correspondence

chloroquine and prednisone for mixed connective-tissue disease and is doing very well.
Kai Saukkonen, M.D.
Massachusetts General Hospital
Boston, MA
Since publication of his article, the author reports no further
potential conflict of interest.
1. Komatireddy GR, Wang GS, Sharp GC, Hoffman RWJ. Anti-

phospholipid antibodies among anti-U1-70 kDa autoantibody

positive patients with mixed connective tissue disease. J Rheumatol 1997;24:319-22.

2. Venables PJ. Mixed connective tissue disease. Lupus 2006;

15:132-7.
3. Dorfmller P, Humbert M, Perros F, et al. Fibrous remodeling of the pulmonary venous system in pulmonary arterial hypertension associated with connective tissue diseases. Hum
Pathol 2007;38:893-902.
4. Zhang L, Visscher D, Rihal C, Aubry MC. Pulmonary venoocclusive disease as a primary cause of pulmonary hypertension
in a patient with mixed connective tissue disease. Rheumatol Int
2007;27:1163-5.
DOI: 10.1056/NEJMc1404715

A Randomized Trial of Robot-Assisted Laparoscopic

Radical Cystectomy
To the Editor: Radical cystectomy is the standard management of nonmetastatic, invasive bladder cancer. However, this treatment is associated
with clinically significant perioperative complications and prolonged recovery time among patients with this disease, who are typically older
and often have a history of smoking and coexisting conditions.1,2 Retrospective studies indicate
that robot-assisted laparoscopic surgery is associated with a reduced risk of complications and
shorter hospital stay, as compared with open surgery,3 but data are lacking from randomized trials.
We report the results of a randomized, controlled
trial (ClinicalTrials.gov number, NCT01076387)
designed to assess whether robot-assisted laparoscopic radical cystectomy would be associated
with a lower rate of perioperative complications
than open surgery (with the technique of extracorporeal urinary diversion used in both approaches); the study protocol is available with the
full text of this letter at NEJM.org.

Patients with bladder cancer of clinical stage

Ta3N03M0 (according to the 2010 tumor
nodemetastasis [TNM] classification system
from the American Joint Committee on Cancer
and the International Union against Cancer)
who were scheduled for definitive treatment
with the use of radical cystectomy were recruited
at Memorial Sloan Kettering Cancer Center from
March 2010 through March 2013. Four surgeons
with experience in open surgery performed all
open procedures, and three surgeons with extensive experience in robot-assisted pelvic surgery performed the robotic procedures. All the
surgeons had completed a urologic oncology
fellowship and had at least 10 years of operative
experience after completion of the fellowship.
The primary outcome was the rate of complications of grade 2 to 5 within 90 days after surgery, on the basis of a five-grade Clavien system
(with grades ranging from 1 to 5, and higher
grades indicating greater severity).4

Table 1. Outcomes after Radical Cystectomy in the Intention-to-Treat Analysis.*

Robot-Assisted Surgery
(N=60)

Open Surgery
(N=58)

Grade 25

37 (62)

38 (66)

4 (21 to 13)

0.66

Grade 35

13 (22)

12 (21)

1 (14 to 16)

0.90

45682

32977

127 (98 to 156)

<0.001

83

85

0 (2 to 1)

0.53

Variable

Difference
(95% CI)

P Value

Complication no. of patients (%)

Operating-room time min

Length of stay in hospital days

* Plusminus values are means SD. Differences between percentages are measured in percentage points. Complications
were assessed according to a five-grade modified Clavien system (with grades ranging from 1 to 5 and higher grades
indicating greater severity).4 CI denotes confidence interval.

n engl j med 371;4nejm.orgjuly 24, 2014

The New England Journal of Medicine

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Copyright 2014 Massachusetts Medical Society. All rights reserved.

389

corrections

Overall, 118 patients were randomly assigned

to open radical cystectomy (58 patients) or robotassisted radical cystectomy (60). A total of 4 patients assigned to robot-assisted surgery declined
the randomized assignment and underwent open
surgery. Enrollment was closed early after a
mandated interim analysis showed outcomes
that met predefined criteria for futility. Baseline
characteristics were similar in the two groups
(Table 1 in the Supplementary Appendix, available at NEJM.org). On the basis of an intentionto-treat analysis, we found that 37 patients
(62%) who underwent robot-assisted surgery and
38 (66%) who underwent open surgery had a complication of grade 2 to 5 (difference, 4 percentage points; 95% confidence interval, 21 to 13;
P=0.66) (Table 1). High-grade (grade 3 to 5)
complications occurred in 22% and 21% of the
patients, respectively (P=0.90). Intraoperative
blood loss was less in the group that underwent
robot-assisted surgery (mean difference, 159 cm3),
but the length of surgery was significantly
shorter in the open-surgery group (mean difference, 127 minutes; P<0.001). The mean length of
stay in the hospital was 8 days in each group
(P=0.53).
This randomized trial showed similar rates of
perioperative complications and lengths of hospital stay among patients who underwent robotassisted surgery and those who underwent open
surgery. The confidence intervals argue against
a large benefit of robotic techniques with respect to perioperative morbidity. Because the
trial was performed by experienced surgeons at
a single, high-volume referral center, the results
may not be generalizable to all clinical settings.
Nonetheless, these results highlight the need for
randomized trials to inform the benefits and
risks of new surgical technologies before widespread implementation.
Bernard H. Bochner, M.D.
Daniel D. Sjoberg, M.A.
Vincent P. Laudone, M.D.
Memorial Sloan Kettering Cancer Center
New York, NY

for the Memorial Sloan Kettering Cancer Center

Bladder Cancer Surgical Trials Group
A list of the members of the Memorial Sloan Kettering Cancer
Center Bladder Cancer Surgical Trials Group is provided in the
Supplementary Appendix, available at NEJM.org.
Supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan Kettering Cancer Center, Pin
Down Bladder Cancer, and the Michael A. and Zena Wiener Research and Therapeutics Program in Bladder Cancer.

390

1. Chavan S, Bray F, Lortet-Tieulent J, Goodman M, Jemal A.

International variations in bladder cancer incidence and mortality. Eur Urol 2014;66:59-73.
2. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012.
CA Cancer J Clin 2012;62:10-29.
3. Johar RS, Hayn MH, Stegemann AP, et al. Complications
after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Eur Urol 2013;64:52-7.
4. Shabsigh A, Korets R, Vora KC, et al. Defining early morbidity of radical cystectomy for patients with bladder cancer using a
standardized reporting methodology. Eur Urol 2009;55:164-76.
DOI: 10.1056/NEJMc1405213
Correspondence Copyright 2014 Massachusetts Medical Society.

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corrections
A Randomized Trial of Epidural Glucocorticoid Injections for
Spinal Stenosis (July 3, 2014;371:11-21). In the Discussion, the
first sentence of the third paragraph (page 19) should have
begun, In analyses adjusted for the duration of pain (which
was longer in the glucocorticoid group)..., rather than
...(which was longer in the lidocaine-alone group)....
The article is correct at NEJM.org.
Risk of Pediatric Celiac Disease According to HLA Haplotype and
Country (July 3, 2014;371:42-9). In the Abstract (page 42), the
fourth sentence of Results (beginning, The risks . . .) should
have ended, . . . and 26% and 11%, respectively, among those
with two copies (DR3DQ2 homozygosity), rather than . . . and
26% and 12% . . . . The article is correct at NEJM.org.

n engl j med 371;4nejm.orgjuly 24, 2014

The New England Journal of Medicine

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