer lesion characterization. Regional TSC and T2 data were assessed using percent changes from healthy tissue of the same patient (denoted ΔTSC, ΔT2 ). STATISTICS: Differences in ΔTSC, ADC, and ΔT2 as a function of Gleason score were analyzed for each imaging contrast using a one-way analysis of variance or a nonparametric t-test. Correlations between imaging data measures and Gleason score were assessed using a Spearman's ranked correlation. RESULTS: Evaluation of the correlation of ΔTSC, ADC, and ΔT2 datasets with Gleason scoring revealed that only the correlation between ΔTSC and Gleason score was statistically significant (rs = 0.791, p < 0.01), whereas the correlations of ADC and ΔT2 with Gleason score were not (rs = -0.306, p = 0.079 and r s = -0.069, p = 0.699, respectively). In addition, all individual patients showed monotonically increasing ΔTSC with Gleason score. DATA CONCLUSION: The results of this preliminary study suggest that changes in TSC, assessed by sodium MRI, has utility as a noninvasive imaging assay to accurately characterize PCa lesions. Sodium MRI may provide useful complementary information on mpMRI, which may assist the decision-making of men choosing either active surveillance or treatment. LEVEL OF EVIDENCE: 1 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2019;49:1409-1419.

A Population-Based Cohort Study of the Impact of Infectious Complications Requiring Hospitalization after Prostate Biopsy on Radical Prostatectomy Surgical Outcomes.

OBJECTIVE: To compare radical prostatectomy outcomes in men with and without exposure to a major infectious event within 30-days of a prior TRUS-biopsy. MATERIALS AND METHODS: This retrospective cohort study included men who underwent radical prostatectomy from 2002 to 2013 in Ontario, Canada. Several linked administrative databases were used. Exposure was defined as hospitalization with evidence of a urinary tract infection or sepsis during the first 30-days after a prostate biopsy. The primary outcome was a composite of procedures indicative of a likely serious complication of radical prostectomy within the first 12 months after surgery. Secondary outcomes included oncological, functional, and hospital related events within 2 years of radical prostatectomy. RESULTS: A total of 26,254 patients were included in this study and 530 (2.02%) had a post-TRUS-biopsy infection. A similar proportion of patients with and without a post-TRUS-biopsy infectious event experienced the composite primary outcome (1.7% vs 1.1%; odds ratio [OR] 1.61, 95% confidence interval [CI] 0.82-3.14; P = .16). However, exposed patients had significantly higher odds of perioperative blood transfusion (OR 1.61, 95% CI 1.30-2.00; P <.001), bladder neck contracture (OR 1.35, 95% CI 1.12-1.63; P = .002), and 30-day hospital readmission (OR 2.08, 95% CI 1.47-2.95; P <.001), and a small but significant increase in length of hospital stay (P = 0.005). No other significant differences were observed. CONCLUSION: Although prior infectious events are associated with increased risk of blood transfusion, bladder neck contracture, and hospital readmission following radical prostatectomy, results from this study suggest that major surgical complications, are not adversely affected by TRUS-biopsy related infections.

A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma.

BACKGROUND: Cytoreductive nephrectomy is thought to improve survival in metastatic renal cell carcinoma (mRCC). As many patients are ineligible for major surgery, we hypothesized that SABR could be a safe alternative. METHODS: In this dose-escalation trial, inoperable mRCC patients underwent SABR targeting the entire affected kidney. Toxicity (CTCAE v3.0), quality of life (QoL), renal function, and tumour response (RECIST v1.0) were assessed. RESULTS: Twelve patients of mostly intermediate (67%) or poor (25%) International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic class, median KPS of 70%, and median tumour size of 8.7 cm (range: 4.8-13.8) were enrolled in successive dose cohorts of 25 (n = 3), 30 (n = 6), and 35 Gy (n = 3) in 5 fractions. SABR was well tolerated with 3 grade 3 events: fatigue (2) and bone pain (1). QoL decreased for physical well-being (p = 0.016), but remained unchanged in other domains. SABR achieved a median tumour size reduction of - 17.3% (range: + 5.3 to - 54.4) at 5.3 months. All patients progressed systemically and median OS was 6.7 months. Crude median follow-up was 5.8 months. CONCLUSIONS: In non-operable mRCC patients, renal-ablative SABR to 35 Gy in 5 fractions yielded acceptable toxicity, renal function preservation, and stable QoL. SABR merits further prospective investigation as an alternative to cytoreductive nephrectomy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02264548. Registered July 22 2014 - Retrospectively registered: https://clinicaltrials.gov/ct2/show/NCT02264548.

The impact of patient-, disease-, and treatment-related factors on survival in patients with adrenocortical carcinoma.

INTRODUCTION: Adrenal cortical carcinoma (ACC) is a rare and aggressive endocrine tumour. Most present with advanced disease and have poor prognosis. Optimal treatment includes complete surgical resection. There is limited evidence for the efficacy of chemotherapy and radiation at different stages in this disease. There remain many inconsistencies with respect to diagnosis and workup. There is a lack of uniform guideline recommendations and consensus data. METHODS: We performed a retrospective chart review of all patients at London Health Sciences Centre between 1990 and 2015 using ICD coding. All paper and electronic charts were reviewed and data was collected. Statistical analysis and survival curves were performed. RESULTS: A total of 29 patients were included in our study. Median age was 55 years (interquartile range [IQR] 45-63); 14 (48%) were male and 15 (52%) were female. Approximately half (14 or 48%) of our patients presented symptomatically. Almost half (41%) of tumours were metabolically active, producing hormones. Most (88%) underwent surgical intervention. Surgical margin status was available in about half of patients and lymphadenectomy was performed in a third (n=8) of open adrenalectomy patients. A third received mitotane treatment (8 [73%] adjuvant and 3 [27%] palliative) and a third of patients received radiation. Two- and five-year median overall survival was 53% and 27%, respectively. CONCLUSIONS: ACC is a rare and aggressive tumour. This is the largest Canadian series reported to the best of our knowledge. Limited data for guidelines exists and treatment and workup patterns are inconsistent. Collaborative randomized and prospective studies on a global basis are needed.