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Laparoscopic radical nephrectomy (LRN) is regarded by many as the ‘gold standard’ for the surgical treatment of RCC requiring complete kidney removal . Compared with open radical nephrectomy (ORN), LRN provides equivalent long-term cancer control with shorter hospital stays, less postoperative pain, and faster resumption of normal activities [2–6].
Despite these advantages, LRN for renal cancer has diffused slowly into clinical practice in the USA and remains substantially underused [7,8]. Compared with other laparoscopic surgeries (including donor nephrectomy, cholecystectomy and fundoplication), adoption of LRN into clinical practice has been modest, and ORN remains the predominant surgical approach for kidney cancer . Potential barriers to LRN diffusion include perceived technical complexity, a limited pool of urologists trained in laparoscopy, costs associated with adoption of new technology and techniques, and individual surgeon practice style [9,10].
Another consideration possibly affecting the use of LRN is patient safety. Adoption of surgical innovations depends in large part upon provider acceptance of the new technology, and surgeon perception that ORN is safer than LRN may be a factor contributing to LRN's relatively sluggish diffusion [11,12]. The AUA's clinical guidelines for the management of stage T1 renal masses concluded from a systematic review that LRN was associated with a higher major urological complication rate than ORN ; however, other data suggest comparable, if not superior, peri-operative outcomes for LRN [14,15].
Comprehensive patient safety analyses comparing LRN with ORN, using process-driven measures, have yet to be performed. Safety analyses performed in a wider population of patients and incorporating a comprehensive array of validated patient safety outcomes would potentially inform the selection of operative approaches for nephrectomy, the process by which LRN has entered surgical practice, and the variables affecting the diffusion of innovative surgical techniques. The aim of the present study was to compare the prevalence of adverse patient safety events occurring in ORN and LRN in a national database over a 10-year period.
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To our knowledge, this is the first study to investigate peri-operative outcomes of radical nephrectomy – or any urological surgery – using validated patient safety measures. While systematic analyses of patient safety and quality of care issues have gained broad acceptance within the fields of medicine and health policy [22,23], they have not disseminated as widely among the surgical disciplines . In this population-based analysis, we observed a 32% (ORadj 0.68) decreased probability of patient safety events occurring in LRN compared with ORN as measured by PSIs. Our results thus suggest that use of LRN results in substantially enhanced peri-operative patient safety.
A novel component of the present study is the stratification of the patient safety analyses by year in a period during which LRN was initially diffusing into broader clinical practice. The lower likelihood of adverse safety events with LRN emerged only after the national prevalence of LRN exceeded 10%, a proportion some have proposed as the ‘tipping point’ for the adoption of surgical innovations [12,25]. This phase of diffusion is a point during which early adopters (usually composed of expert opinion leaders) transition into the early majority (those who adopt a new technique just before the average surgeon) . Based on the present data, it is possible that the potential safety benefits of LRN were attained only after completion of a learning curve by the innovators and early adopters, an observation that could have implications for a broader understanding of patient safety as it relates to the diffusion of new surgical techniques.
The present study is also novel in that it is one of the first analyses of nephrectomy for renal tumours to use a large administrative dataset coupled with validated, process-focused, provider-side measures of patient safety. In previous studies in other settings, PSIs have proven to be robust metrics for quality improvement and are valuable in assessing safety because they correlate with adverse events while minimizing potential biases associated with variations in individual patients and care-givers [27–29]. Our results are consistent with those of Tan et al. , who observed among a national cohort of older US patients that LRN was associated with decreased probabilities of prolonged hospitalization, intensive care unit admission, and peri-operative transfusion compared with ORN; however, unlike Tan et al., we did not discern a higher mortality for LRN in the present cohort. Potential explanations include differences in our analytical cohort, which was younger and larger, and the fact that we assessed in-hospital, rather than 30-day, mortality.
Although we did not adjust for tumour size in the analytical models, there are several reasons why it is unlikely that differential bias in tumour size between groups accounted for the observed differences in PSIs. First, we excluded patients that underwent concomitant surgical procedures (thrombectomy and/or vascular reconstruction; pancreatic, splenic or hepatic procedures; bowel resection) indicative of large, complex renal tumours requiring extensive resection and potentially associated with poorer peri-operative outcomes related to aggressive disease. Second, during the study period, ORN remained the dominant operative approach to kidney cancer despite a period of significant stage migration towards smaller and lower stage tumours . An analysis of SEER-Medicare data from 2000 to 2007 noted that ORN continued to account for nearly 70% of renal cancer surgery in these patients at a time when localized or locoregional disease accounted for nearly 80% of cases . Similarly, in a recent case-control analysis conducted by the National Cancer Institute, 79% of renal tumours were ≤7 cm and 52% ≤4 cm; most of these cases were treated with ORN . In the present study, nearly 90% of all surgeries were ORNs, meaning that the vast majority of ORNs were performed for smaller tumours.
Furthermore, while many previous analyses of peri-operative outcomes for renal surgery have included variables for tumour stage and size, the question of whether these variables should be considered in all analytical comparisons of LRN and ORN has never been satisfactorily addressed. For the largest tumours, including those with venous thrombi, there is the potential for significant collinearity between variables for size and surgery type, which in turn can potentially introduce unpredictable biases into analyses comparing laparoscopic with open surgery. Within this context, it is worthwhile noting that, in the analysis by Tan et al. , exclusion of patients with larger renal tumours yielded results similar to those of the overall study.
Nevertheless, lack of patient-specific oncological data, including tumour size or tumour stage, is a potential limitation of the present study and possibly contributed to the observed PSI difference in hospital type, particularly since teaching hospitals would be expected to care for a greater proportion of complex tumours (Table 3). A second limitation is that variations in coding practices over the 10-year study period may have influenced the analyses. These changes included the addition, in more recent years, of laparoscopic-specific procedure codes, and may have been differential with respect to teaching and non-teaching hospitals – increased reporting of PSIs at teaching hospitals, for example, may have contributed to the observed 10% increased prevalence at teaching compared with non-teaching hospitals. Still, there is no evidence to suggest that such variations would have been differential with respect to the primary study outcomes. Finally, we could only assess adverse outcomes that occurred during the period of hospitalization after surgery. It is possible that differential outcomes of adverse events occurring after discharge, but still within the peri-operative period (i.e. 30 days), were not captured.
In conclusion, LRN was associated with substantially superior peri-operative patient safety outcomes than ORN, but only after the prevalence of LRN exceeded 10% of cases nationally. Further study is needed to explain these patterns and promote the safe diffusion of novel surgical therapies into broad practice.