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Early Complication Rates in a Single-Surgeon Series of 2500 Robotic-Assisted Radical Prostatectomies: Report Applying a Standardized Grading System
EUROPEAN UROLOGY 57 (2010) 945–952
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Priority – Prostate Cancer Editorial 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, USA
b
University of Central Florida School of Medicine, Orlando, Florida, USA
c
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sa˜o Paulo, Divisa˜o de Urologia, Sa˜o Paulo, Brazil
d
Divisione di Urologia, Istituto Europeo di Oncologia, Milan, Italy
e
Division of Urology, Faculty of Medical Sciences Santa Casa, Sa˜o Paulo, Brazil
Article info
Abstract
Article history: Received 12 December 2009 Accepted February 3, 2010 Published online ahead of print on February 13, 2010
Background: Perioperative complications following robotic-assisted radical prostatectomy (RARP) have been previously reported in recent series. Few studies, however, have used standardized 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 complications following RARP in 2500 consecutive patients. Design, setting, and participants: We analyzed 2500 patients who underwent RARP for treatment of clinically localized prostate cancer (PCa) from August 2002 to February 2009. Data were prospectively 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. Complications were classified using the Clavien grading system. To evaluate trends regarding complications 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 rate was 0.08%, comprising two procedures converted to standard laparoscopy due to robot malfunction. One hundred and forty complications were observed in 127 patients (5.08%). The following percentages 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 or death (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 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; complication rates demonstrated a tendency to decrease as the surgeon’s experience increased.
Keywords: Prostatectomy Complications Robotics Prostatic neoplasm
# 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Global Robotics Institute, 410 Celebration Place, Celebration, FL 34747 USA. Tel. +1 407 303 46 73; Fax: +1 407 303 46 32. E-mail address: vipul.patel.md@flhosp.org (V.R. Patel). 0302-2838/$ – see back matter # 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
doi:10.1016/j.eururo.2010.02.001
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1.
EUROPEAN UROLOGY 57 (2010) 945–952
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 maintaining their baseline quality of life. Since Reiner and Walsh [2] first introduced the anatomic nerve-sparing technique for radical retropubic prostatectomy (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 invasive surgical approach to treating 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, has raised new hopes of reducing 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 complications, and that inconsistency has hampered accurate comparisons between different series or surgical
approaches. Based on these limitations, Clavien and colleagues proposed a grading system for surgical complications 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. Complications 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
Table 1 – Classification of surgical complications: Clavien grading system [6] Grade* 1
2 3 4 5 *
Description Any deviation from the normal postoperative course with no specific treatment required. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside. Requiring pharmacologic treatment with drugs other than such allowed for grade 1 complications. Blood transfusions and total parenteral nutrition are also included. Complications requiring surgical, endoscopic, or radiologic intervention (grade 3b if under general anesthesia and grade 3a if not). Any life-threatening complication requiring intermediate or intensive care (grade 4a for single-organ dysfunction and grade 4b for multiple-organ dysfunction). Death of a patient.
If the patient suffers from a complication at the time of discharge, the suffix ‘‘d’’ (for disability) is added to the respective grade of complication. This label indicates the need for follow-up to fully evaluate the complication.
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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 unscheduled 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 ischemic disease). Ileus was defined as postoperative nausea, vomiting, and/or
Table 2 – Preoperative patient characteristics Patient characteristics Age, yr, median (IQR) BMI, kg/m2, median (IQR) PSA level, ng/ml, median (IQR) Prostate weight, g, median (IQR) AUA-SS, median (IQR) Biopsy Gleason score, % 6 7 8 Pathologic stage, % pT2 pT3 pT4 Positive surgical margin rates, % Overall pT2 pT3 Pathologic Gleason score, % 6 7 8
61 (55–66) 28 (26–31) 4.9 (3.8–6.7) 48 (40–59) 7 (3–12) 64 28.5 7.5 75 24.3 0.7 10.6 5 27.5 42 51.8 6.2
AA-SS = American Urological Association symptom score; BMI = body mass index; IQR = interquartile range; PSA = prostate-specific antigen.
44.5% of our patients. Our conversion rate was 0.08%, comprising two procedures converted to standard laparoscopy 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 inhospital stay was 1 d. Finally, the median catheterization time was 5 d (IQR: 4–6 d).
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
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
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Table 3 – Complications in a cohort of 2500 robotic-assisted radical prostatectomies No. of occurrences* (n = 127)
Complications Intraoperative Rectal injury
2
*
Incidence, %
–
0.08
12 5 5 18 3 5 1 2 2 1
2 4a 4a 2 2 2, 3b 3b 2, 3b 3b 3b
0.48 0.20 0.20 0.72 0.12 0.2 0.04 0.08 0.08 0.04
35 13 14 3 3 9 1 1 4 1 140
1d 1d 2 3b 3b 1, 3a 2 3a 2 3a –
1.40 0.52 0.56 0.12 0.12 0.36 0.04 0.04 0.16 0.04 –
Perioperative (before hospital discharge) Blood transfusion Myocardial infarction Pulmonary embolus Ileus Deep vein thrombosis Wound dehiscence Bowel herniation through trocar site Bowel obstruction Reoperation, bleeding Cholecystitis Postoperative (after hospital discharge) Anastomotic leakage Urinary retention Wound infection Incisional hernia Bladder neck contracture Symptomatic lymphocele Epididymitis Meatal stenosis Urinary tract infection Clip eroding through anastomosis Total
Clavien grade
Patients who experienced multiple complications were counted more than once.
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 Clavien grade 1 2 3a 3b 4a 4b 5 Total 1+2 3 + 4a
No. of patients
Percentage of patients, %
56 45 2 12 10 0 0 125 101 24
44.80 36 1.6 9.60 8.00 0 0 100 80.8 19.2
Incidence, %
2.24 1.8 0.08 0.48 0.40 0 0 – 4.04 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 cholecystitis, 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
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Fig. 2 – Anastomotic leakage rates versus surgeon’s experience. Fig. 1 – Complication rates versus surgeon’s experience.
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 increased ( p < 0.001; Fig. 2). 4.
Discussion
Direct comparisons among RRP, LRP, and RARP complication 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 complications 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 catheterization. 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 technique, and this change might also have had a role in the reduction of our anastomotic leakage rates [18]. Nevertheless, 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.
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1.8 NA 0.51 NA 6.8 NA NA NA NA NA 5.25 NA 3.2 0.96 12.8 NA 11.7 NA 12.6 NA NA NA NA NA 10.5 NA 19 4.04 14.60 8.60 12.20 11.9 19.4 17 – – 8.5 8 15.70 5.3 21.6 5.08 EBL = estimated blood loss; LRP = laparoscopic radical prostatectomy; NA = Clavien grading system not applied.
– – 1.14 – 5.4 1.17 – 1.3 – – 3.1 5.3 6 1.25 0 0 0.10 0.54 0 – 1.60 0.90 – – 0.30 – 0.48 0 (0.08% LRP) 1.60 1.30 1.50 0.5 3 – – 0.80 1.30 5.1 2.50 – 5.5 0.48 250 196 142 200 609 – 150 140 216 – – 402 300 113 186 130 154 171 166 – – 207 184 236 186 219 184 95 62.1 60 60.2 62 62 59.3 59.2 60 59.6 61 60.2 63.5 62.3 61 322 325 2766 184 133 629 362 660 700 294 400 321 415 2500 2006 2006 2007 2007 2007 2007 2008 2008 2009 2009 2009 2009 2009 2010 Hu et al. [19] Joseph et al. [20] Badani et al. [13] Mottrie et al. [21] Rozet et al. [22] Nelson et al. [23] Schroeck et al. [24] Chan et al. [25] Zorn et al. [26] Krambeck et al. [27] Murphy et al. [14] Ham et al. [28] Novara et al. [15] Current series
Mean hospital length of stay, d Open conversion Percentage transfused, % Mean EBL, ml Mean operative time, min Median/ mean age, yr Patients (n) Yr Reference
Table 5 – Perioperative parameters and complication rates in contemporary robotic-assisted radical prostatectomy series
Overall complication rate, %
Incidence of minor complications (grades 1 and 2), %
Incidence of major complications (grades 3 and 4), %
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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 preoperatively, 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 evisceration, 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 nonabsorbable sutures at the camera port; currently, we close the fascia using 2-0 vicryl interrupted suture, and no complications 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 matchedpair 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
EUROPEAN UROLOGY 57 (2010) 945–952
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 perioperative 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 complication 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 complications, 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 complications was not possible.
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allow proper comparisons among different surgical techniques, 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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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; complication rates demonstrated a tendency to decrease as the surgeon’s experience increased. The use of standardized classification systems to analyze surgical complications will
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available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Priority – Prostate Cancer Editorial 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, USA
b
University of Central Florida School of Medicine, Orlando, Florida, USA
c
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sa˜o Paulo, Divisa˜o de Urologia, Sa˜o Paulo, Brazil
d
Divisione di Urologia, Istituto Europeo di Oncologia, Milan, Italy
e
Division of Urology, Faculty of Medical Sciences Santa Casa, Sa˜o Paulo, Brazil
Article info
Abstract
Article history: Received 12 December 2009 Accepted February 3, 2010 Published online ahead of print on February 13, 2010
Background: Perioperative complications following robotic-assisted radical prostatectomy (RARP) have been previously reported in recent series. Few studies, however, have used standardized 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 complications following RARP in 2500 consecutive patients. Design, setting, and participants: We analyzed 2500 patients who underwent RARP for treatment of clinically localized prostate cancer (PCa) from August 2002 to February 2009. Data were prospectively 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. Complications were classified using the Clavien grading system. To evaluate trends regarding complications 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 rate was 0.08%, comprising two procedures converted to standard laparoscopy due to robot malfunction. One hundred and forty complications were observed in 127 patients (5.08%). The following percentages 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 or death (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 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; complication rates demonstrated a tendency to decrease as the surgeon’s experience increased.
Keywords: Prostatectomy Complications Robotics Prostatic neoplasm
# 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Global Robotics Institute, 410 Celebration Place, Celebration, FL 34747 USA. Tel. +1 407 303 46 73; Fax: +1 407 303 46 32. E-mail address: vipul.patel.md@flhosp.org (V.R. Patel). 0302-2838/$ – see back matter # 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
doi:10.1016/j.eururo.2010.02.001
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1.
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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 maintaining their baseline quality of life. Since Reiner and Walsh [2] first introduced the anatomic nerve-sparing technique for radical retropubic prostatectomy (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 invasive surgical approach to treating 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, has raised new hopes of reducing 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 complications, and that inconsistency has hampered accurate comparisons between different series or surgical
approaches. Based on these limitations, Clavien and colleagues proposed a grading system for surgical complications 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. Complications 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
Table 1 – Classification of surgical complications: Clavien grading system [6] Grade* 1
2 3 4 5 *
Description Any deviation from the normal postoperative course with no specific treatment required. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside. Requiring pharmacologic treatment with drugs other than such allowed for grade 1 complications. Blood transfusions and total parenteral nutrition are also included. Complications requiring surgical, endoscopic, or radiologic intervention (grade 3b if under general anesthesia and grade 3a if not). Any life-threatening complication requiring intermediate or intensive care (grade 4a for single-organ dysfunction and grade 4b for multiple-organ dysfunction). Death of a patient.
If the patient suffers from a complication at the time of discharge, the suffix ‘‘d’’ (for disability) is added to the respective grade of complication. This label indicates the need for follow-up to fully evaluate the complication.
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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 unscheduled 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 ischemic disease). Ileus was defined as postoperative nausea, vomiting, and/or
Table 2 – Preoperative patient characteristics Patient characteristics Age, yr, median (IQR) BMI, kg/m2, median (IQR) PSA level, ng/ml, median (IQR) Prostate weight, g, median (IQR) AUA-SS, median (IQR) Biopsy Gleason score, % 6 7 8 Pathologic stage, % pT2 pT3 pT4 Positive surgical margin rates, % Overall pT2 pT3 Pathologic Gleason score, % 6 7 8
61 (55–66) 28 (26–31) 4.9 (3.8–6.7) 48 (40–59) 7 (3–12) 64 28.5 7.5 75 24.3 0.7 10.6 5 27.5 42 51.8 6.2
AA-SS = American Urological Association symptom score; BMI = body mass index; IQR = interquartile range; PSA = prostate-specific antigen.
44.5% of our patients. Our conversion rate was 0.08%, comprising two procedures converted to standard laparoscopy 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 inhospital stay was 1 d. Finally, the median catheterization time was 5 d (IQR: 4–6 d).
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
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
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EUROPEAN UROLOGY 57 (2010) 945–952
Table 3 – Complications in a cohort of 2500 robotic-assisted radical prostatectomies No. of occurrences* (n = 127)
Complications Intraoperative Rectal injury
2
*
Incidence, %
–
0.08
12 5 5 18 3 5 1 2 2 1
2 4a 4a 2 2 2, 3b 3b 2, 3b 3b 3b
0.48 0.20 0.20 0.72 0.12 0.2 0.04 0.08 0.08 0.04
35 13 14 3 3 9 1 1 4 1 140
1d 1d 2 3b 3b 1, 3a 2 3a 2 3a –
1.40 0.52 0.56 0.12 0.12 0.36 0.04 0.04 0.16 0.04 –
Perioperative (before hospital discharge) Blood transfusion Myocardial infarction Pulmonary embolus Ileus Deep vein thrombosis Wound dehiscence Bowel herniation through trocar site Bowel obstruction Reoperation, bleeding Cholecystitis Postoperative (after hospital discharge) Anastomotic leakage Urinary retention Wound infection Incisional hernia Bladder neck contracture Symptomatic lymphocele Epididymitis Meatal stenosis Urinary tract infection Clip eroding through anastomosis Total
Clavien grade
Patients who experienced multiple complications were counted more than once.
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 Clavien grade 1 2 3a 3b 4a 4b 5 Total 1+2 3 + 4a
No. of patients
Percentage of patients, %
56 45 2 12 10 0 0 125 101 24
44.80 36 1.6 9.60 8.00 0 0 100 80.8 19.2
Incidence, %
2.24 1.8 0.08 0.48 0.40 0 0 – 4.04 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 cholecystitis, 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
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Fig. 2 – Anastomotic leakage rates versus surgeon’s experience. Fig. 1 – Complication rates versus surgeon’s experience.
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 increased ( p < 0.001; Fig. 2). 4.
Discussion
Direct comparisons among RRP, LRP, and RARP complication 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 complications 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 catheterization. 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 technique, and this change might also have had a role in the reduction of our anastomotic leakage rates [18]. Nevertheless, 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.
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1.8 NA 0.51 NA 6.8 NA NA NA NA NA 5.25 NA 3.2 0.96 12.8 NA 11.7 NA 12.6 NA NA NA NA NA 10.5 NA 19 4.04 14.60 8.60 12.20 11.9 19.4 17 – – 8.5 8 15.70 5.3 21.6 5.08 EBL = estimated blood loss; LRP = laparoscopic radical prostatectomy; NA = Clavien grading system not applied.
– – 1.14 – 5.4 1.17 – 1.3 – – 3.1 5.3 6 1.25 0 0 0.10 0.54 0 – 1.60 0.90 – – 0.30 – 0.48 0 (0.08% LRP) 1.60 1.30 1.50 0.5 3 – – 0.80 1.30 5.1 2.50 – 5.5 0.48 250 196 142 200 609 – 150 140 216 – – 402 300 113 186 130 154 171 166 – – 207 184 236 186 219 184 95 62.1 60 60.2 62 62 59.3 59.2 60 59.6 61 60.2 63.5 62.3 61 322 325 2766 184 133 629 362 660 700 294 400 321 415 2500 2006 2006 2007 2007 2007 2007 2008 2008 2009 2009 2009 2009 2009 2010 Hu et al. [19] Joseph et al. [20] Badani et al. [13] Mottrie et al. [21] Rozet et al. [22] Nelson et al. [23] Schroeck et al. [24] Chan et al. [25] Zorn et al. [26] Krambeck et al. [27] Murphy et al. [14] Ham et al. [28] Novara et al. [15] Current series
Mean hospital length of stay, d Open conversion Percentage transfused, % Mean EBL, ml Mean operative time, min Median/ mean age, yr Patients (n) Yr Reference
Table 5 – Perioperative parameters and complication rates in contemporary robotic-assisted radical prostatectomy series
Overall complication rate, %
Incidence of minor complications (grades 1 and 2), %
Incidence of major complications (grades 3 and 4), %
EUROPEAN UROLOGY 57 (2010) 945–952
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 preoperatively, 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 evisceration, 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 nonabsorbable sutures at the camera port; currently, we close the fascia using 2-0 vicryl interrupted suture, and no complications 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 matchedpair 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
EUROPEAN UROLOGY 57 (2010) 945–952
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 perioperative 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 complication 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 complications, 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 complications was not possible.
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allow proper comparisons among different surgical techniques, 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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