Year: 2015

Further Randomised Controlled Trials are needed….No! say something original.

June 12, 2015/11 Comments/by Ben Challacombe

“As we all know, prostate/kidney/bladder cancer is a common disease…” aaargh!!! Of course it is, that’s why you are writing about it and trying to get this piece of work into this journal and why everyone who reads it might be interested; because it is so important and common! If we all know it anyway why are you bothering to tell us this whilst wasting time and your word count and not getting on with presenting the actual research? Anyone who doesn’t know that prostate cancer is pretty common isn’t a doctor let alone a urologist. This is found more often than I can stand and got me thinking about all the other scientific catchphrases and tactics that serve more to irritate than inform.

As the BJUI associate editor for Innovation and one of the triage editors, I read around 600 BJUI submissions each year as part of my role. This is not to mention the additional manuscripts I formally review for this journal and others and there are certain phrases and statements that really just make my blood boil. Time and time again the same statements come up that are put into medical papers seemingly without any thought and which add nothing other than serving to irritate the editor, reviewer and reader.

The throwaway statement that “further randomised trials are needed” is often added to the end of limited observational and cohort studies, presumably by young researchers and almost never adds anything. Anyone who has ever been involved with a surgical RCT will know how challenging it is to set one up and run one, let alone recruit to one which is why so few exist and why so many have failed. Just saying more RCTs are needed without thought to why they haven’t already been carried out just frustrates the reader and shows a lack of true comprehension of the subject. Suggesting an valid alternative to an RCT however might actually get people thinking.

So what else is in the wastebucket of things that cause journal irritation? Well conclusions that have no basis in the results that have been shown; such as XXX is a safe and generally acceptable procedure after 3 cases, of which one had a 2 litre blood loss; or we advise everyone to switch to our technique on the basis of this uncontrolled retrospective cohort. Another is YY is the “Gold Standard” even though this is just opinion that is usually very outdated and this way of doing things was really only the standard approach 20 years ago!

Failure to acknowledge the study limitations is another area that particularly winds me up especially when the authors did a procedure one way 500 times then subsequently did it 50 times in a subtly different way and state that the second is better without mentioning that they might have learnt a fair bit from the previous huge number of cases!

So please let me know what irritates you in a paper so I can watch out for it and makes sure never to use it myself

Ben Challacombe
Associate Editor, BJUI

Learning from The Lancet

June 12, 2015/by admin Z.9

The Lancet, established in 1823, is one of the most respected medical journals in the world. It has an impact factor of 39, and therefore attracts and publishes only the very best papers. Like most journals that have evolved with modern times, it has an active web and social media presence, particularly based around Twitter.

On a Monday morning, last autumn, the Editor of the BJUI had a meeting with the Web Editor of The Lancet at Guy’s Hospital. There was a mutual interest in surgical technology, particularly as Naomi Lee had been a urology trainee before joining The Lancet full-time. The topic of discussion was robot-assisted radical cystectomy with the emergence of randomised trials showing little difference between open and robotic surgery, despite the minimally invasive nature of the latter [1, 2]. Thereafter, The Lancet kindly invited the BJUI team to visit its offices in London. The location is rather bohemian with a mural of John Lennon on the wall across the street! Here is a summary of what we learnt that day.

1. Democracy – what gets published in The Lancet after peer review is decided at a team meeting, where editors of the main journal and its sister publications gather around a table to discuss individual articles. Most work full-time for The Lancet, unlike surgical journals that are led by working clinicians. No wonder that >80% of papers are immediately rejected and the final acceptance rate is ≈6%. Interesting case reports are still published and often highly cited because of the wider readership.

2. Quality has no boundaries – it does not matter where the article comes from as long as it has an important message. The BJUI recently published an excellent paper on circumcision in HIV-positive men from Africa [3]; the original randomised controlled trial had appeared some 7 years earlier in The Lancet [4].

3. Statisticians – the good ones are a rare breed and sometimes rather difficult to find. While we have two statistical editors at the BJUI, sometimes, it is difficult to approach the most qualified reviewer on a particular subject. The Lancet occasionally faces similar difficulties, which it almost always overcomes due to its’ team approach.

4. Meta-analysis and systematic reviews – they form a significant number of submissions to both journals. It is not always easy to judge their quality although a key starting point is to identify whether the topic is one of contemporary interest where there are significant existing data that can be analysed. Rare subjects usually fail to make the cut.

5. Paper not dead yet – this is certainly the case at The Lancet office, where its editors gather together with paper folders and hand-written notes. We are almost fully paperless at the BJUI offices, and are hoping to be completely electronic in the future. A recent live vote of our readership during the USANZ Annual Scientific Meeting in Adelaide, Australia, indicated that the majority would like us to go electronic in about 2–3 years’ time; however, ≈30% of our institutional subscribers still prefer the paper version and are reluctant to make the switch.

The BJUI and The Lancet are coming together to host a joint Social Media session at BAUS 2015, which will provide more opportunity to learn from one of the best journals ever. We hope to see many of you there.

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 Lee N. Robotic surgery: where are we now? Lancet 2014; 384: 1417

3 Kigozi G, Musoke R, Kighoma N et al. Male circumcision wound healing in human immunodeﬁciency virus (HIV)-negative and HIV-positive men in Rakai, Uganda. BJU Int 2014; 113: 127–32

4 Gray RH, Kigozi G, Serwadda D et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet 2007; 369: 657–66

Prokar Dasgupta @prokarurol

Editor-in-Chief, BJUI

Scott Millar

Managing Editor, BJUI

Naomi Lee

Web Editor, The Lancet

Favourite AUA Venue Poll Results 2015

June 10, 2015/by admin Z.9

Article of the Week: Renal Function is the same regardless of clamp technique 6 months after RAPN

June 10, 2015/by admin Z.9

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 Prof. Rha, discussing his paper.

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

Renal Function is the same regardless of clamp technique 6 months after Robot-assisted Partial Nephrectomy: Analysis of Off-Clamp, Selective Arterial Clamp and Main Artery Clamp with minimum of 1 year follow-up.

Christos Komninos*‡, Tae Young Shin†, Patrick Tuliao*, Woong Kyu Han*, Byung Ha Chung*, Young Deuk Choi* and Koon Ho Rha*

*Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, †Department of Urology, Chuncheon Sacred Hospital, Hallym Medical College, Chuncheon, Korea, and ‡Department of Urology, General Hospital of Nikaia ‘St. Panteleimon’, Athens, Greece

Read the full article

OBJECTIVE

To compare the renal functional outcomes, with >1 year of follow-up, of patients who underwent robot-assisted partial nephrectomy (RAPN) performed with different clamping techniques.

PATIENTS AND METHODS

The peri-operative data of patients undergoing RAPN performed with different clamping techniques were retrospectively analysed (group 1: off-clamp, n = 23; group 2: selective clamp, n = 25; group 3: main artery clamp, n = 114). The main outcome measures were postoperative serum creatinine level, estimated glomerular filtration rate (eGFR) and percentage change in eGFR, the data for which were collected at periodic intervals during the first 12 months and annually thereafter, in addition to late eGFR value. Only patients with >1 year of follow-up were included in the analysis.

RESULTS

The baseline characteristics of groups 2 and 3 were similar, while patients in group 1 had smaller sized tumours and lower tumour complexity. The median follow-up periods were 45 (group 1), 20 (group 2) and 47 (group 3) months. The median clamping times were 24.8 min in the main artery clamp and 18 min in the selective artery clamp groups. Group 2 had greater median blood loss volume (100 vs 500 vs 200 mL for groups 1, 2 and 3, respectively; P < 0.01) and a longer length of hospital stay (3 vs 4 vs 3 days for groups 1, 2 and 3, respectively; P = 0.02). No significant differences were found among the groups with regard to transfusion rates, positive surgical margin rates, complications, recurrence or mortality rates. Groups 1 and 2 had significantly less deterioration of postoperative renal function during the first 3 months after surgery (P = 0.04; percent change in eGFR −1.5, −2 and −8% for groups 1, 2 and 3, respectively), but this beneficial outcome was not observed after 6 months or for the latest eGFR measurement (P = 0.48; latest percent change in eGFR −3, −6 and −3.5% for groups 1, 2 and 3, respectively). In regression analysis, baseline eGFR, type of clamp procedure and tumour complexity score were predictive of normal renal function 7 days after surgery, while only baseline eGFR and age could predict it 1 year postoperatively.

CONCLUSIONS

Off-clamp and selective artery clamp techniques result in superior short-term renal functional outcomes compared with the main artery clamp approach; however, after the 6th postoperative month, there were no significant differences regarding the functional outcome among the above surgical techniques, as long as the warm ischaemia time was 20–30 min.

Editorial: To clamp or not to clamp in robotic partial nephrectomy?

June 10, 2015/by Ben Challacombe

The article by Komninos et al. [1], in this issue of the BJUI has looked into the importance of warm ischaemia techniques in robot-assisted partial nephrectomy (RAPN) on the deterioration in short- and longer-term renal function. A case series of 162 procedures undertaken by a single surgeon over a 7-year period was analysed. Within this cohort, 114 patients underwent main artery clamping, whilst 23 and 25 patients underwent off-clamp and selective artery clamping methods, respectively.

Segmental artery clamping and off-clamp techniques have been recently developed to minimize the warm ischaemia time (WIT), which, if prolonged, can result in loss of normal functioning parenchyma, potentially causing renal impairment [2]. This paper has correctly identified that many studies on RAPN within the literature have a limited 6-month follow-up regarding postoperative renal function, and the authors sought to evaluate this further. They have shown that significantly less deterioration in renal function over the first 3 months is seen in the off-clamp and selective artery clamp techniques compared with main artery clamping. Importantly, however, this reduction seems transient and was not seen at 6 months and 1 year after surgery.

The authors comment on the median clamping times used in the two separate clamping techniques, with 24.8 and 18 min in the main artery and selective artery clamping groups, respectively; however, no specific analysis was provided of the significance of these times on renal function outcome. Elsewhere Abreu et al. [3], have reported that ‘zero ischaemia time’, with no hilar clamping, preserves renal function with a median decrease of 0 mg/dL in creatinine and a 5 mL/min/1.73 m² reduction in estimated GFR (eGFR) rate at hospital discharge in a robotic surgery series. Similarly, George et al. [4] have shown that, at 6 months, less renal injury is sustained, as demonstrated by eGFR, when an off-clamp laparoscopic technique was used compared with an on-clamp technique, and that WIT was a significant predictor of decreased eGFR in the postoperative period.

Warm ischaemia time is a topic of much debate in the literature and remains a controversial area of significant interest. As most predictors of eGFR, such as age, comorbidity and pre-existing renal function, are unmodifiable, the attractive challenge with WIT is that it is a surgically modifiable variable. Reassuringly, RAPN clamp time is typically shorter than in pure laparoscopic partial nephrectomy, and usually shorter than the generally accepted limit of 30 min that has been associated with good preservation of postoperative renal function [5]. More recently, Wiener et al. [6] were able to establish that WIT ≤ 22 min prevented a statistically significant decline in renal function at 6–12 months.

In light of this evidence, another technique of ‘early unclamping’ is being increasingly considered, especially in RPN, but several considerations, including increased blood loss and potential increased difficulty with the renorrhaphy, have limited its application [5]. The paper by Komninos et al. is supported by another study that analysed 95 consecutive RAPN cases, in which a variety of clamping techniques was used (artery and vein, artery alone and unclamp), showing that GFR and overall percentage decrease in GFR was similar for all three methods at a median follow-up of 6 months and suggesting that intermediate-term renal function outcome is irrespective of clamping technique [7].

Clearly there are limitations to the present study, including its non-randomized, retrospective nature and the low sample sizes of the off-clamp and selective artery groups and the authors have recognized this. The entire population also had a low body mass index and comorbidity status compared with many RAPN series. The off-clamp tumours were all relatively exophytic, significantly smaller than the other groups (1.7 vs 3.5 and 3.3 cm), and far less complex, with PADUA scores of 7 compared with 10 and 9. Despite this, the study has shown, with a respectable follow-up period, that although there is a significant initial deterioration in renal function with the main artery clamping technique at 3 months compared with the selective artery and off-clamp methods, there was no significant difference in renal deterioration between the three groups at 6 months and at 1 year.

It is also interesting to see that, even though patients in the main artery clamping group had larger and more complex tumours, inevitably resulting in a greater resected volume of normal-functioning nephrons, renal function deterioration was no different from the off-clamp group by 6 months. The authors have contributed to the evidence for main artery clamping in RPN, particularly in complex tumours in healthy younger patients with bilateral functioning renal units. Techniques to minimize warm ischaemia are likely to continue to have a role in higher risk and imperative indications for partial nephrectomy.

Read the full article

Buket N. Ertansel, Norbert Doeuk and Ben Challacombe

Guy’s & St Thomas’s Hospital, London, UK

References

1 Komninos C, Shin TY, Tuliao P et al. Renal Function is the same regardless of clamp technique 6 months after Robot-assisted Partial Nephrectomy: analysis of Off-Clamp, Selective Arterial Clamp and Main Artery Clamp with minimum of 1 year follow-up. BJU Int 2014; doi: 10.1111/bju.12975. [Epub ahead of print]

2 Thompson RH, Lane BR, Lohse CM et al. Every minute counts when the renal hilum is clamped during partial nephrectomy. Eur Urol 2010; 58: 340–5

3 Abreu AL, Gill IS, Desai MM. Zero-ischaemia robotic partial nephrectomy (RPN) for hilar tumours. BJU Int 2011; 108 (Pt 2): 948–54

4 George AK, Herati AS, Srinivasan AK et al. Perioperative outcomes of offclamp vs complete hilar control laparoscopic partial nephrectomy. BJU Int 2013; 111 (Pt B): E235–41

5 Cawley O, Roman A, Brown M, Challacombe B. Exploring the evidence for early unclamping during robot-assisted partial nephrectomy: is it worth the time and effort? BJU Int 2014; doi: 10.1111/bju.12836. [Epub ahead of print]

6 Wiener S, Kiziloz H, Dorin RP, Finnegan K, Shichman SS, Meraney A. Predictors of postoperative decline in estimated glomerular ﬁltration rate in patients undergoing robotic partialnephrectomy. J Endourol 2014; 28: 807–13

7 Krane LS, Mufarrij PW, Manny TB, Hemal AK. Comparison of clamping technique in robotic partial nephrectomy: does unclamped partial nephrectomy improve perioperative outcomes and renal function? Can J Urol 2013; 20: 6662–7

Video: 6 months after RAPN – Renal Function is the same regardless of clamp technique

June 10, 2015/by admin Z.9