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Editorial: Renal access during PCNL: increasing value of USG for a safer and successful procedure

Renal access to the pelvicalyceal system is the initial but highly important and crucial step of percutaneous nephrolithotomy (PCNL), which can significantly affect the final outcome of the procedure. Although the puncture of the kidney and subsequently dilatation of the tract has been commonly performed under fluoroscopic guidance [1]; renal access can also be established under ultrasonographic guidance (USG) with or without fluoroscopy.

To give a further insight into the role of both methods; in a prospective and randomised study published in this issue of the BJUI, Zhu et al. [2] have compared the safety and efficacy of fluoroscopic (FG), total ultrasonographic (USG), and combined ultrasonographic and fluoroscopic guidance (CG) for percutaneous renal access during mini-PCNL (mini-PCNL). In all, 450 consecutive patients with renal stones of >2 cm were randomised to undergo three different approaches during mini-PCNL. In addition to the stone-free rate (SFR) and blood loss as primary endpoints; access failure rate, operative time and complications were also evaluated. The S.T.O.N.E. [stone size (S), tract length (T), obstruction (O), number of involved calices (N), and essence or stone density (E)] scoring system was used for stone assessment [3] and the scores were further categorised into three grades (5–6, 7–8 and 9–13) for comparison.

While the overall operative complication rates, using the Clavien–Dindo grading system, were similar between the three groups; colonic injury treated with a temporary colostomy occurred in one case in the CG group. Although the SFRs were similar between the groups with S.T.O.N.E. scores of 5–6 and 9–13; the FG and CG approaches achieved significantly better SFRs than USG in patients with scores of 7–8, (P = 0.006). Multiple-tracts PCNL were used more frequently in the FG and CG group than USG group (P = 0.028). While the access failure rate was similar in the groups, the mean access time was longer in the CG group than in the FG and USG groups (P = 0.003). However, the mean total radiation exposure time was significantly greater for FG than for CG (47.5 vs 17.9 s, P < 0.001). The USG had zero radiation exposure. The operative time, hospital stay, nephrostomy drainage time, and the changes in the haemoglobin and creatinine levels were all similar in the three groups. The authors [1] concluded that mini-PCNL under total USG is as safe and effective as FG or CG in the treatment of simple kidney stones (S.T.O.N.E. scores 5–6) with no risk of radiation exposure. FG or CG is more effective for patients with S.T.O.N.E. scores of 7–8 where multiple percutaneous tracts may be necessary.

Percutaneous nephrolithotomy is now the preferred treatment method for larger stones (>2 cm) with successful outcomes. However, despite the high SFR obtained in a single session this approach can be associated with some severe complications such as bleeding, organ perforation, and sepsis. Such complications could be encountered during all steps of PCNL among which renal access seems to be the most critical one [4]. An appropriate puncture aiming a direct path from the skin through the papilla of the desired calyx of the kidney is of paramount importance to limit the above mentioned complications. Such an access to the renal collecting system can be established by either FG and/or USG. Although FG has been used commonly in the past; increasing experience in US applications has enabled endourologists to use this approach more often with some certain advantages in preventing renal puncture-related complications. When compared with FG, use of USG in establishing an access under vision allows the surgeon to identify the kidney pelvicalyceal system as well as the surrounding organs in a precise manner [5], with the benefit of minimising the risk of injury to such organs. Moreover, in addition to being free of ionising radiation; USG results in fewer punctures, has shorter operating times, and avoids contrast-related complications [1, 2]. Apart from helping to identify non-opaque residual stones at the end of the procedure; colour Doppler US can be used as a tool to localise the intrarenal arteries and avoid their puncture. However, the use of USG is an operator-dependent procedure requiring sufficient experience before routine performance and it may not be as efficient in the extremely obese patient and patients without hydronephrosis.

For the use of USG access in clinical practice, Agarwal et al. [5] reported a shorter mean time for successful puncture and significantly lower radiation exposure, yielding complete stone clearance with no substantial morbidity when compared with the FG technique. USG access was found also to increase puncture accuracy to a certain extent with a 96.5% SFR in another trial [6].

In conclusion, each of these techniques mentioned above have their own advantages and disadvantages. Despite its high success rate, radiation exposure and risk of multiple punctures are the main risks of the FG approach. USG renal access in experienced hands can produce high success rates following an appropriate puncture, lower risk of radiation exposure, and the ability to monitor all organs in the path of the puncture [7]. Depending on the surgeon’s experience, patient and stone-related factors, as well as the technical infrastructure, each approach may be used either alone or in combination for a complication-free and successful procedure. However, taking the above mentioned advantages of USG access into account, it is clear that all young urologist need to increase their experience in USG puncture to use it in appropriate cases (children, pregnant cases, dilated kidneys etc.) to lower the radiation risk and shorten the procedural duration.

Kemal Sarica, Professor of Urology, Chief

 

Department of Urology, Health Sciences University, Dr Lut Kirdar Kartal Research and Training Hospital, Istanbul, Turkey

 

References

 

1 Michel MS, Trojan L, Rassweiler JJ. Complications in percutaneous nephrolithotomy. Eur Urol 2007; 51: 899906

 

 

3 Okhunov Z, Friedlander JI, George AK et al. S.T.O.N.E. nephrolithometry: novel surgical classication system for kidney calculi. Urology 2013; 81: 115460

 

4 Aslam MZ, Thwaini A, Duggan B et al. Urologists versus radiologists made PCNL tracts: the UK experience. Urol Res 2011; 39: 21721

 

5 Agarwal M, Agrawal MS, Jaiswal A, Kumar D, Yadav H, Lavania PSafety and efcacy of ultrasonography as an adjunct to uoroscopy for renal access in percutaneous nephrolithotomy. BJU Int 2011; 108: 13469

 

6 BasiriA, Ziaee AM, Kianian HR, Mehrabi S, Ka rami H, Moghaddam SM. Ultrasonographic versus u oroscopic access for percutaneounephrolithotomy, a randomized clinical trial. J Enodourol 2008; 22: 28 14

 

7 Osman M, Wendt-Nordahl G, Heger K, Michel MS, Alken P, Knoll TPercutaneous nephrolithotomy with ultrasonography-guided renal access: experience from over 300 cases. BJU Int 2005; 96: 8758

 

Video: Comparing FG, USG and CG for renal access in mini-PCNL

A prospective and randomised trial comparing fluoroscopic, total ultrasonographic, and combined guidance for renal access in mini-percutaneous nephrolithotomy

Abstract

Objective

To compare the safety and efficacy of fluoroscopic guidance (FG), total ultrasonographic guidance (USG), and combined ultrasonographic and fluoroscopic guidance (CG) for percutaneous renal access in mini-percutaneous nephrolithotomy (mini-PCNL).

Patients and methods

The present study was conducted between July 2014 and May 2015 as a prospective randomised trial at the First Affiliated Hospital of Guangzhou Medical University. In all, 450 consecutive patients with renal stones of >2 cm were randomised to undergo FG, USG, or CG mini-PCNL (150 patients for each group). The primary endpoints were the stone-free rate (SFR) and blood loss (haemoglobin decrease during the operation and transfusion rate). Secondary endpoints included access failure rate, operating time, and complications. S.T.O.N.E. score was used to document the complexity of the renal stones. The study was registered at https://clinicaltrials.gov/ (NCT02266381).

Results

The three groups had similar baseline characteristics. With S.T.O.N.E. scores of 5–6 or 9–13, the SFRs were comparable between the three groups. For S.T.O.N.E. scores of 7–8, FG and CG achieved significantly better SFRs than USG (one-session SFR 85.1% vs 88.5% vs 66.7%, P = 0.006; overall SFR at 3 months postoperatively 89.4% vs 90.2% vs 69.8%, P = 0.002). Multiple-tracts mini-PCNL was used more frequently in the FG and CG groups than in the USG group (20.7% vs 17.1% vs 9.5%, P = 0.028). The mean total radiation exposure time was significantly greater for FG than for CG (47.5 vs 17.9 s, P < 0.001). The USG had zero radiation exposure. There was no significant difference in the haemoglobin decrease, transfusion rate, access failure rate, operating time, nephrostomy drainage time, and hospital stay among the groups. The overall operative complication rates using the Clavien–Dindo grading system were similar between the groups.

Conclusions

Mini-PCNL under USG is as safe and effective as FG or CG in the treatment of simple kidney stones (S.T.O.N.E. scores 5–6) but with no radiation exposure. FG or CG is more effective for patients with S.T.O.N.E. scores of 7–8, where multiple percutaneous tracts may be necessary.

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February Editorial: Raising the bar for systematic reviews with Assessment of Multiple Systematic Reviews (AMSTAR)

The BJUI has a longstanding track record in promoting the dissemination of high-quality unbiased evidence and helping their readership to understand why the principles of evidence-based medicine matter. This devotion is witnessed by the work that goes into every issue of the journal, as well as past initiatives such as providing a level of evidence rating for clinical research articles or publishing educational articles such as the ‘Evidence-Based Urology in Practice’ series [1, 2].

Major foci for clinically oriented specialty journals are systematic reviews and meta-analyses. Systematic reviews have a preeminent role in guiding the practice of evidence medicine by addressing focused clinical questions in a systematic, transparent and reproducible manner. Defining criteria of a high-quality systematic review include: an a priori registered protocol, a comprehensive search of multiple sources including unpublished studies (to avoid publication bias), an assessment of the quality of evidence that goes beyond study design alone, and a thoughtful interpretation of the findings. Systematic reviews inform clinicians and patients at the point of care, form the foundation of evidence-based clinical practice guidelines, and help shape health policy [3]. They also find frequent citation and can raise a journal’s impact factor. There is therefore more than one good reason for journals to care about the quality of systematic reviews.

Meanwhile, a study in this issue of the BJUI [4] shows that the methodological quality of systematic reviews published in the urological literature is modest, varies substantially, and has failed to improve over time. This contrasts to randomised controlled trials’ reporting quality that appears to have improved substantially over time, probably due to increased awareness among clinical researchers, urology readers and journal reviewers [4, 5]. The study [4] used the Assessment of Multiple Systematic Reviews (AMSTAR), a validated 11-item instrument, to measure the methodological quality of systematic reviews with higher scores reflecting better quality.

The authors [4] surveyed four major urological journals and compared the periods 2013–2015 to 2009–2012 and 1998–2008. Despite a dramatic increase in the number of systematic reviews published each year, methodological quality has stagnated with mean AMSTAR scores ± standard deviations of 4.8 ± 2.4 (2013–2015; = 125), 5.4 ± 2.3 (2009–2012; = 113) and 4.8 ± 2.0 (1998–2008; = 57). The average systematic review therefore has deficits in over half the 11 AMSTAR criteria and is of only modest quality thereby undermining our confidence in their results. Although the mean AMSTAR score of 5.6 ± 2.9 for 25 systematic reviews published in the BJUI in 2013–2015 compared favourably to similar studies in other leading urology journals, the difference was not statistically significant.

What are we going to do about it? Inspired by these findings, the BJUI is launching a new initiative to raise awareness for the issue of methodological quality of systematic reviews among its readership and raise the bars for its contributors. Future systematic review authors will be asked to submit an AMSTAR-based checklist to provide enhanced transparency about its methods that will be reviewed as part of the editorial review process. These include documentation of an a priori written protocol and ideally, registration of the systematic review through the Cochrane Collaboration or the Prospective Register of Systematic Reviews (PROSPERO). Such a protocol should outline all important steps of the review process including the definition of outcomes, study inclusion and exclusion criteria, details about the literature search, study selection and data abstraction process, analytical approach including planned sensitivity and subgroup analyses. Authors should also rate the quality of evidence looking beyond study limitation alone by using an approach such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE), which recognises such additional domains such as imprecision, inconsistency, indirectness and publication bias [6]. Critical steps of the systematic review process should be completed in duplicate to guard against random and systematic error and authors should provide readers with the information about who funded the studies included in the review, as well as their own potential conflicts of interests. To guard against publication bias, systematic review authors should also search for ongoing trials and unpublished studies through registries and abstract proceedings.

It is understood that the methodological handiwork that goes into the planning, execution and reporting of a systematic review do not assure clinical relevance or newsworthiness, nor does it address any issues surrounding the limited quality of studies that the review may be summarising. However, it is nevertheless a sine quae no to assure readers that they can be confident of the results. The new BJUI initiative will raise awareness for the issue of systematic review quality by providing a summary AMSTAR score to accompany each article. We hope that with this initiative we will provide a beacon for other specialty journals to follow, with the goal of raising the bar for all published systematic reviews and ultimately leading to improved patient care.

Philipp Dahm

 

Department of Urology, Minneapolis Veterans Administration Health Care System and University of Minnesota , MinneapolisMN, USA


References

 

1 Dahm P, Preminger GM. Introducing levels of evidence to publications in urology. BJU Int 2007; 100: 2467

 

 

 

4 HanJL, Gandhi S, Bockoven CG, Narayan VM, Dahm PThe landscape osystematic reviews in urology (1998 to 2015): an assessment of methodological quality. BJU Int 2016 [Epub ahead of print]. doi: 10.1111/bju.13653.

 

5 Narayan VM, Cone EB, Smith D, Scales CD Jr, Dahm P. Improved reporting of randomized controlled trials in the urologic literature. Eur Urol 2016; 70: 10449

 

6 Guyatt GH, Oxman AD, Vist GE et al. What is quality of evidence and why is it important to clinicians? BMJ 2008; 336: 9958

 

Article of the Month: Comparing health-related QoL outcomes for robotic cystectomy with those of traditional open radical cystectomy

Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Dipen Parekh discussing his paper. 

If you only have time to read one article this week, it should be this one.

Health-related quality of life from a prospective randomised clinical trial of robot-assisted laparoscopic vs open radical cystectomy

Jamie C. Messer, Sanoj Punnen*, John Fitzgerald, Robert Svatek and Dipen J. Parekh

Department of Urology, University of Texas Health Sciences Center at San Antonio, San Antonio, TX and *Department of Urology, Miller School of Medicine, University of Miami, Miami, FL, USA

Read the full article

Objective

To compare health-related quality-of-life (HRQoL) outcomes for robot-assisted laparoscopic radical cystectomy (RARC) with those of traditional open radical cystectomy (ORC) in a prospective randomised fashion.

Patients and Methods

This was a prospective randomised clinical trial evaluating the HRQoL for ORC vs RARC in consecutive patients from July 2009 to June 2011. We administered the Functional Assessment of Cancer Therapy–Vanderbilt Cystectomy Index questionnaire, validated to assess HRQoL, preoperatively and then at 3, 6, 9 and 12 months postoperatively. Scores for each domain and total scores were compared in terms of deviation from preoperative values for both the RARC and the ORC cohorts. Multivariate linear regression was used to assess the association between the type of radical cystectomy and HRQoL.

Results

At the time of the study, 47 patients had met the inclusion criteria, with 40 patients being randomised for analysis. The cohorts consisted of 20 patients undergoing ORC and 20 undergoing RARC, who were balanced with respect to baseline demographic and clinical features. Univariate analysis showed a return to baseline scores at 3 months postoperatively in all measured domains with no statistically significant difference among the various domains between the RARC and the ORC cohorts. Multivariate analysis showed no difference in HRQoL between the two approaches in any of the various domains, with the exception of a slightly higher physical well-being score in the RARC group at 6 months.

Conclusions

There were no significant differences in the HRQoL outcomes between ORC and RARC, with a return of quality of life scores to baseline scores 3 months after radical cystectomy in both cohorts.

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Editorial: Robotic and conventional open radical cystectomy lead to similar postoperative health-related quality of life

In this month’s issue of BJU International, Messer et al. [1] devise a prospective randomised trial to compare postoperative health-related quality of life (HRQoL) after robot-assisted (RARC) vs conventional open radical cystectomy (ORC). The investigators evaluated 40 patients over a follow-up period of 1 year and found no significant difference in HRQoL between surgical approaches. Moreover, they showed that the postoperative decrease in HRQoL returns to baseline within 3 months of surgery.

RC is one of the most challenging and potentially mutilating surgical interventions in the urological field and represents the standard-of-care treatment for patients with muscle-invasive bladder cancer. It is associated with a non-negligible risk of morbidity and mortality [2]. With the advent of new technologies, such as the Da Vinci surgical robot, carefully designed studies are needed to weigh the potential benefits of a novel approach against the increased costs associated with such tools. While RARC holds the promise of combining the benefits of a minimally invasive intervention with the precise robotic translation of the surgeon’s movements, these claims remain to be definitely proven in the clinical setting. As such, further elucidating the effect of surgical approach on perioperative outcomes after RC is essential for treatment planning, patient counselling and informed decision-making before surgery.

QoL is increasingly used as a quantitative measure of treatment success [3, 4]. These measures are gaining considerable traction in the USA, as reimbursements will soon be tied to patient satisfaction. While previous retrospective studies suggest that RARC has comparable perioperative oncological outcomes with potentially lower morbidity relative to ORC [5], there is a scarcity of high-quality evidence on HRQoL outcomes of RARC vs ORC. The difficulties of conducting randomised trials in the surgical setting are reflected by the relatively few participants in the Messer et al. [1] trial. Nonetheless, in their pilot study, the authors demonstrated the feasibility of a HRQoL trial in RC patients. Furthermore, they deliver initial evidence on the impact of surgical approach on HRQoL after RC.

From a clinical perspective, the authors contribute interesting findings to the ongoing debate. Their results suggest that the potential benefits of robot-assisted surgery on HRQoL may be limited in patients undergoing complex oncological surgery such as RC. Several hypotheses may be pertinent to their conclusions. For example, performing an open urinary diversion after RARC that can take as much time as the actual extirpative RC may mitigate any potential benefit of the minimally invasive approach. Furthermore, the study findings may be largely influenced by the surgical skills of the participating surgeons. Maybe the correct interpretation of their study findings is that there was no significant difference in HRQoL outcomes between ORC and RARC, at the institution where the trial was performed.

Nonetheless, the authors suitably demonstrate the feasibility of performing a randomised trial in this field and pave the way towards adequately powered, randomised multicentre trials that can provide further evidence on what impact RARC may have on perioperative outcomes and beyond.

Read the full article

Julian Hanske, Florian Roghmann, Joachim Noldus and Quoc-Dien Trinh*

Department of Urology, Marien Hospital, Ruhr-University Bochum, Herne, Germany, and *Division of Urologic Surgery and Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

References

1 Messer JC, Punnen S, Fitzgerald J, Svatek R, Parekh DJ. Health-related quality of life from a prospective randomised clinical trial of robot-assisted laparoscopic vs open radical cystectomy. BJU Int 2014; 114: 896–902

2 Roghmann F, Trinh QD, Braun K et al. Standardized assessment of complications in a contemporary series of European patients undergoing radical cystectomy. Int J Urol 2014; 21: 143–9

3 Cookson MS, Dutta SC, Chang SS, Clark T, Smith JA Jr, Wells N. Health related quality of life in patients treated with radical cystectomy and urinary diversion for urothelial carcinoma of the bladder: development and validation of a new disease specific questionnaire. J Urol 2003; 170: 1926–30

4 Loppenberg B, von Bodman C, Brock M, Roghmann F, Noldus J, Palisaar RJ. Effect of perioperative complications and functional outcomes on health-related quality of life after radical prostatectomy. Qual Life Res 2014. doi: 10.1007/s11136-014-0729-1

5 Kader AK, Richards KA, Krane LS, Pettus JA, Smith JJ, Hemal AK. Robot-assisted laparoscopic vs open radical cystectomy: comparison of complications and periopera

 

Video: Robot-assisted laparoscopic vs open radical cystectomy – health-related QoL from a prospective randomised clinical trial

Health-related quality of life from a prospective randomised clinical trial of robot-assisted laparoscopic vs open radical cystectomy

Jamie C. Messer, Sanoj Punnen*, John Fitzgerald, Robert Svatek and Dipen J. Parekh

Department of Urology, University of Texas Health Sciences Center at San Antonio, San Antonio, TX and *Department of Urology, Miller School of Medicine, University of Miami, Miami, FL, USA

Read the full article

Objective

To compare health-related quality-of-life (HRQoL) outcomes for robot-assisted laparoscopic radical cystectomy (RARC) with those of traditional open radical cystectomy (ORC) in a prospective randomised fashion.

Patients and Methods

This was a prospective randomised clinical trial evaluating the HRQoL for ORC vs RARC in consecutive patients from July 2009 to June 2011. We administered the Functional Assessment of Cancer Therapy–Vanderbilt Cystectomy Index questionnaire, validated to assess HRQoL, preoperatively and then at 3, 6, 9 and 12 months postoperatively. Scores for each domain and total scores were compared in terms of deviation from preoperative values for both the RARC and the ORC cohorts. Multivariate linear regression was used to assess the association between the type of radical cystectomy and HRQoL.

Results

At the time of the study, 47 patients had met the inclusion criteria, with 40 patients being randomised for analysis. The cohorts consisted of 20 patients undergoing ORC and 20 undergoing RARC, who were balanced with respect to baseline demographic and clinical features. Univariate analysis showed a return to baseline scores at 3 months postoperatively in all measured domains with no statistically significant difference among the various domains between the RARC and the ORC cohorts. Multivariate analysis showed no difference in HRQoL between the two approaches in any of the various domains, with the exception of a slightly higher physical well-being score in the RARC group at 6 months.

Conclusions

There were no significant differences in the HRQoL outcomes between ORC and RARC, with a return of quality of life scores to baseline scores 3 months after radical cystectomy in both cohorts.

Read more articles of the week
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