Impact of preexisting opioid dependence on morbidity, length of stay, and inpatient cost of urological oncological surgery.

OBJECTIVES: To determine the incidence of preexisting opioid dependence in patients undergoing elective urological oncological surgery. In addition, to quantify the impact of preexisting opioid dependence on outcomes and cost of common urologic oncological procedures at a national level in the USA. METHODS: We used the National Inpatient Sample (NIS) to study 1,609,948 admissions for elective partial/radical nephrectomy, radical prostatectomy, and cystectomy procedures. Trends of preexisting opioid dependence were studied over 2003-2014. We use multivariable-adjusted analysis to compare opioid-dependent patients to those without opioid dependence (reference group) in terms of outcomes, namely major complications, length of stay (LOS), and total cost. RESULTS: The incidence of opioid dependence steadily increased from 0.6 per 1000 patients in 2003 to 2 per 1000 in 2014. Opioid-dependent patients had a significantly higher rate of major complications (18 vs 10%; p < 0.001) and longer LOS (4 days (IQR 2-7) vs 2 days (IQR 1-4); p < 0.001), when compared to the non-opioid-dependent counterparts. Opioid dependence also increased the overall cost by 48% (adjusted median cost $18,290 [IQR 12,549-27,715] vs. $12,383 [IQR 9225-17,494] in non-opioid-dependent, p < 0.001). Multivariable analysis confirmed the independent association of preexisting opioid dependence with major complications, length of stay in 4th quartile, and total cost in 4th quartile. CONCLUSIONS: The incidence of preexisting opioid dependence before elective urological oncology is increasing and is associated with adverse outcomes after surgery. There is a need to further understand the challenges associated with opioid dependence before surgery and identify and optimize these patients to improve outcomes.

Multidisciplinary teams for the proper management of patients with genitourinary tumors: When topics set scientific societies' agenda.

INTRODUCTION: The multidisciplinary management of oncologic patients is identified as the bottom line element of quality in tumor care. METHODS: In 2015, 7 Italian scientific societies representing the specialists involved in the diagnosis and treatment of genitourinary tumors joined efforts in the Italian uro-oncologic multidisciplinary teams (MDTs) project. The aims were to promote the reorganization of genitourinary cancer care, switching to a multidisciplinary approach, reach a consensus on the core elements for the setup of MDTs in genitourinary oncology, and support health policy makers and managers in remodeling of the assistance and care of uro-oncologic patients on a national level. RESULTS: The first activity was the setup of 5 working groups, given the task of exploring selected topics: general principles, organization of MDTs, minimal requirements, economic evaluation, and relations with authorities. The groups participated in the writing of a document that was approved by the scientific societies and published on their web sites. Moreover, a few items summarizing the extensive document were approved in the first MDT Consensus Conference held in Milan in December 2015. CONCLUSIONS: The experience of this initial phase led to the opening of the team to other professionals and societies, in line with a correct management of patients with genitourinary tumors, which need a multidisciplinary as well as a multiprofessional approach with emerging techniques and procedures, and with a new project work package on genitourinary paths of care and indicators.

Training Modalities in Robot-assisted Urologic Surgery: A Systematic Review.

CONTEXT: Novel surgical techniques demand that surgical training adapts to the need for technical and nontechnical skills. OBJECTIVE: To identify training methods available for robot-assisted surgical (RAS) training in urology, evaluate their effectiveness in terms of validation, educational impact, acceptability, and cost effectiveness, and assess their effect on learning curves (LCs). EVIDENCE ACQUISITION: A systematic review following Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines searched Ovid Medline, Embase, PsycINFO, and the Cochrane Library. Results were screened to include appropriate studies. Quality was evaluated. Each method was evaluated, and conclusions were drawn regarding LCs. EVIDENCE SYNTHESIS: Of 359 records, 24 were included (521 participants). Training methods included dry-lab training (n=7), wet-lab training (n=7), mentored training (n=7), and nonstructured pathways (n=5). Dry-lab training demonstrated educational impact by reducing console time and was acceptable in a study; 100% of participants confirmed face validity. Wet-lab training principally uses human cadaveric material; effectiveness is well rated, although dry-lab training and observation were rated as equally useful. Mentored programmes combine lectures, tutorials, observation, simulation, and proctoring. Minifellowships were linked to greater practice of RAS 1 yr later. LCs vary according to experience. One study found that surgeons from robot-related fellowships demonstrated fewer positive surgical margins than surgeons from laparoscopic-related fellowships (24% vs 34.6%; p=0.05) and reduced time (132 vs 152min; p=0.0003). Five studies examined nonstructured training pathways (clinical practice). Experience correlated with fewer complications (p=0.007), improved continence (p=0.049), and reduced time (p=0.002). CONCLUSIONS: RAS training methods include dry and wet lab, mentored training, and nonstructured pathways. Limited available evidence suggests that they affect LCs differently and are rarely used alone. The different methods of training appear effective when combined. Their benefits must be explored to facilitate validated acceptable training with educational impact. PATIENT SUMMARY: Robot-assisted training encompasses several methods used in combination, but more evidence is required to gain the greatest benefit and formulate future training pathways.

Modular Training for Robot-Assisted Radical Prostatectomy: Where to Begin?

OBJECTIVE: Effective training is paramount for patient safety. Modular training entails advancing through surgical steps of increasing difficulty. This study aimed to construct a modular training pathway for use in robot-assisted radical prostatectomy (RARP). It aims to identify the sequence of procedural steps that are learnt before surgeons are able to perform a full procedure without an intervention from mentor. DESIGN: This is a multi-institutional, prospective, observational, longitudinal study. We used a validated training tool (RARP Score). Data regarding surgeons' stage of training and progress were collected for analysis. A modular training pathway was constructed with consensus on the level of difficulty and evaluation of individual steps. We identified and recorded the sequence of steps performed by fellows during their learning curves. SETTING AND PARTICIPANTS: We included 15 urology fellows from UK, Europe, and Australia. RESULTS: A total of 15 surgeons were assessed by mentors in 425 RARP cases over 8 months (range: 7-79) across 15 international centers. There were substantial differences in the sequence of RARP steps according to the chronology of the procedure, difficulty level, and the order in which surgeons actually learned steps. Steps were not attempted in chronological order. The greater the difficulty, the later the cohort first undertook the step (p = 0.021). The cohort undertook steps of difficulty level I at median case number 1. Steps of difficulty levels II, III, and IV showed more variation in median case number of the first attempt. We recommend that, in the operating theater, steps be learned in order of increasing difficulty. A new modular training route has been designed. This incorporates the steps of RARP with the following order of priority: difficulty level > median case number of first attempt > most frequently undertaken in surgical training. CONCLUSIONS: An evidence-based modular training pathway has been developed that facilitates a safe introduction to RARP for novice surgeons.

Structured and Modular Training Pathway for Robot-assisted Radical Prostatectomy (RARP): Validation of the RARP Assessment Score and Learning Curve Assessment.

BACKGROUND: Use of robot-assisted radical prostatectomy (RARP) for prostate cancer is increasing. Structured surgical training and objective assessment are critical for outcomes. OBJECTIVE: To develop and validate a modular training and assessment pathway via Healthcare Failure Mode and Effect Analysis (HFMEA) for trainees undertaking RARP and evaluate learning curves (LCs) for procedural steps. DESIGN, SETTING, AND PARTICIPANTS: This multi-institutional (Europe, Australia, and United States) observational prospective study used HFMEA to identify the high-risk steps of RARP. A specialist focus group enabled validation. Fifteen trainees who underwent European Association of Urology robotic surgery curriculum training performed RARP and were assessed by mentors using the tool developed. Results produced LCs for each step. A plateau above score 4 indicated competence. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used a modular training and assessment tool (RARP Assessment Score) to evaluate technical skills. LCs were constructed. Multivariable Kruskal-Wallis, Mann-Whitney U, and κ coefficient analyses were used. RESULTS AND LIMITATIONS: Five surgeons were observed for 42 console hours to map steps of RARP. HFMEA identified 84 failure modes and 46 potential causes with a hazard score ≥8. Content validation created the RARP Assessment Score: 17 stages and 41 steps. The RARP Assessment Score was acceptable (56.67%), feasible (96.67%), and had educational impact (100%). Fifteen robotic surgery trainees were assessed for 8 mo. In 426 RARP cases (range: 4-79), all procedural steps were attempted by trainees. Trainees were assessed with the RARP Assessment Score by their expert mentors, and LCs for individual steps were plotted. LCs demonstrated plateaus for anterior bladder neck transection (16 cases), posterior bladder neck transection (18 cases), posterior dissection (9 cases), dissection of prostatic pedicle and seminal vesicles (15 cases), and anastomosis (17 cases). Other steps did not plateau during data collection. CONCLUSIONS: The RARP Assessment Score based on HFMEA methodology identified critical steps for focused RARP training and assessed surgeons. LCs demonstrate the experience necessary to reach a level of competence in technical skills to protect patients. PATIENT SUMMARY: We developed a safety and assessment tool to gauge the technical skills of surgeons performing robot-assisted radical prostatectomy. Improvement was monitored, and measures of progress can be used in future to guide mentors when training surgeons to operate safely.

Cost-utility analysis of radical nephrectomy versus partial nephrectomy in the management of small renal masses: Adjusting for the burden of ensuing chronic kidney disease.

OBJECTIVES: We compare the cost-utility of laparoscopic radical nephrectomy (LRN), laparoscopic partial nephrectomy (LPN) and open partial nephrectomy (OPN) in the management of small renal masses (SRMs) when the impact of ensuing chronic kidney disease (CKD) disease is considered. METHODS: We designed a Markov decision analysis model with a 10-year time horizon. Estimates of costs, utilities, complication rates and probabilities of developing CKD were derived from the literature. The base case patient was assumed to be a 65-year-old patient with a <4-cm unilateral renal mass, a normal contralateral kidney and a normal preoperative serum creatinine. Univariate and probabilistic sensitivity analyses were conducted to address the uncertainty associated with the study parameters. RESULTS: OPN was the least costly strategy at $25 941 USD and generated 7.161 quality-adjusted life years (QALYs) over 10 years. LPN yielded 0.098 additional QALYs at an additional cost of $888 for an incremental cost-effectiveness ratio of $9057 per QALY, well below a commonly cited willingness-to-pay threshold of $50 000 per QALY. LRN was more costly and yielded fewer QALYs than OPN and LPN. Sensitivity analyses demonstrated our model to be robust to changes to key parameters. Age had no effect on preferred strategy. CONCLUSIONS: Partial nephrectomy (PN) is the preferred treatment strategy for SRMs. In centres where LPN is not available, OPN remains considerably more cost-effective than LRN. Furthermore, our study demonstrates that there is no age at which PN is not preferred to LRN. Our study provides additional evidence to advocate PN for the management of all amenable SRMs.

Clinical nodal staging scores for bladder cancer: a proposal for preoperative risk assessment.

BACKGROUND: Radical cystectomy (RC) with pelvic lymph node dissection (LND) is the standard of care for refractory non-muscle-invasive and muscle-invasive bladder cancer. Although consensus exists on the need for LND, its extent is still debated. OBJECTIVE: To develop a model that allows preoperative determination of the minimum number of lymph nodes (LNs) needed to be removed at RC to ensure true nodal status. DESIGN, SETTING, AND PARTICIPANTS: We analyzed data from 4335 patients treated with RC and pelvic LND without neoadjuvant chemotherapy at 12 academic centers located in the United States, Canada, and Europe. MEASUREMENTS: We estimated the sensitivity of pathologic nodal staging using a beta-binomial model and developed clinical (preoperative) nodal staging scores (cNSS), which represent the probability that a patient has LN metastasis as a function of the number of examined nodes. RESULTS AND LIMITATIONS: The probability of missing a positive LN decreased with an increasing number of nodes examined (52% if 3 nodes were examined, 40% if 5 were examined, and 26% if 10 were examined). A cNSS of 90% was achieved by examining 6 nodes for clinical Ta-Tis tumors, 9 nodes for cT1 tumors, and 25 nodes for cT2 tumors. In contrast, examination of 25 nodes provided only 77% cNSS for cT3-T4 tumors. The study is limited due to its retrospective design, its multicenter nature, and a lack of preoperative staging parameters. CONCLUSIONS: Every patient treated with RC for bladder cancer needs an LND to ensure accurate nodal staging. The minimum number of examined LNs for adequate staging depends preoperatively on the clinical T stage. Predictive tools can give a preoperative estimation of the likelihood of nodal metastasis and thereby allow tailored decision-making regarding the extent of LND at RC.

Many facets of chromosome 3p cytogenetic findings in clear cell renal carcinoma: the need for agreement in assessment FISH analysis to avoid diagnostic errors.

Abnormalities of the locus chromosome 3p and the entire chromosome 3 are involved in the cancerogenesis of clear cell renal carcinoma and may be detected by interphase fluorescence in situ hybridization (interphase FISH). We observed a variable detection rate of chromosome 3p/3 abnormalities in different series of clear cell renal carcinoma. Therefore, we focused on problematic issues when performing analysis on routinely available formalin-fixed and paraffin embedded tissue. A group of studies encountered a single approach to chromosome 3p detection, by using probe/s to map different codes of the short arm 3p without a control of the entire chromosome 3. Deletion of chromosome 3p and monosomy of chromosome 3 ranged from 38% to 100% in clear cell renal carcinoma. Cut-off values for the threshold were chosen randomly or obtained by calculation of the mean value plus 1 or 2 or 3 standard deviations. Loss of chromosome 3p was assessed either as the percentage of single signals on the total number of nuclei, or applying a double approach with corrections of control chromosome 3. Moreover, cut off values were sometimes arbitrarily corrected with the findings from normal adjacent renal parenchyma. A consensus of experts in the field is needed in order to define the best methodological approach and the appropriate threshold in assessment 3p deletion when interphase FISH is performed in clear cell renal carcinoma. This harbours relevant diagnostic and therapeutic implications, at light also of targeted therapies recently available to clear cell renal carcinoma.

Downsides of robot-assisted laparoscopic radical prostatectomy: limitations and complications.

CONTEXT: Robot-assisted laparoscopic radical prostatectomy (RALP) using the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) is now in widespread use for the management of localised prostate cancer (PCa). Many reports of the safety and efficacy of this procedure have been published. However, there are few specific reports of the limitations and complications of RALP. OBJECTIVE: The primary purpose of this review is to ascertain the downsides of RALP by focusing on complications and limitations of this approach. EVIDENCE ACQUISITION: A Medline search of the English-language literature was performed to identify all papers published since 2001 relating to RALP. Papers providing data on technical failures, complications, learning curve, or other downsides of RALP were considered. Of 412 papers identified, 68 were selected for review based on their relevance to the objective of this paper. EVIDENCE SYNTHESIS: RALP has the following principal downsides: (1) device failure occurs in 0.2-0.4% of cases; (2) assessment of functional outcome is unsatisfactory because of nonstandardised assessment techniques; (3) overall complication rates of RALP are low, although higher rates are noted when complications are reported using a standardised system; (4) long-term oncologic data and data on high-risk PCa are limited; (5) a steep learning curve exists, and although acceptable operative times can be achieved in <20 cases, positive surgical margin (PSM) rates may require experience with >80 cases before a plateau is achieved; (6) robotic assistance does not reduce the difficulty associated with obese patients and those with large prostates, middle lobes, or previous surgery, in whom outcomes are less satisfactory than in patients without such factors; (7) economic barriers prevent uniform dissemination of robotic technology. CONCLUSIONS: Many of the downsides of RALP identified in this paper can be addressed with longer-term data and more widespread adoption of standardised reporting measures. The significant learning curve should not be understated, and the expense of this technology continues to restrict access for many patients.

Pain assessment after original transperineal prostate biopsy using a coaxial needle.

OBJECTIVES: To assess whether the use of a coaxial needle reduces discomfort in patients undergoing multiple-core transperineal prostate biopsy to detect prostate cancer. METHODS: From October 2002 to January 2003, we enrolled 102 consecutive patients with a suspicion of prostate cancer. In every case, we performed a 14-core transperineal prostate biopsy under transrectal ultrasound guidance. The patients were randomized into two groups: group 1 (n = 51) in which we used the 17-gauge coaxial TruGuide needle, and group 2 (n = 51) in which the conventional transperineal technique was used. At the end of the procedure, patients were asked to complete a questionnaire regarding the level of pain experienced. RESULTS: The studied groups were comparable in age, total prostate-specific antigen value, and prostate volume. The whole procedure was significantly less painful in group 1 (2.20 +/- 1.20 versus 2.90 +/- 1.73, P = 0.01). We failed to show any significant pain score differences during rectal probe insertion (P = 0.10), transrectal ultrasonography (P = 0.16), and execution of local anesthesia (P = 0.11). The pain score recorded during the multiple-core prostate sampling was significantly lower in group 1 (1.53 +/- 1.5 versus 2.43 +/- 1.86, P = 0.009). No statistically significant differences were found in the complication rates between the two groups. CONCLUSIONS: The use of a coaxial needle reduces the procedure's invasiveness and patient's pain compared with the conventional transperineal prostate biopsy.