Early Complication Rates in a Single-Surgeon Series of 2500 Robotic-Assisted Radical Prostatectomies: Report Applying a Standardized Grading System

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Platinum Priority – Prostate CancerEditorial by Manfred P. Wirth and Michael Froehner on pp. 953–954 of this issue

Early Complication Rates in a Single-Surgeon Series of 2500

Robotic-Assisted Radical Prostatectomies: Report Applying a

Standardized Grading System

Rafael F. Coelho a,b,c, Kenneth J. Palmer a,b, Bernardo Rocco a,b,d, Ravendra R. Moniz e,Sanket Chauhan a,b, Marcelo A. Orvieto a,b, Geoff Coughlin a,b, Vipul R. Patel a,b,*

a Global Robotics Institute, Florida Hospital Celebration Health, Celebration, Florida, USAb University of Central Florida School of Medicine, Orlando, Florida, USAc Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Divisao de Urologia, Sao Paulo, Brazild Divisione di Urologia, Istituto Europeo di Oncologia, Milan, Italye Division of Urology, Faculty of Medical Sciences Santa Casa, Sao Paulo, Brazil

E U R O P E A N U R O L O G Y 5 7 ( 2 0 1 0 ) 9 4 5 – 9 5 2

ava i lable at www.sciencedirect .com

journal homepage: www.europeanurology.com

Article info

Article history:

Received 12 December 2009Accepted February 3, 2010Published online ahead ofprint on February 13, 2010

Keywords:

Prostatectomy

Complications

Robotics

Prostatic neoplasm

Abstract

Background: Perioperative complications following robotic-assisted radical prostatectomy(RARP) have been previously reported in recent series. Few studies, however, have usedstandardized systems to classify surgical complications, and that inconsistency has hampered

accurate comparisons between different series or surgical approaches.Objective: To assess trends in the incidence and to classify perioperative surgical complicationsfollowing RARP in 2500 consecutive patients.Design, setting, and participants: We analyzed 2500 patients who underwent RARP for treat-ment of clinically localized prostate cancer (PCa) from August 2002 to February 2009. Data wereprospectively collected in a customized database and retrospectively analyzed.Intervention: All patients underwent RARP performed by a single surgeon.Measurements: The data were collected prospectively in a customized database. Complica-

tions were classified using the Clavien grading system. To evaluate trends regarding complica-tions and radiologic anastomotic leaks, we compared eight groups of 300 patients each,categorized according the surgeon’s experience (number of cases).Results and limitations: Our median operative time was 90 min (interquartile range [IQR]: 75–100 min). The median estimated blood loss was 100 ml (IQR:100–150 ml). Our conversion ratewas 0.08%, comprising two procedures converted to standard laparoscopy due to robot malfunc-

tion. One hundred and forty complications were observed in 127 patients (5.08%). The followingpercentages of patients presented graded complications: grade 1, 2.24%; grade 2, 1.8%; grade 3a,0.08%; grade 3b, 0.48%; grade 4a, 0.40%. There were no cases of multiple organ dysfunction ordeath (grades 4b and 5). There were significant decreases in the overall complication rates( p = 0.0034) and in the number of anastomotic leaks ( p < 0.001) as the surgeon’s experience

increased.Conclusions: RARP is a safe option for treatment of clinically localized PCa, presenting lowcomplication rates in experienced hands. Although the robotic system provides the surgeon

andrat

with enhanced visionvolume; complication

increased.

# 2010 European Assoc

* Corresponding author. GloTel. +1 407 303 46 73; FaxE-mail address: vipul.patel.

0302-2838/$ – see back matter # 2010 European Association of Urology. Publis

dexterity, proficiency is only accomplished with consistent surgicales demonstrated a tendency to decrease as the surgeon’s experience

iation of Urology. Published by Elsevier B.V. All rights reserved.

bal Robotics Institute, 410 Celebration Place, Celebration, FL 34747 USA.: +1 407 303 46 [email protected] (V.R. Patel).

hed by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2010.02.001

Page 2

E U R O P E A N U R O L O G Y 5 7 ( 2 0 1 0 ) 9 4 5 – 9 5 2946

1. Introduction

Data from the Surveillance, Epidemiology and End Results

registry indicate that the incidence of prostate cancer (PCa)

in men under 50 has risen steadily over the past 10 yr, with

an annual percent increase of 9.5% [1]. In addition, with the

widespread diffusion of prostate-specific antigen (PSA)

testing, PCa is frequently diagnosed in younger and

healthier men with organ-confined disease. Consequently,

patients desire to undergo definitive treatment with short

recovery time and low complication rates while maintain-

ing their baseline quality of life.

Since Reiner and Walsh [2] first introduced the anatomic

nerve-sparing technique for radical retropubic prostatecto-

my (RRP), this procedure has become the gold standard and

the most widespread treatment for clinically localized PCa,

providing excellent cancer control in most patients with

clinically localized disease [3]. However, although several

modifications have been added to the original technique

and most urologic surgeons are now familiar with the

procedure, RRP still has an inherent morbidity.

In an effort to further decrease the morbidity of RRP, a

laparoscopic minimally invasivesurgicalapproachtotreating

PCa was first described by Schuessler and colleagues [4] in

1997. Although cancer cure with laparoscopic radical

prostatectomy (LRP) was deemed comparable to open

surgery, the technical demands of the surgery and the

protracted learning curve has prevented the widespread

adoption of LRP by most urologic surgeons. The da Vinci

Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) has

been introduced to the field of urologic surgery and, with

the advantages of three-dimensional vision, 7 degrees of

freedom, and magnification,hasraised newhopes ofreducing

both the morbidity and the learning curve of minimally

invasive prostatectomy [5]. But as expected, the introduction

of any innovative technology or surgical procedure is

associated with an initial learning curve and with the

potential of eliciting new risks and surgical complications [6].

Perioperative complications following robotic-assisted

radical prostatectomy (RARP) have been previously

reported in some recent series. Few studies, however, have

used standardized systems to classify surgical complica-

tions, and that inconsistency has hampered accurate

comparisons between different series or surgical

Table 1 – Classification of surgical complications: Clavien grading syst

Grade*

1 Any deviation from the normal postoperative course with

Allowed therapeutic regimens are drugs as antiemetics, a

also includes wound infections opened at the bedside.

2 Requiring pharmacologic treatment with drugs other tha

Blood transfusions and total parenteral nutrition are also

3 Complications requiring surgical, endoscopic, or radiolog

4 Any life-threatening complication requiring intermediate

multiple-organ dysfunction).

5 Death of a patient.

* If the patient suffers from a complication at the time of discharge, the suffix ‘‘d

indicates the need for follow-up to fully evaluate the complication.

approaches. Based on these limitations, Clavien and

colleagues proposed a grading system for surgical compli-

cations in 1992 and modified it in 2004 [7]. The Clavien

grading system is a simple, objective, and reproducible

approach for comprehensive surgical outcomes assessment

and has been applied more frequently in recent publications

reporting complications after RRP, LRP, and RARP.

In this study we analyzed early surgical complications in

a single-surgeon series of 2500 consecutive RARPs. Com-

plications were classified according to the modified Clavien

grading system, and trends in the incidence of morbidities

according to the surgeon’s experience were analyzed.

2. Materials and methods

We analyzed 2500 consecutive patients who underwent RARP for

treatment of clinically localized PCa. All of the procedures were

performed by a single surgeon (VRP) from August 2002 to February

2009. After institutional review board approval, data were prospectively

collected in a customized database and retrospectively analyzed.

Complications were classified in our database according to the modified

Clavien grading system (Table 1) [7].

2.1. Operative technique

All patients underwent a six-port transperitoneal technique, as described

previously by the authors [8]. An anterior approach was adopted by

dissecting the retzius space and ligating the dorsal venous complex (DVC).

Recently, we have adopted a periurethral suspension stitch [9] after the

ligation of the DVC. This step was followed by bladder neck dissection and

athermal mobilization of the seminal vesicles. The nerve sparing was

modified and performed athermally with an early retrograde release of the

neurovascular bundle. Bilateral pelvic lymph node dissection (PLND) was

performed in patients classified as intermediate or high risk, according to

the D’Amico classification [10]. A modified posterior reconstruction of the

rhabdosphincter [11] was then performed prior to vesicourethral

anastomosis in the last 1500 patients of our series. The anastomosis

was performed using a continuous running suture with two 3-0 monocryl

sutures tied together. A 18-Fr Foley catheter was inserted. The specimen

was then removed through the primary trocar incision, and a Jackson-Pratt

(JP) drain was positioned in the pelvic gutter.

2.2. Perioperative management

A single intravenous dose of a first-generation cephalosporin and 5000 U

of low-molecular-weight heparin (5000 IU subcutaneously 2 h prior to

em [6]

Description

no specific treatment required.

ntipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade

n such allowed for grade 1 complications.

included.

ic intervention (grade 3b if under general anesthesia and grade 3a if not).

or intensive care (grade 4a for single-organ dysfunction and grade 4b for

’’ (for disability) is added to the respective grade of complication. This label

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Table 2 – Preoperative patient characteristics

Patient characteristics

Age, yr, median (IQR) 61 (55–66)

BMI, kg/m2, median (IQR) 28 (26–31)

PSA level, ng/ml, median (IQR) 4.9 (3.8–6.7)

Prostate weight, g, median (IQR) 48 (40–59)

AUA-SS, median (IQR) 7 (3–12)

Biopsy Gleason score, %

�6 64

7 28.5

�8 7.5

Pathologic stage, %

pT2 75

pT3 24.3

pT4 0.7

Positive surgical margin rates, %

Overall 10.6

pT2 5

pT3 27.5

Pathologic Gleason score, %

�6 42

7 51.8

�8 6.2

AA-SS = American Urological Association symptom score; BMI = body mass

index; IQR = interquartile range; PSA = prostate-specific antigen.

E U R O P E A N U R O L O G Y 5 7 ( 2 0 1 0 ) 9 4 5 – 9 5 2 947

surgery and then every 12 h until hospital discharge) were administered

preoperatively.

Patients were allowed to drink and eat liberally in the postoperative

period and were discharged on postoperative day 1 once they were able

to ambulate and tolerate diet with minimal discomfort. Cystograms

were performed routinely prior to catheter removal, and in the event of

identifying a leak, the catheter was left in place for an additional 7 d.

Urinary retention was managed similarly with prolonged catheter

drainage until the patient was able to completely empty the bladder.

2.3. Data collection

Complications occurring during the surgical procedure or within 30 d

after surgery were analyzed (early complications). We examined 79%

(1975 of 2500) of our patients at our office 6 wk postoperatively;

complications that developed during the first postoperative month were

assessed and recorded. The 525 patients who were not evaluated at our

office were contacted via phone interview (32%), mail (3%), or e-mail

(65%). Initially, standardized questionnaires evaluating possible un-

scheduled visits to the primary urologist’s office or hospital admissions

were delivered by e-mail at 6–8 wk after surgery. Those patients who did

not reply were then contact by phone or by mail, applying the same

questionnaires. The phone calls were performed by a third party not

involved in direct patient care.

2.4. Definitions of complications

Perioperative blood transfusion was usually indicated for symptomatic

patients and/or hemoglobin levels �7 g/l. For intermediate hemoglobin

concentrations (ie, 7–10 g/dl), blood transfusion was indicated in case of

potential or actual ongoing bleeding or in the presence of risk factors for

complications secondary to inadequate oxygenation (ie, cardiac ische-

mic disease).

Ileus was defined as postoperative nausea, vomiting, and/or

abdominal distension requiring hospitalization time>2 d in the absence

of mechanical bowel obstruction.

Symptomatic lymphocele was defined as a pelvic fluid collection

(especially along the iliac vessels) in patients who underwent PLND and

associated with pelvic pain or pressure, unilateral leg edema and/or pain,

hydronephrosis, deep vein thrombosis (DVT), or infection/sepsis.

2.5. Statistical analysis

Continuous parametric variables were reported as the mean value plus

or minus standard deviation. Continuous nonparametric variables were

presented as the median values and interquartile range (IQR).

To evaluate trends regarding complications and anastomotic leaks,

we compared eight groups of 300 patients each, classified according the

surgeon’s experience (number of cases). The groups were compared

using the x2 test for linear trend. All statistical analyses were performed

using StatsDirect v.2.7.2 statistical software (StatsDirect Ltd., Cheshire,

UK). Statistical significance was defined as p < 0.05.

3. Results

3.1. Early surgical outcomes

Patient characteristics are presented in Table 2.

The median follow-up of our cohort was of 25 mo

(IQR:10–35 mo). Median operative time was 90 min (IQR:

75–100 min), and the median estimated blood loss was

100 ml (IQR:100–150 ml). Bilateral PLND was performed in

44.5% of our patients. Our conversion rate was 0.08%,

comprising two procedures converted to standard laparos-

copy due to robot malfunction. No cases were converted to

open surgery. In our series, 95% of patients were discharged

home on postoperative day 1, and only 0.6% of the patients

were hospitalized for >3 d. The median duration of in-

hospital stay was 1 d. Finally, the median catheterization

time was 5 d (IQR: 4–6 d).

3.2. Description of complications

We observed 140 complications in 127 patients (5.08%).

Intraoperative complications included two rectal injuries,

which occurred in the 8th and 15th patients. Both injuries

were recognized intraoperatively and closed primarily

using a two-layer technique. These patients had a full

mechanical bowel preparation and antibiotic prophylaxis

prior to surgery. Both patients were discharged from the

hospital on postoperative day 2. After surgery, neither

patient had adverse effects from the injuries.

Classification of the complications according the Clavien

grading system is shown in Table 3. There was no case of

multiple-organ dysfunction or death (grades 4b and 5).

Minor complications (grades 1 and 2) constituted 80.8% of

all complications. The incidence of severe complications

(grade �3) was <1% (0.96%; Table 4).

The two most common grade 1 complications were

anastomotic leaks (1.4%), detected on cystogram, and

urinary retention (0.52%). The third most common grade

1 complication was symptomatic lymphocele (0.36%).

Clinical manifestations of lymphocele included pelvic

pressure in four cases, abdominal distension in three cases,

leg pain or weakness in one case, and costovertebral

tenderness in one case. Of these patients, only one required

computed tomography (CT)–guided drainage for treatment

Page 4

Table 3 – Complications in a cohort of 2500 robotic-assisted radical prostatectomies

Complications No. of occurrences* (n = 127) Clavien grade Incidence, %

Intraoperative

Rectal injury 2 – 0.08

Perioperative (before hospital discharge)

Blood transfusion 12 2 0.48

Myocardial infarction 5 4a 0.20

Pulmonary embolus 5 4a 0.20

Ileus 18 2 0.72

Deep vein thrombosis 3 2 0.12

Wound dehiscence 5 2, 3b 0.2

Bowel herniation through trocar site 1 3b 0.04

Bowel obstruction 2 2, 3b 0.08

Reoperation, bleeding 2 3b 0.08

Cholecystitis 1 3b 0.04

Postoperative (after hospital discharge)

Anastomotic leakage 35 1d 1.40

Urinary retention 13 1d 0.52

Wound infection 14 2 0.56

Incisional hernia 3 3b 0.12

Bladder neck contracture 3 3b 0.12

Symptomatic lymphocele 9 1, 3a 0.36

Epididymitis 1 2 0.04

Meatal stenosis 1 3a 0.04

Urinary tract infection 4 2 0.16

Clip eroding through anastomosis 1 3a 0.04

Total 140 – –

* Patients who experienced multiple complications were counted more than once.

E U R O P E A N U R O L O G Y 5 7 ( 2 0 1 0 ) 9 4 5 – 9 5 2948

of an infected lymphocele. This last complication was

classified as grade 3a.

Prolonged ileus was the most common grade 2

complication (0.72%). These patients were managed with

maintenance of intravenous fluid and temporary restriction

of oral intake with resolution of the symptoms. Fourteen

patients (0.56%) presented with wound infection and were

managed with oral antibiotics and local wound care. Three

patients (0.12%) presented with DVT and were managed

with intravenous heparin followed by oral anticoagulation.

Four patients (0.16%) presented with urinary tract infection

after catheter removal and were managed with oral

antibiotics. One patient (0.04%) presented with acute

epididymitis and was treated with oral antibiotics with

resolution of the symptoms. The blood transfusion rate was

0.48% (12 patients).

Table 4 – Robotic-assisted radical prostatectomy complications:Clavien grading system

Claviengrade

No. ofpatients

Percentage ofpatients, %

Incidence, %

1 56 44.80 2.24

2 45 36 1.8

3a 2 1.6 0.08

3b 12 9.60 0.48

4a 10 8.00 0.40

4b 0 0 0

5 0 0 0

Total 125 100 –

1 + 2 101 80.8 4.04

3 + 4a 24 19.2 0.96

Grade 3a complications included one (0.04%) infected

lymphocele (as described previously); one (0.04%) meatal

stenosis, managed with meatal incision under local

anesthesia; and one (0.04%) Hemo-o-lok clip erosion into

vesicourethral anastomosis. This last patient presented

with dysuria and weak stream 3 mo after the procedure. The

clip was identified and removed cystoscopically.

Grade 3b complications included one patient (0.04%)

with wound dehiscence, one patient (0.04%) with bowel

herniation through a trocar site, one patient (0.04%) with

bowel obstruction, one patient (0.04%) with acute chole-

cystitis, three patients (0.12%) with incisional hernias, three

patients (0.12%) with bladder neck contractures, and two

patients (0.08%) with reoperations for pelvic bleeding. The

herniation through the trocar site involved the assistant

10–12-mm port. The patient presented to the emergency

room on postoperative day 4 with severe right-side

abdominal pain. A CT scan was performed and demonstrated

the bowel herniation. The patient underwent an exploratory

laparotomy with bowel resection followed by an uneventful

operative course thereafter. With regard to the incisional

hernias, all occurred through the camera port at 3–6 mo after

RARP and were repaired with mesh placement. Bladder

neck contractures were managed with internal urethrotomy,

with resolution of the symptoms in all cases without

additional procedures. Two patients presented postoperative

bleeding, manifested by abdominal distension, high blood

drainage output in the JP drain, and drop in hemoglobin

levels. One patient underwent laparoscopic reexploration

using the same port positions used during RARP, and the

other underwent open reexploration. Blood clots were

removed from the pelvic cavity, and no active bleeding

Page 5

Fig. 1 – Complication rates versus surgeon’s experience.

Fig. 2 – Anastomotic leakage rates versus surgeon’s experience.

E U R O P E A N U R O L O G Y 5 7 ( 2 0 1 0 ) 9 4 5 – 9 5 2 949

was found. Postoperative period was uneventful after

reoperation.

Ten patients (0.4%) had grade 4a complications. Five

patients (0.2%) presented with acute myocardial infarction at

1–4 d after surgery. These patients were initially monitored

in the intensive care unit and were managed with clinical

treatment. They were discharged home with no further

complications and no residual disability following treatment.

Five patients (0.2%) were diagnosed with pulmonary

embolus (PE) after RARP. They received intravenous heparin

and were discharged home with warfarin. No pulmonary

function limitation was reported after treatment.

3.3. Trends in complications and anastomotic leaks detected on

cystogram

There was a significant decrease in the overall complication

rates with the increase of the surgeon’s experience

( p = 0.0034; Fig. 1). In addition, there was a significant

downward trend in the number of anastomotic leaks

detected on cystogram as the surgeon’s experience in-

creased ( p < 0.001; Fig. 2).

4. Discussion

Direct comparisons among RRP, LRP, and RARP complica-

tion rates are difficult due to variations in the definition and

classification of complications in the series currently

published in the literature. Donat [12] recently analyzed

the quality of complication reporting in the urologic

literature. A total of 109 studies reporting outcomes after

urologic surgery were analyzed. Of the 36 studies reporting

complication severity, only 7 (19%) used a numeric grading

system; 29 studies (81%) used a ‘‘major versus minor’’

categorization but with 26 different definitions of ‘‘major’’

complications. Additional parameters were commonly

underreported, including complication definitions in 79%

of the studies, outpatient data in 63%, comorbidities in 59%,

and the duration of the reporting period in 56%. The author

concluded that the lack of universally accepted reporting

guidelines, definitions, and grading systems has made it

impossible to compare surgical morbidity and outcomes in

urologic oncology patients.

A uniform classification system for perioperative compli-

cations is crucial to allow precise comparisons among

different techniques, surgeons and institutions. The updated

Clavien grading system has been used more frequently in

recent publications reporting complications of RRP, LRP, and

RARP [13–17]. In this paper, we report one of the largest

series describing complications following RARP according to

the Clavien system. We observed 140 complications in 127

patients (5.08%). Grades 1 and 2 comprised >80% of the

complications, and no cases of multiple-organ dysfunction or

death were reported. The most common complications were

anastomotic leaks detected on cystogram and urinary

retention, managed only with prolonged urethral catheteri-

zation. We also observed a significant decrease in the overall

complication rates ( p = 0.0034) and in the number of

anastomotic leaks detected on cystogram ( p < 0.001) as

our experienced increased.

Similarly, Badani et al. [13] evaluated 2766 consecutive

RARPs and showed that grades 1 and 2 complications

comprised >95% of the total number of complications.

The overall complication rate was 12.2%. These authors,

however, did not find a statistically significant difference in

the number of anastomotic leakages detected on cystogram

in the first 200 patients (12%) compared with the last 200

patients (8.5%) of the series. Nevertheless, their study

comprised RARPs performed by three different surgeons

and, therefore, does not represent a single-surgeon learning

curve. More recently, we added the posterior reconstruction

of the rhabdosphincter [11] to our standard RARP tech-

nique, and this change might also have had a role in the

reduction of our anastomotic leakage rates [18]. Neverthe-

less, posterior reconstruction of the rhabdosphincter was

not performed in our first 1000 patients; therefore, the

significant decrease in the leakage rates from group 1

(patients 1–300) to group 2 (patients 301–600) in our series

cannot be attributed to this technical modification and is

probably related to the surgeon’s learning curve.

Page 6

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E U R O P E A N U R O L O G Y 5 7 ( 2 0 1 0 ) 9 4 5 – 9 5 2950

Similar complication rates were recently observed by

Murphy et al. [14] in 400 consecutive RARPs. Clavien grades

1 and 2 were the most common complications reported

(66.7% of the total number of complications). The overall

complication rate was 15.75% (63 patients). Novara et al.

[15] recently reported higher complication rates following

RARP in 415 consecutive cases. They observed 102

complications in 90 patients (21.6%). According to the

modified Clavien system, 41 patients (10%) had grade 1

complications, 37 (9%) had grade 2 complications, 11 (3%)

had grade 3 complications, and 1 (0.2%) had grade 4

complications. The authors pointed out that the higher

complication rates observed in their series could reflect

more rigorous reporting of the data than in the previous

studies. Nevertheless, on the multivariable analysis, the

number of cases performed ( p < 0.001) was an independent

predictor for complications of any grade and could justify

the higher complication rates compared to larger series and

more experienced surgeons. Likewise, our complication

rates decreased from 9.3% in the first 300 cases to 3.3% in the

last 300 cases of our series. Perioperative parameters and

the complication rates reported in current RARP series are

shown in Table 5 [13–15,19–28].

Complications were further minimized in our series by

implementing specific protocols. Our initial 100 patients

underwent a full mechanical bowel preparation with

antibiotics and the use of a rectal bougie. We now require

clear liquids and magnesium citrate the day before surgery

and a Fleet Enema the night before and the morning of

surgery. Thromboembolic venous events, including DVT

and PE, were also prevented with the use of subcutaneous

heparin, sequential compression devices placed preopera-

tively, and precocious ambulation. Incidences of DVT

(0.12%) and PE (0.20%) in our series were similar to those

reported in the literature [13–15]. Other complications such

as bowel herniation through trocar sites, wound eviscera-

tion, and incisional hernias were minimized in our series

with minor technical modifications. In the former case, the

herniation involved the assistant 10–12-mm trocar port on

the patient’s right flank. Since this case, we have closed the

12-mm assistant trocar with a Carter-Thomason device, and

no further complications related to this trocar site have

been reported. With regard to wound evisceration and

incisional hernias, all occurred through the camera port. We

initially performed a running fascial closure using nonab-

sorbable sutures at the camera port; currently, we close the

fascia using 2-0 vicryl interrupted suture, and no complica-

tions related to the camera port site have been observed

since implementing this technical modification.

Few series comparing complications after RRP, LRP, and

RARP are available and the results are conflicting. Hu et al.

[19] compared intraoperative and early postoperative

complications in 358 consecutive LRPs and 322 RARPs

and showed lower overall complication rates after RARP

(27.7% vs 14.6%). By contrast, Rozet et al. [22], in a matched-

pair analysis of 133 extraperitoneal RARPs and 133

extraperitoneal pure LRPs, reported a higher overall

complication rate after RARP (19.4% vs 9.1%, p = 0.01).

In turn, Ficarra et al. [29], in cumulative analysis of

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E U R O P E A N U R O L O G Y 5 7 ( 2 0 1 0 ) 9 4 5 – 9 5 2 951

comparative studies, showed similar complication rates

after RARP and LRP (risk ratio [RR]: 1.83; 95% confidence

interval [CI], 0.78–4.31; p = 0.16). With regard to the

comparison between RRP and RARP, similar complication

rates were reported in most of the available publications.

Krambeck et al. [27] recently reported comparable periop-

erative overall complication rates between RARP and RRP

(8.0% vs 4.8%, p = 0.064). Similarly, Nelson et al. [23] showed

equivalent rates of unscheduled visits (RRP 10% vs RARP

10%, p = 0.95) and readmissions (RRP 5% vs RARP 7%,

p = 0.12) due to complications for these two surgical

approaches. Finally, the cumulative analysis of comparative

studies performed by Ficarra et al. [29] showed only a

nonstatistically significant trend in favor of RARP (RR: 1.33;

95% CI, 0.64–2.74; p = 0.44).

The strengths of our study are the large number of

patients, the single-surgeon experience, the application of a

standardized classification system, and the evaluation of

the complication rates stratified by the number of previous

procedures. We believe our study provides a valuable

contribution for future comparisons among different RP

series and surgical approaches. Nevertheless, our study has

some limitations. Despite our strict follow-up, our compli-

cation rate is subject to underreporting due to the short

duration of in-hospital stay and to the ‘‘retrospective’’

evaluation of complications at the 6-wk follow-up visit.

Additionally, although patients who were not evaluated at

our office were followed via phone interview or e-mail, the

patients’ primary urologists were not contacted in all cases;

therefore, some minor complications might have been

underreported by the patients. Moreover, we analyzed early

complications after RARP performed by a single surgeon

with large surgical experience; hence, our results might not

be applicable to low-volume RARP centers. Finally, Martin

et al. [30] recently proposed a standardized method for

reporting surgical complications based on 10 strict criteria

(eg, methods of data collection, duration of follow-up,

presence of outpatient information, definitions of compli-

cations, mortality and morbidity rates, procedure-specific

complication, grading system, length of in-hospital stay,

analysis of risk factors). Our study does not fulfill all of the

Martin criteria because some of the potential predictive

factors for complications (Charlson Index, comorbidities,

Eastern Cooperative Oncology Group performance status)

are not consistently available in our database and an

accurate multivariate analysis of risk factors for complica-

tions was not possible.

5. Conclusions

RARP is a safe option for treatment of clinically localized

PCa, presenting low complication rates in experienced

hands. Although the robotic system provides the surgeon

with enhanced vision and dexterity, proficiency is only

accomplished with consistent surgical volume; complica-

tion rates demonstrated a tendency to decrease as the

surgeon’s experience increased. The use of standardized

classification systems to analyze surgical complications will

allow proper comparisons among different surgical tech-

niques, surgeons, and institutions.

Author contributions: Vipul R. Patel had full access to all the data in the

study and takes responsibility for the integrity of the data and the

accuracy of the data analysis.

Study concept and design: Coelho, Palmer, Rocco, Patel.

Acquisition of data: Palmer, Coelho, Moniz, Chauhan.

Analysis and interpretation of data: Coelho, Moniz.

Drafting of the manuscript: Coelho, Moniz.

Critical revision of the manuscript for important intellectual content: Patel,

Rocco.

Statistical analysis: Coelho.

Obtaining funding: None.

Administrative, technical, or material support: None.

Supervision: Patel.

Other (specify): None.

Financial disclosures: I certify that all conflicts of interest, including

specific financial interests and relationships and affiliations relevant to

the subject matter or materials discussed in the manuscript (eg,

employment/affiliation, grants or funding, consultancies, honoraria,

stock ownership or options, expert testimony, royalties, or patents filed,

received, or pending), are the following: None.

Funding/Support and role of the sponsor: None.

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