Correspondence
All authors contributed equally to this
Correspondence. PK is a research fellow, JWFC is the
chief investigator, and JDK is a co-investigator for
the iROC trial. PK is funded by The Urology
Foundation, and JDK is funded by the Biomedical
Research Centre.
*Pramit Khetrapal, James W F Catto,
John D Kelly, on behalf of the iROC Trial
Management Group
p.khetrapal@ucl.ac.uk
Division of Surgery & Interventional Science,
University College London, London NW1 2FD, UK
(PK, JWFC, JDK); Department of Urology, University
College Hospital at Westmoreland Street, London,
UK (PK, JDK); and Academic Urology Unit, University
of Sheffield, Sheffield, UK (JWFC)
1 Parekh DJ, Reis IM, Castle EP, et al. Robot-assisted
radical cystectomy versus open radical
cystectomy in patients with bladder cancer
(RAZOR): an open-label, randomised, phase 3,
non-inferiority trial. Lancet 2018; 391: 2525–36.
2 Tan WS, Khetrapal P, Tan WP, Rodney S,
Chau M, Kelly JD. Robotic assisted radical
cystectomy with extracorporeal urinary
diversion does not show a benefit over open
radical cystectomy: a systematic review and
meta-analysis of randomised controlled trials.
PLoS One 2016; 11: e0166221.
3 Wilson TG, Guru K, Rosen RC, et al. Best practices
in robot-assisted radical cystectomy and urinary
reconstruction: recommendations of the
pasadena consensus panel. Eur Urol 2015;
67: 363–75.
4 Khadhouri S, Miller C, Cresswell J, et al.
The BAUS radical cystectomy audit 2014—an
update on current practice and an analysis of
the effect of centre and surgeon case volume.
Eur Urol Suppl 2017; 16: e473–74.
5 Catto JWF, Khetrapal P, Ambler G, et al.
Multidomain quantitative recovery following
radical cystectomy for patients within the
robot-assisted radical cystectomy with
intracorporeal urinary diversion versus open
radical cystectomy randomised controlled trial:
the first 30 patients. Eur Urol 2018; 74: 531–34.
We read with interest the Article by
Parekh and colleagues,1 who report non-
inferior 24-month progression-free
survival following robot-assisted versus
open radical cystectomy. Previous
investigations questioned the role of
robot-assisted radical cystectomy for
two main reasons: high costs and risk
of early cancer dissemination due to
spillage.2,3 Although cost-effectiveness
analysis has not been carried out, this
prospective, randomised trial clearly
demonstrated the same early cancer
recurrences after either treatment
method.
Furthermore, no difference was
found in 3-month complications,
which were investigated as a
www.thelancet.com Vol 393 February 16, 2019
secondary outcome of the trial,
questioning the clinical value of
robot-assisted surgery for bladder
cancer. However, this trial might
instead represent a possible step in
favour of implementation of robot-
assisted radical cystectomy in clinical
practice. The reconstructive phase of
radical cystectomy is the major driver
of perioperative morbidity,4 especially
for clinically relevant adverse events.5
In RAZOR, robot-assisted radical
cystectomy was invariably followed
by extracorporeal reconstruction and
no single patient was treated with
robot-assisted intracorporeal urinary
diversion, although its use increased
from 9% in 2005 to 97% in 2015
in selected centres.6 Therefore, the
possible benefit of minimally invasive
surgery to really reduce perioperative
morbidity has not been tested in this
trial, and these results were certainly
predictable.
Of note, robot-assisted radical
cystectomy was associated with
significantly lower blood loss and
trans­ fusion rates relative to open
radical cystectomy. The comparable
oncological outcomes coupled with
much better intra-operative profiles
might thus allow us to interpret RAZOR
as a trial in favour of robot-assisted
radical cystectomy. To what extent does
an extracorporeal urinary diversion
dilute the potential advantage of
robot-assisted radical cystectomy?
Given oncological equipoise, the
answer to this question, together
with methodologically sound cost-
effectiveness analyses are crucial to
define the role of robot-assisted surgery
in the setting of bladder cancer.
AL reports grants from Intuitive and non-financial
support from Medtronic, outside the submitted
work. AM reports personal fees from Intuitive,
outside the submitted work. All other authors
declare no competing interests.
*Alessandro Larcher, Giorgio Gandaglia,
Peter Wiklund, Alexandre Mottrie,
Alberto Briganti, Francesco Montorsi,
on behalf of the European Association
of Urology Robotic Urology Section
alelarcher@gmail.com
Department of Urology, Division of Oncology,
Urological Research Institute, IRCCS Ospedale
San Raffaele, 20132 Milan, Italy (AL, GG, AB, FM);
ORSI Academy, Melle, Belgium (AL, AM);
Department of Urology, Onze Lieve Vrouw Hospital,
Aalst, Belgium (AL, AM); Department of Urology,
Karolinska University Hospital, Stockholm, Sweden
(PW); and Department of Urology, Icahn School of
Medicine at Mt Sinai, New York, NY, USA (PW)
1 Parekh DJ, Reis IM, Castle EP, et al. Robot-assisted
radical cystectomy versus open radical
cystectomy in patients with bladder cancer
(RAZOR): an open-label, randomised, phase 3,
non-inferiority trial. Lancet 2018; 391: 2525–36.
2 Nguyen DP, Al Hussein Al Awamlh B, Wu X,
et al. Recurrence patterns after open and
robot-assisted radical cystectomy for bladder
cancer. Eur Urol 2015; 68: 399–405.
3 Nguyen DP, Al Hussein Al Awamlh B,
O’Malley P, et al. Factors impacting the
occurrence of local, distant and atypical
recurrences after robot-assisted radical
cystectomy: a detailed analysis of 310
patients. J Urol 2016; 196: 1390–96.
4 Satkunasivam R, Wallis CJD, Nam RK, Desai M,
Gill IS. Contemporary evidence for
robot-assisted radical cystectomy for treating
bladder cancer. Nat Rev Urol 2016; 13: 533–39.
5 Hussein AA, Hashmi Z, Dibaj S, et al.
Reoperations following robot-assisted radical
cystectomy: a decade of experience. J Urol 2016;
195: 1368–76.
6 Hussein AA, May PR, Jing Z, et al. Outcomes of
intracorporeal urinary diversion after
robot-assisted radical cystectomy: results from
the International Robotic Cystectomy
Consortium. J Urol 2018; 199: 1302–11.
Authors’ reply
We read with great interest the com­
ments from Larcher and colleagues
and Khetrapal and colleagues and
appreciate their interest.
Aberration Films Ltd/Science Photo Library
Cost analysis is essential in evaluating
the exact role of robotic cystectomy,
however, owing to the limitations we
described inherent to cost reporting
practices within North American health
systems, we were unable to do this. The
indirect costs of the two procedures
are worth keeping in mind, given that
most robotic surgery patients will
have a shorter hospital stay and fewer
blood transfusions, although they take
longer to perform. Furthermore, we
hope that as newer robotic systems
enter the marketplace some of the
cost differential will be mitigated.
The suggestion by Khetrapal and
colleagues that surgeons in the RAZOR
trial1 were still on their learning curve is
pure speculation. There is no universally
accepted learning curve for cystectomy
645
 Correspondence
based on any prospective studies.
Although participation in RAZOR
required at least ten cystectomies in the
preceding year before trial enrolment,
most surgeons did substantially more
and were high-volume surgeons in
both approaches. The high quality of
surgical surrogates we reported, namely
lymph node yield, positive margins, and
complication rates, are a testament to
this. The iROC trial2 requires surgeons
to have done 30 or more intracorporeal
diversions in their entire career, with
accredited surgeons required to have
performed more than ten radical
cystectomies per year in the past 2 years
as primary surgeon, which does not
seem remarkably different. Most of the
participating surgeons in the RAZOR
trial had performed substantially more
than 30 radical cystectomies (using
either approach) in their career.
Operating time in RAZOR was
defined as the time from patient entry
to the time they exited the operating
theatre. In most instances the time
for positioning and anaesthesia
(preparation and induction) before
making any incision and the time
Mohamed Nureldin Abdallah/Reuters Pictures
after closure for extubation and
leaving the theatre is generally around
60–80 min indicating that RAZOR times
are competitive with contemporary
retrospective studies that mainly use
incision to closure as operating time.
As Larcher and colleagues mention,
Published Online the morbidity of radical cystectomy is
January 28, 2019 mostly driven by the reconstruction
http://dx.doi.org/10.1016/
S0140-6736(19)30161-8 performed (ie, continent vs incon­
tinent). Because these recon­structions
were well balanced, we do not believe
that complication rates could be
affected.
Both sets of authors seem to
believe that the true value of robotic
cystectomy lies in an intracorporeal
diversion. RAZOR commenced in
Published Online 2011 and was in planning from 2009.
February 8, 2019 Intracorporeal diversions were very
http://dx.doi.org/10.1016/
S0140-6736(19)30277-6
much in the nascent stage at that
time and there was no rationale to
use them. Even today, intracorporeal
diversion in the USA is restricted to
select centers because of the long
646
learning curve and no prospective
randomised data exist favouring it. We
await with great interest the results
of the iROC trial, which is a step in the
right direction, and congratulate the
investigators in advance.
We declare no competing interests.
*Dipen J Parekh, Vivek Venkatramani,
on behalf of RAZOR trial authors
parekhd@miami.edu
Miller School of Medicine, University of Miami,
Miami, FL, USA
1 Parekh DJ, Reis IM, Castle EP, et al. Robot-assisted
radical cystectomy versus open radical
cystectomy in patients with bladder cancer
(RAZOR): an open-label, randomised, phase 3,
non-inferiority trial. Lancet 2018; 391: 2525–36.
2 Catto JWF, Khetrapal P, Ambler G, et al.
Multidomain quantitative recovery following
radical cystectomy for patients within the
robot-assisted radical cystectomy with
intracorporeal urinary diversion versus open
radical cystectomy randomised controlled trial:
the first 30 patients. Eur Urol 2018; 74: 531–34.
Hospitals attacked in
Khartoum, Sudan
The Lancet recently highlighted the
humanitarian crisis in Sudan (Jan 19,
p 199).1 In the past weeks, tens of
thousands of people across Sudan have
been reported to have taken to the
streets, calling for an end to President
Omar al-Bashir’s 30-year rule.2 According
to credible reports received by Amnesty
International, security forces had killed
37 protestors by Dec 24, 2018.3 The
violent crackdown escalated, with
security forces reportedly attacking
hospitals in Omdurman on Jan 9, 2019,
and Bahri on Jan 13, 2019.4,5 Crossing
the threshold of hospital grounds is a
saddening precedent for a government
response that appears to deliberately
target health professionals through
violence and detention.­6,7
That Sudan had repeated out­breaks of
yellow fever, cholera, and Chikungunya,
reported as recently as October, 2018,8,9
suggests a vulnerability of Sudan’s
neglected health system. This is in a
country whose ruler was alleged in 2010
to have stashed billions of dollars in
UK bank accounts.10 As Sudan’s health
professionals use their voices and bodies
to peacefully demand a better health
system, the international community
should amplify these calls and hold the
government to account when they
shamefully defy norms by attacking
hospitals, patients, and clinicians.
I declare no competing interests.
Majdi Osman
majdi.osman@mail.harvard.edu
Harvard Medical School, Boston, MA 02144, USA
1 The Lancet. Sudan’s threatened health and
humanitarian crisis. Lancet 2019; 393: 199.
2 The Economist. Sudan’s genocidal regime is
under siege. Jan 10, 2019. https://www.
economist.com/middle-east-and-
africa/2019/01/12/sudans-genocidal-regime-
is-under-siege (accessed Jan 15, 2019).
3 Amnesty International. 37 protesters shot
dead by security forces in Sudan. Dec 24, 2018.
https://www.amnesty.org/en/latest/
news/2018/12/sudan-protesters-dead-in-
government-crackdown-on-protests/
(accessed Jan 13, 2019).
4 Reuters. Sudanese forces fire tear gas to break
up Omdurman protests. Jan 10, 2019.
https://af.reuters.com/article/
commoditiesNews/idAFL8N1ZA0IC
(accessed Jan 13, 2019).
5 Alamin M. Sudan’s Bashir defies calls to step
down as pressure mounts. Jan 14, 2019.
https://www.bloomberg.com/news/
articles/2019-01-14/sudan-doctors-slam-
police-targeting-of-hospitals-during-protests
(accessed Jan 14, 2019).
6 Amnesty International. Sudan: ‘horrific attack’ on
hospital targets injured protesters. Jan 10, 2019.
https://www.amnesty.org.uk/press-releases/
sudan-horrific-attack-hospital-targets-injured-
protesters (accessed Jan 21, 2019).
7 Human Rights Watch. Sudan: hundreds of
protesters arrested. Jan 18, 2019. https://www.
hrw.org/news/2019/01/18/sudan-hundreds-
protesters-arrested (accessed Jan 21, 2019).
8 WHO Regional Office for the Eastern
Mediterranean. Sudan health profile 2015.
Geneva: World Health Organization, 2017.
9 WHO. Chikungunya—Sudan. Disease outbreak
news. Oct 15, 2018. https://www.who.int/csr/
don/15-october-2018-chikungunya-sudan/en/
(accessed Jan 21, 2019).
10 Hirsch A. WikiLeaks cables: Sudanese president
‘stashed $9bn in UK banks’. Dec 17, 2010.
https://www.theguardian.com/world/2010/
dec/17/wikileaks-sudanese-president-cash-
london (accessed Jan 15, 2019).
Department of Error
Bleakley T, Smith R, Taylor R. Has the NHS Long
Term Plan forgotten we are all going to die? Lancet
2019; 393: 387–89—In this Comment, the
seventh sentence of the third paragraph should
read: “Furthermore, increases in life expectancy
have stalled and life expectancy has actually
decreased in some groups, such as women in
deprived areas.” This correction has been made
to the online version as of Feb 8, 2019.
www.thelancet.com Vol 393 February 16, 2019