Robotic Radical Cystectomy—Is the Diversion the Achilles' Heel?

3
Opposing Views Robotic Radical CystectomydIs the Diversion the Achilles’ Heel? YES OPEN radical cystectomy (RC) is the standard treatment for invasive bladder cancer. Although a morbid procedure, it does save lives and quality of surgery is critical to its success. Most of the morbidity is related to the obligatory urinary diversion (UD). Robotic radical cystectomy (RRC) has recently been advocated, with claims of fewer complications, faster recovery and functional out- comes similar to those of RC. 1 Such claims are based on retrospective analysis of collected cases fraught with selection bias, missing data, short followup and unquantified variables. It remains to be seen whether RRC provides results comparable to RC in unselected patients. After RRC, urinary diversion may be done as an open procedure (though small incisions) or entirely within the abdomen using the robot. In a random- ized trial Bochner et al reported no advantage of RRC and extracorporeal UD over conventional RC in 90-day complications, recovery times or surgical outcomes, 2 suggesting that any real benefit of RRC requires intracorporeal robotic urinary diversion, whether as an ileal stoma or orthotopic neobladder. Despite the potential advantages of RRC, such as decreased blood loss, quicker bowel recovery and decreased analgesic requirements, it is associated with longer operative time, similar length of stay, steeper learning curve, especially for intracorporeal UD, and higher costs. The main drawback of RRC is that the long-term functional performance of robot-constructed diversion remains unknown. Compromised technique of extracorporeal and intracorporeal robotic orthotopic neobladder Experience with open orthotopic neobladder (ONB) has shown that several principles are critical to ensure successful functional outcomes. Detubulari- zation, cross (double) folding and, to a lesser extent, a spherical shape result in a larger radius, greater volume and ultimately lower pressure. 3 Almost all robotic reservoirs are constructed from short (40 cm) ileal segments, have significant undetubularized portions and are only U-shaped. 4e7 As a result, they have a small radius of 2.4 cm, geometric capacity of just 180 to 271 cc and pressure twice as high compared to a standard open ONB with a radius of 4.8 cm and geometric capacity as high as 1,085 cc. 8 If the UD is performed extracorporeally, the devascularized ureters must be left long and an increased stenosis rate is to be expected. Patients expect results obtained with a novel technique to be at least as good as those obtained with an established technique. Decreased use of continent UD It is also a concern that in most RRC series less than 20% of patients undergo orthotopic reconstruction. Given such a highly selected group of patients, one would expect this technique to be performed in at least 50% to 60% of patients. Inferior functional outcomes of robotic ONB The ultimate success with ONB depends on achievement of continence. Daytime continence is determined only by the condition of the external sphincter, irrespective of the type of reservoir and whether it was constructed from a tubularized or detubularized intestinal segment. Nighttime conti- nence depends on the functionality of the reservoir. 9 Daytime and nighttime urinary incontinence has been reported in 7% to 13% and 14% to 43% of patients with an open ONB, respectively. 9 Regret- tably, robotic series define continence differently (allowing diapers in continent patients) 6 and report quality of life metrics instead of urinary inconti- nence data. Using standard definitions, Canda et al reported as expected daytime continence in 73% of patients following robotic ONB but just 20% of the patients were dry at night and 53% were totally incontinent. 5 Inappropriate outcome reporting Robotic surgeons claim to replicate open surgical principles and outcomes with 90-day complication rates of 70% and Clavien 3 to 5 complication rates of 15% to 50% in highly selected groups of pa- tients. 5,6,10 However, they disregard the fact that these corresponding rates after 113 cases of open ONB were as low as 46% and 4%. 8 0022-5347/14/1926-1601/0 THE JOURNAL OF UROLOGY ® © 2014 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH,INC. http://dx.doi.org/10.1016/j.juro.2014.09.042 Vol. 192, 1601-1603, December 2014 Printed in U.S.A. www.jurology.com j 1601

Transcript of Robotic Radical Cystectomy—Is the Diversion the Achilles' Heel?

Page 1: Robotic Radical Cystectomy—Is the Diversion the Achilles' Heel?

Opposing Views

Robotic Radical CystectomydIs the Diversion the Achilles’ Heel?

YES just 180 to 271 cc and pressure twice as high

OPEN radical cystectomy (RC) is the standardtreatment for invasive bladder cancer. Although amorbid procedure, it does save lives and qualityof surgery is critical to its success. Most of themorbidity is related to the obligatory urinarydiversion (UD). Robotic radical cystectomy (RRC)has recently been advocated, with claims of fewercomplications, faster recovery and functional out-comes similar to those of RC.1 Such claims are basedon retrospective analysis of collected cases fraughtwith selection bias, missing data, short followupand unquantified variables. It remains to be seenwhether RRC provides results comparable to RC inunselected patients.

After RRC, urinary diversion may be done as anopen procedure (though small incisions) or entirelywithin the abdomen using the robot. In a random-ized trial Bochner et al reported no advantage ofRRC and extracorporeal UD over conventional RCin 90-day complications, recovery times or surgicaloutcomes,2 suggesting that any real benefit of RRCrequires intracorporeal robotic urinary diversion,whether as an ileal stoma or orthotopic neobladder.

Despite the potential advantages of RRC, such asdecreased blood loss, quicker bowel recovery anddecreased analgesic requirements, it is associatedwith longer operative time, similar length of stay,steeper learning curve, especially for intracorporealUD, and higher costs. The main drawback of RRCis that the long-term functional performance ofrobot-constructed diversion remains unknown.

Compromised technique of extracorporeal andintracorporeal robotic orthotopic neobladderExperience with open orthotopic neobladder (ONB)has shown that several principles are critical toensure successful functional outcomes. Detubulari-zation, cross (double) folding and, to a lesser extent,a spherical shape result in a larger radius, greatervolume and ultimately lower pressure.3 Almost allrobotic reservoirs are constructed from short (40 cm)ileal segments, have significant undetubularizedportions and are only U-shaped.4e7 As a result, theyhave a small radius of 2.4 cm, geometric capacity of

0022-5347/14/1926-1601/0

THE JOURNAL OF UROLOGY®

© 2014 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC.

compared to a standard open ONB with a radius of4.8 cm and geometric capacity as high as 1,085 cc.8

If the UD is performed extracorporeally, thedevascularized ureters must be left long and anincreased stenosis rate is to be expected. Patientsexpect results obtained with a novel technique tobe at least as good as those obtained with anestablished technique.

Decreased use of continent UDIt is also a concern that in most RRC series less than20% of patients undergo orthotopic reconstruction.Given such a highly selected group of patients, onewould expect this technique to be performed in atleast 50% to 60% of patients.

Inferior functional outcomes of robotic ONBThe ultimate success with ONB depends onachievement of continence. Daytime continence isdetermined only by the condition of the externalsphincter, irrespective of the type of reservoir andwhether it was constructed from a tubularized ordetubularized intestinal segment. Nighttime conti-nence depends on the functionality of the reservoir.9

Daytime and nighttime urinary incontinence hasbeen reported in 7% to 13% and 14% to 43% ofpatients with an open ONB, respectively.9 Regret-tably, robotic series define continence differently(allowing diapers in continent patients)6 and reportquality of life metrics instead of urinary inconti-nence data. Using standard definitions, Canda et alreported as expected daytime continence in 73% ofpatients following robotic ONB but just 20% of thepatients were dry at night and 53% were totallyincontinent.5

Inappropriate outcome reportingRobotic surgeons claim to replicate open surgicalprinciples and outcomes with 90-day complicationrates of 70% and Clavien 3 to 5 complication ratesof 15% to 50% in highly selected groups of pa-tients.5,6,10 However, they disregard the fact thatthese corresponding rates after 113 cases of openONB were as low as 46% and 4%.8

http://dx.doi.org/10.1016/j.juro.2014.09.042

Vol. 192, 1601-1603, December 2014

Printed in U.S.A.

www.jurology.com j 1601

Page 2: Robotic Radical Cystectomy—Is the Diversion the Achilles' Heel?

1602 OPPOSING VIEWS

ConclusionsWhen one must resort to a simple U-shaped reser-voir rather than the standard (and more compli-cated) intracorporeal ONB, urinary function isbound to suffer. However, optimum function is moreimportant than a smaller scar or time to first flatus.Patients with bladder cancer must be assured thatthey will get the best possible functional results,which may seriously impact future quality of life.

Open ONB remains the gold standard for conti-nent diversion following RC. Robotic intracorporealONB remains investigational and must not com-promise surgical principles optimizing survival. Ithas not been shown whether RRC and robotic UDprovide survival, local control or urinary functioncomparable to that of RC. Furthermore, functionalas well as oncologic and quality of life outcomes ofRRC and robotic UD must be confirmed in ran-domized and prospective controlled cohort studies.

Richard E. HautmannUniversity of Ulm

Ulm, Germany

and

Harry W. HerrDepartment of Urology

Memorial Sloan Kettering Cancer Center

New York, New York

NO

Since the initial description of the technique ofrobotic radical cystectomy by Menon et al in 2003,11

a number of authors have published their outcomes,mostly in retrospective case series. To date, only3 randomized studies comparing RRC with openradical cystectomy (ORC), the reference standard,have been published.2,12,13 Current data indicatethat RRC is not inferior to ORC in terms of onco-logical parameters as well as morbidity. Decreasedblood loss is a clear benefit of RRC.2,12,13 There alsoappears to be lower narcotic requirement and atrend towards shorter length of stay (LOS) withRRC.12,13 Due to the cost of the robot, disposablesand annual maintenance contract, direct costs arehigher for RRC. However, a recent population basedstudy indicated that overall cost differences be-tween RRC and ORC are not significant for highvolume surgeons (7 or more surgeries a year) andhospitals (19 or more surgeries ar year).1 It is esti-mated that if the LOS were reduced to 7 days, whichis possible with enhanced recovery pathways, thenRRC would be at a cost advantage with operatingroom time 380 minutes or less, which is achievableat high volume centers.1

Accordingly, RRC use has increased 21-fold from0.6% in 2004 to 12.8% in 2010.1 However, most of

these cases have been done using a hybrid tech-nique, wherein a robotic approach is used for theextirpative part of the operation followed by anextracorporeal urinary diversion. Even with thishybrid approach, the aforementioned benefits onoutcomes have been repeatedly demonstrated,suggesting improved outcomes at a similar cost.

Thus, there seems to be a benefit with a roboticapproach to the extirpative portion of the surgery,even with open diversion. Could these benefits befurther extended with the use of an intracorporealdiversion? As the adoption of RRC has grownexponentially, there has been increasing interest inusing an intracorporeal, purely robotic, approach tothe diversion.4,14e16 Given the advantages of therobotic platform for reconstruction, in terms ofwristed instrumentation and 3-D visualization,intracorporeal diversion would seem to be a naturalextension of robotics in cystectomy.

In a recent report on the International RoboticCystectomy Consortium database (a multi-institutional database of almost 1,000 patients whohave undergone RRC at 1 of 18 institutions) Ahmedet al evaluated the outcomes of patients undergoingRRC with an extracorporeal diversion vs an intra-corporeal diversion.17 The intracorporeal group hada lower rate of overall complications (p ¼ 0.05),gastrointestinal complications (p <0.001), and30 and 90-day readmission rates (p <0.001 andp¼ 0.016, respectively). There were no differences inreoperation rates or operating time. These resultsindicate that intracorporeal diversion may furtheradd to the benefits of a robotic approach and suggestfurther exploration of this promising technique.

All randomized studies to date comparing RRCwith ORC have included open diversion.2,12,13 Theextirpative part of the operation is associated withthe most blood loss, and in all 3 randomized trialsblood loss was significantly decreased with RRC.Thus, robotic surgery has demonstrated a clearbenefit in the portion of the operation for which itwas used. Most of the 90-day complications from RCare related to the bowel work and diversion. Noneof the 3 randomized trials used robotics for thediversion.

The largest of these randomized studies usedcomplication rates within 90 days after RRC or ORCas the primary outcome.2 In the robotic portion ofthe operation a benefit in terms of blood loss wasnoticed but there was no difference in the 90-daycomplication rate. This is not surprising as patientsin both cohorts underwent the same open diversionperformed by the same surgeons. Ideally, a properlydesigned trial shouldminimize all other confoundingvariables except technique, ie robotic or open.

A trial of open vs robotic cystectomy in 2010using the same surgeons equally skilled in both

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OPPOSING VIEWS 1603

techniques revealed no difference in oncologicoutcomes but an advantage favoring robotics withregard to blood loss, recovery time and complica-tions.12 A secondary analysis of this trial alsorevealed no difference in overall cost of care. Similarfindings were found in another randomized study,again demonstrating benefits with the roboticextirpative approach and extracorporeal diversion.13

Going forward, to truly assess a difference betweenRRC and ORC we need an unbiased, adequatelypowered, prospective randomized trial comparingpure RRC with robotic intracorporeal diversion toORC performed by surgeons with demonstratedexpertise in both operations.

The recent debate about the adoption of innova-tive approaches such as robotics reminds us of thestory of Dr. Ignaz Semmelweis, who practiced at theuniversity hospital in Vienna in the mid 19th cen-tury. He discovered that handwashing and otherantiseptic techniques could dramatically reduce theincidence of sometimes fatal puerperal infections.These observations conflicted with the establishedscientific opinions of the time and were forcefully

rejected by the medical community. He was publiclyhumiliated and socially ostracized, which resultedin his loss of employment, severe depression andalcoholism. He was eventually committed to aViennese insane asylum where he died due to severephysical beatings. Interestingly, a few decades laterhis findings were validated when the germ theory ofdisease was developed.

Today, the “Semmelweis effect” is a metaphor forthe reflex-like tendency to reject new knowledgebecause it contradicts established norms, beliefs orparadigms. These lessons implore us to not ignoreemerging evidence and to embracemedical advances,particularly when such innovation provides poten-tially improved outcomes and value for our patients.

Raj S. PruthiUniversity of North Carolina at Chapel Hill

Chapel Hill, North Carolina

and

Monish AronUniversity of Southern California

Los Angeles, California

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