Abstract
We would like to thank the Journal of Endourology for its positive feedback on our recent publication. 1 As is correctly pointed out, we aimed to explore the efficacy and safety of fluoroless ureteroscopy (fURS) compared with conventional ureteroscopy (cURS) in the management of ureteral and renal stones.
In our meta-analysis, stone-free rate (SFR) was the primary endpoint as a surrogate for efficacy. As extensively presented and discussed in our study, the data suggest that fURS has an SFR similar to that achieved with cURS, without any increase in complication rate, operating time, hospital stay, or secondary procedures and with a low conversion rate to cURS. These data suggest that fURS is as effective as cURS in the management of ureteral and renal stones.
However, it is clear that these results should be interpreted with caution given that the ‘‘stone-free status’’ was assessed differently across the studies; most studies reported use of a combination of X-ray and ultrasound in postoperative assessment, whereas others reported the systematic use of CT scan. The postoperative follow-up ranged from postoperative day 1 to the third month, and the definition of “stone free” varied from the absence of any fragments to the presence of fragments up to 4 mm. In our opinion, to assess the absolute efficacy of fURS and to achieve homogeneity in reporting of the SFR between reports, it would be appropriate to determine the SFR by means of a low-dose CT scan at a regular interval of time (3 months) and to standardize the definition of stone free as the absence of any fragments.
We also found heterogeneity across the studies regarding definition of fURS, surgical technique, preoperative assessment, and postoperative follow-up. The interpretation of complications was another challenging issue, because stratification according to the Clavien–Dindo classification was not used in all studies. Furthermore, the definition of each complication was not established in the studies, and the complications that occurred at each grade in the Clavien–Dindo classification were not described in all reports; therefore, the data were not available for extraction in all studies.
Although our study is subject to these limitations, to our knowledge it represents the first systematic review and meta-analysis on the efficacy and safety of fURS. Moreover, the analysis attempts to fill a gap in the current literature while emphasizing the need to conduct well-designed clinical trials with the intention of minimizing the dogmatic use of fluoroscopy in endourologic procedures.
We also want to comment on other concerns that emerge from the editorial comment: The finding that fURS can be safely and effectively employed in the hands of a skilled endourologist is not in itself a finding capable of changing many minds. Therefore, it was not the objective of this study to address this issue. In our opinion, considering the risk from radiation exposure for both patients and physicians, our study provides sufficient justification to standardize the practice and teaching of fURS in all urology departments, in accordance with the As Low As Reasonably Achievable (ALARA) principle. Urologists must understand that ALARA is not an “all-or-nothing” principle. We think that there is no single approach to comply with the ALARA principle. For example, several urologic centers have instituted reduced fluoroscopy protocols or low-radiation protocols consisting of well-established steps (check-list) to decrease the fluoroscopy time during endoscopic procedures.
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Moreover, it must be assumed that the ALARA principle does not begin or end in the operating room; rather, it encompasses the entire diagnostic, therapeutic, and follow-up process. Therefore, strategies to reduce exposure to X-rays must be implemented in each phase of medical care. The main goal of URS/RIRS (retrograde intrarenal surgery) is to achieve a real stone-free status without complications or potential complications. The procedure must also be safe for both the patient and the surgeon. In this context, we consider that the indiscriminate use of fluoroscopy during URS/RIRS could be critically reduced and that steps must be taken to improve the technique to achieve a stone-free status without complications and with the least cumulative radiation.
The data from our meta-analysis should not be taken to support the assumption that fluoroscopy is unnecessary during URS/RIRS. Therefore, in the operating room, the endourologist should always be prepared for conversion to cURS when necessary. However, in our opinion, all URSs should be performed in accordance with the ALARA principle.