comparison of robot-assisted radical prostatectomy and ... · 1165 introduction abbou, et al. first...

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INTRODUCTION

Abbou, et al. first performed robot-assisted radical prostatec-tomy (RARP) in 2000.1 Since then, the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) has been used in South Korea to conduct various types of urological surgery including radical prostatectomy, partial nephrectomy, and radical cys-tectomy, beginning in 2005.2 Radical prostatectomy is consid-ered the gold standard of surgical treatment.3 However, the demand for RARP has increased due to better defined surgical anatomy and improved surgical maneuverability.2 Thirty-six da Vinci robotic surgery platforms are currently in use through-out 30 hospitals in Korea. A total of 24207 (24337 cases) patients underwent robotic surgery from 2005 to 2012, and the average

Comparison of Robot-Assisted Radical Prostatectomy and Open Radical Prostatectomy Outcomes: A Systematic Review and Meta-Analysis

Hyun-Ju Seo1,2*, Na Rae Lee2,3*, Soo Kyung Son2,3, Dae Keun Kim4, Koon Ho Rha5, and Seon Heui Lee6

1Department of Nursing, College of Medicine, Chosun University, Gwangju;2Department of Health Technology Assessment, National Evidence-based Healthcare Collaborating Agency, Seoul;3Department of Health Policy and Hospital Management, Graduate School of Public Health, Korea University, Seoul;4Department of Urology, CHA Gangnam Medical Center, CHA University, Seoul;5Department of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul;6Department of Nursing Science, College of Nursing, Gachon University, Incheon, Korea.

Purpose: To systematically update evidence on the clinical efficacy and safety of robot-assisted radical prostatectomy (RARP) ver-sus retropubic radical prostatectomy (RRP) in patients with prostate cancer.Materials and Methods: Electronic databases, including ovidMEDLINE, ovidEMBASE, the Cochrane Library, KoreaMed, KMbase, and others, were searched, collecting data from January 1980 to August 2013. The quality of selected systematic reviews was assessed using the revised assessment of multiple systematic reviews and the modified Cochrane Risk of Bias tool for non-randomized studies.Results: A total of 61 studies were included, including 38 from two previous systematic reviews rated as best available evidence and 23 additional studies that were more recent. There were no randomized controlled trials. Regarding safety, the risk of complications was lower for RARP than for RRP. Among functional outcomes, the risk of urinary incontinence was lower and potency rate was signifi-cantly higher for RARP than for RRP. Regarding oncologic outcomes, positive margin rates were comparable between groups, and although biochemical recurrence (BCR) rates were lower for RARP than for RRP, recurrence-free survival was similar after long-term follow up.Conclusion: RARP might be favorable to RRP in regards to post-operative complications, peri-operative outcomes, and functional outcomes. Positive margin and BCR rates were comparable between the two procedures. As most of studies were of low quality, the results presented should be interpreted with caution, and further high quality studies controlling for selection, confounding, and selective reporting biases with longer-term follow-up are needed to determine the clinical efficacy and safety of RARP.

Key Words: Prostatic neoplasms, robotics, prostatectomy, meta-analysis

Original Article

pISSN: 0513-5796 · eISSN: 1976-2437

Received: November 11, 2015 Revised: April 8, 2016Accepted: July 8, 2016Co-corresponding authors: Dr. Seon Heui Lee, Department of Nursing Science, College of Nursing, Gachon University, 191 Hambangmoe-ro, Yeonsu-gu, Incheon 21936, Korea.Tel: 82-32-820-4235, Fax: 82-32-820-4201, E-mail: [email protected] andDr. Koon Ho Rha, Department of Urology, Urological Science Institute, Yonsei Uni-versity College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea.Tel: 82-2-2228-2318, Fax: 82-2-312-2538, E-mail: [email protected]

*Hyun-Ju Seo and Na Rae Lee contributed equally to this work.•The authors have no financial conflicts of interest.

© Copyright: Yonsei University College of Medicine 2016This is an Open Access article distributed under the terms of the Creative Com-mons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and repro-duction in any medium, provided the original work is properly cited.

Yonsei Med J 2016 Sep;57(5):1165-1177http://dx.doi.org/10.3349/ymj.2016.57.5.1165

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SR and MA of RARP Compared to RRP for Prostate Cancer

http://dx.doi.org/10.3349/ymj.2016.57.5.1165

annual growth rate for robotic surgery was 51.4% from 2005 to 2011. One-third (33.7%) of all robotic surgeries in the world were RARP; this was the most commonly performed robotic procedure.4

In 2013, the Korean government announced plans to radi-cally enhance health insurance coverage for major conditions including cancer. Robotic surgery to treat prostatic cancer was to be included in the discretionary benefits list by as early as 2015.5 However, its inclusion has been questioned by some, since the comparative effectiveness of robotic surgery re-mains unclear. In previous reviews of RARP versus retropubic radical prostatectomy (RRP), RARP yielded better peri-opera-tive outcomes.6,7 However, the evidence suggesting that RARP is associated with a decrease in urinary incontinence, improved potency, and reduction in biochemical recurrence (BCR), com-pared to RRP is limited. This is because most publications had a high risk of bias and exhibited extensive patient heterogene-ity. While some experts have argued that the extension of dis-cretionary benefits to robotic surgery increases patient choice, others point out that, without scientific evaluation, expansion of coverage will undermine the National Health Insurance sys-tem because demand will explode.8

Accordingly, the aim of the present paper was to compre-hensively review and update data on the efficacy and safety of RARP versus RRP in patients with prostate cancer.

MATERIALS AND METHODS

Inclusion criteriaStudies eligible for inclusion consisted of randomized con-trolled trials and prospective and retrospective cohort studies that compared RARP and RRP. A study was excluded if it did not report any outcome of interest (i.e., safety or functional and oncological outcomes).

Search strategy We systematically reviewed recent research using techniques that evaluated comparative effectiveness, as suggested by the Agency for Healthcare Research and Quality.9

Existing systematic reviews and health technology assess-ment reports were identified by searching ovidMEDLINE, ovidEMBASE, the Cochrane Library, KoreaMed, RISS4U, KISS, KISTI, KMbase, and NDSL from January 1980 to August 2013. We used combinations of MeSH terms and the following phrases: exp Prostatic Neoplasms/or prostatic cancer, exp Ro-botics/or exp Surgery; and Computer-Assisted/or robot*/or (da vinci or davinci) (Supplementary Table 1, only online). In ad-dition, we scanned the reference lists of relevant reviews and reports by international health technology assessment agen-cies to ensure comprehensive data collection. We then searched for recent studies (published from January 2010 to September 2013), because two high-quality systematic reviews (HIQA10;

Ramsay, et al.11) had only searched primary studies up to March 2011. We did not restrict publication language.

Two authors independently reviewed all titles and abstracts and retrieved full-texts of all studies potentially meeting inclu-sion criteria. If the reviewing authors disagreed, the conflict was resolved by discussion and consensus, or by consulting a third member of the review team. We used structured data ex-traction forms to gather pertinent information; this included characteristics of the country of publication, study design, study participants, interventions, comparisons, outcome measures, outcome definitions, follow-up durations, and results that were statistically significant. If information was unclear or missing, we contacted the original authors by e-mail.

Quality assessment and data synthesis Two reviewers independently assessed the risk of bias. System-atic reviews were evaluated using the Revised Assessment of Multiple Systematic Reviews (R-AMSTAR) tool,12 and non-ran-domized studies newly published after 2010 were evaluated using the modified Cochrane Risk of Bias tool.11 The modified RoB tool is composed of seven specific domains: random se-quence generation (selection bias), allocation concealment (selection bias), controlling for confounding (selection bias), blinding (performance and detection bias), incomplete out-come data (attrition bias), selective outcome reporting (report-ing bias), and other sources of bias (regarding funding source). Any disagreement was resolved by discussion.

Meta-analysis was performed using Revman 5.2 and Com-prehensive Meta-Analysis (CMA) version 2.0. For continuous outcomes, weighted mean differences or standardized mean difference and 95% confidence intervals (CIs) were calculated using the random-effects model of the Dersimonian-Laird method.13 Mantel-Haenszel risk ratios (M-H RRs), with 95% CIs, derived using a random effects model, were calculated if outcomes were dichotomous.14 Heterogeneity was assessed using the I2 and Q statistics. An I2>50% was considered to indi-cate substantial heterogeneity.15 With the Q statistic, heteroge-neity was deemed to be significant if p<0.10. Publication bias was tested by Funnel plotting and using Egger’s test.16

RESULTS

Details of included studiesAn overview of the study selection process is provided in Fig. 1. We used two existing systematic reviews on RARP in pa-tients with prostate cancer as the best-available evidence, which included 38 studies. An additional twenty-three studies were included through new searches for updates. Finally, we evalu-ated 61 articles, none of which was a randomized controlled clinical trial (Supplementary Table 2, only online). In charac-teristic of the included studies, the average age of the partici-pants ranged from late fifties to sixties, which were similar be-

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tween the two procedures. Of the 61 studies, 14 reported sig-nificantly different pre-operative prostate-specific antigen (PSA) levels. Also, 22.9% of the included studies reported significantly higher clinical stages for RRP patients than for RARP patients.

Quality assessment resultsThe summary of risk of bias in the cohort studies is shown in Fig. 2. In this evaluation, random sequence generation and concealment of allocation to group were considered to be im-portant in terms of estimating any treatment effect. Most stud-ies were flawed in this respect. Accordingly, most of the stud-ies were susceptible to selection bias. Blinding domain was rated as a low risk of bias because of objective outcome mea-sures or patient reported outcomes using valid and reliable questionnaires. In the selective outcome reporting domain, approximately 40% of the included studies were rated as hav-ing a high or unclear risk of bias, because those studies did not investigate all of the outcomes of interest in this review.

Perioperative outcomes

ComplicationsThere was no significant difference in the rates of anastomosis

site leakage (eight studies with 4880 participants; RR 0.78, 95% CI 0.47–1.28; p=0.330), infection (six studies with 7373 partici-pants; RR 0.37, 95% CI 0.09–1.54; p=0.770), ileus (six studies with 2437 participants; RR 0.82, 95% CI 0.41–1.66; p=0.580), or deep vein thrombosis (five studies with 4576 participants; RR 0.75, 95% CI 0.39–1.46; p=0.400) between RARP and RRP in the selected studies (Supplementary Table 3, only online). How-

Fig. 1. Study selection flow-diagram.

Step 1 Step 2

Ovid MEDLINE (n=244)Ovid EMBASE (n=339)Cochrane Library (n=126)HTAi&INAHTA (n=16)

Oversea (n=4523)Ovid MEDLINE (n=986)Ovid EMBASE (n=3434)Cochrane Library (n=103)

Domestic (n=313)KoreaMed (n=70)KISS (n=162)RISS (n=2)KMbase (n=79)

Records after duplicates removed (n=536)

Records after duplicates removed(n=3896)

Records screened(n=110)

Records screened(n=95)

Full-text articles assessed for eligibility

(n=44)

Full-text articles excluded, with reasons (n=21)• Not reporting outcomes of

interest (n=9)• Not a comparative study

(n=4)• Gray literatures (n=1)• Claims database (n=7)

Studies included in qualitative synthesis

(n=23)

Studies included in quantitative synthesis (meta-analysis) (n=23)

Records excluded(n=51)

Systematic reviews published since 2010

(n=27)

Identified high quality SR(SR n=3)

(n=38 studies)

Iden

tifica

tion

Scre

enin

gEl

igib

ility

Inclu

ded

Fig. 2. The summary of risk of bias.

Other risk of bias

Selective reporting

Incomplete outcome data

Blinding

Confounding

Allocation concealment

Random sequence generation

0% 20% 40% 60% 80% 100%

High risk Unclear risk Low risk

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ever, RARP was associated with lower rates of bladder neck contracture (five studies with 2846 participants; RR 0.26, 95% CI 0.09–0.73; p=0.010), organ injury (ten studies with 6715 participants; RR 0.54, 95% CI 0.30–0.99; p=0.040), and pulmo-nary embolism (three studies with 3159 participants; RR 0.24, 95% CI 0.07–0.83; p=0.002), compared to RRP (Supplementary Fig. 1A, B, and C, respectively, only online). Transfusion data were reported in 25 studies (10605 participants). Although high degrees of study heterogeneity were evident, RARP was associated with a lower risk of transfusion than RRP in both prospective (12 studies with 6038 participants; RR 0.19, 95% CI 0.11–0.30; p<0.001) and retrospective studies (13 studies with 4567 participants; RR 0.14, 95% CI 0.07–0.30; p<0.001) (Supplementary Fig. 1D, only online).

Clavien-Dindo classificationData from 19 studies (12175 participants) indicated a slight, but significant, difference in Clavien-Dindo complication rates af-ter RARP, compared to RRP (RR 0.37, 95% CI 0.25–0.55, I2= 84%; p<0.001). When complications were classified by severi-ty, Clavien-Dindo I–II scores (11 studies with 5295 partici-pants) and Clavien-Dindo III–V (8 studies with 6880 partici-pants) scores suggested that RARP was associated with a decreased risk of Clavien-Dindo scores of I–II (RR 0.27, 95% CI 0.16–0.46, I2=88%; p<0.001) However, studies reporting such outcomes exhibited substantial heterogeneity (Supplementary Fig. 1E, only online).

Operation time RARP was associated with longer operating times than RRP (25 studies with 8080 participants; mean difference 32.27 min more; 95% CI: 12 to 52.54 min; p=0.002). Heterogeneity among study data was high (I2=98%) (Supplementary Fig. 1F, only online).

Length of stay Hospital days were reported in 27 studies (7939 participants). Sub-group analysis was carried out by classifying countries into the US, Asia-Pacific, and Europe. RARP was associated with shorter hospital stay in the US (13 studies with 5112 partic-ipants; mean difference -0.66 days, 95% CI -1.19–-0.14; p= 0.010), Asia-Pacific (five studies with 1256 participants; mean difference -3.39 days, 95% CI -4.11–-2.67; p<0.001), and Eu-rope (nine studies with 1571 participants; mean difference -1.81 days, 95% CI -2.76–-0.86; p<0.001). Considerable hetero-geneity was evident between studies (I2=99%), possibly attrib-utable to differences in healthcare systems (Supplementary Fig. 1G, only online).

Functional outcomes

Incontinence rate at 12 monthsBased on the results of 11 studies (participants: 2510), RARP was associated with reduced urinary incontinence 12 months

after surgery, compared to RRP (RR 0.62, 95% CI 0.42–0.93, I2= 47%; p=0.020) (Fig. 3A). In order to consider differences in ba-seline characteristics of participants, subgroup analysis was performed. In 10 studies with a similar pre-operative PSA lev-el between groups, urinary incontinence rate at 1 year after sur-gery was lower for RARP than for RRP (participants: 2214; RR 0.66, 95% CI 0.45–0.99, I2=45%; p=0.040). Also, pre-operative clinical stage for all of the studies was not significantly differ-ent between procedure groups.

Potency rate at 12 monthsBased on the results of 10 studies (participants: 2142), RARP was found to be associated with improved postoperative po-tency rate, compared to RRP (RR 1.41, 95% CI 1.18–1.70, I2= 65%; p<0.001) (Fig. 3B). In addition, nine studies (participants: 1956) with a similar pre-operative PSA level between groups demonstrated favorable potency rate for RARP (RR 1.41, 95% CI 1.16–1.72, I2=63%; p<0.001). In eight studies (participants: 1965) with comparable pre-operative clinical stages between groups, RARP was associated with higher recovery of erectile function (RR 1.37, 95% CI 1.12–1.67, I2=69%; p=0.002).

Oncological outcomes

Positive margin ratesPositive margin rates for RARP were equivalent to those for RRP in both prospective (13 studies, 6226 participants; RR 0.95, 95% CI 0.74–1.23, I2=80%; p=0.72) and retrospective studies (23 studies, 12813 participants; RR 0.88, 95% CI 0.75–1.03, I2=71%; p=0.110) (Fig. 4A). However, the heterogeneity among the re-sults of individual studies was considerable. Sensitivity analy-sis was performed with only low risk studies (seven studies with 1412 participants; RR 0.93, 95% CI 0.67–1.30, I2=65%; p=0.670) (Fig. 4B) and for pT2 tumors in studies published after 2010 (7 studies with 2321 patients; RR 0.73, 95% CI 0.45–1.19, I2=73%; p=0.210) to determine the effect of removing any outliers. How-ever, there was still moderate heterogeneity (Fig. 4C).

Biochemical recurrenceFourteen studies (8259 participants) reported recurrence of prostate cancer, defined at various cut-off values of >0.4 ng/mL, >0.2 ng/mL, ≥2 ng/mL, >0.1 ng/mL, or ≥0.1 ng/mL. Therefore, the subgroup analysis was performed according to definition of PSA failure. Rates of BCR were reported in five studies (1485 participants) using the definition PSA level >0.2 ng/mL.17-21 RARP was associated with a reduced risk of BCR, compared to RRP (RR 0.71, 95% CI 0.61–0.81, I2=0%; p<0.001) (Fig. 5A). Sub-group analysis according to follow-up duration demonstrated a similar recurrence-free survival between the two procedures upon long-term follow up (Fig. 5B).

Publication biasPublication bias for each outcome was tested using Egger’s re-

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gression test, and showed only one example of publication bias associated with reported transfusion rates (Supplementary Table 4, only online). So, trill and fill analysis was performed to adjust the publication bias. After excluding eight studies by trim-and-fill analysis, the risk ratio of transfusion rate was still lower in RARP than in RRP (RR 0.26, 95% CI 0.17–0.38).

DISCUSSION

To explore the supposed superiority of robotic platforms in treating prostate cancer, we performed a systematic review of all research published to 2013 that compared RARP with RRP.

We found no randomized controlled study in which the two modalities were compared. Thus, we included only 61 non-randomized studies, of which 20 were prospective and 41 were retrospective. Studies were regarded as being of high quality if three of four domains (random sequence generation, con-founding, blinding, and incomplete outcome reporting) were judged to have a low risk of bias. Only 13 (21.3%) publications met these criteria, and the risk of bias in most of the studies might confound the true effects of RARP.

Since 2010, 23 systematic reviews have been published, and they reported various outcomes. Our systematic review in-cluded recently published studies and reflects comprehensive primary outcomes, including perioperative outcomes, func-

RARP RRP Risk ratio Risk ratioStudy or subgroup Events Total Events Total Weight M-H, random, 95% CI Year M-H, random, 95% CI

Ham, et al.50 109 188 33 110 12.8% 1.93 [1.42, 2.64] 2008Krambeck, et al.53 174 248 309 492 18.8% 1.12 [1.00, 1.24] 2009

Ficarra, et al.69 52 64 20 41 12.1% 1.67 [1.19, 2.33] 2009

Nadler, et al.58 8 22 0 4 0.5% 3.70 [0.25, 54.07] 2010

Rocco, et al.25 48 79 88 215 15.0% 1.48 [1.17, 1.89] 2009

Ou, et al.19 14 16 1 2 1.6% 1.75 [0.43, 7.08] 2009

Hohwü, et al.35 31 77 68 154 12.4% 0.91 [0.66, 1.26] 2011

Di Pierro, et al.47 12 22 12 47 6.2% 2.14 [1.15, 3.97] 2011

Ludovico, et al.56 22 60 12 48 6.6% 1.47 [0.81, 2.65] 2013

Choo, et al.45 42 77 70 176 14.0% 1.37 [1.04, 1.80] 2013

Total (95% CI) 853 1289 100.0% 1.41 [1.18, 1.70]

Total events 512 613

Heterogeneity: tau2=0.04; chi2=25.78, df=9 (p=0.002); I²=65%

Test for overall effect: Z=3.67 (p=0.0002)

Fig. 3. Functional outcomes: RARP vs. RRP. (A) Incontinence rate at 12 months after surgery. (B) Potency rate at 12 months after surgery. RARP, robot-as-sisted radical prostatectomy; RRP, retropubic radical prostatectomy; CI, confidence interval.

0.01 0.1 1 10 100

0.02 0.1 1 10 50

Favours RARP

Favours RRP

Favours RRP

Favours RARP


Ham, et al.50 15 188 20 110 14.2% 0.44 [0.23, 0.82] 2008Nadler, et al.58 5 44 5 46 7.6% 1.05 [0.32, 3.36] 2010

Ou, et al.19 0 30 1 30 1.5% 0.33 [0.01, 7.87] 2009

Rocco, et al.25 2 79 26 217 5.8% 0.21 [0.05, 0.87] 2009

Ficarra, et al.69 6 103 17 105 10.5% 0.36 [0.15, 0.88] 2009

Krambeck, et al.53 20 244 30 476 15.5% 1.30 [0.75, 2.24] 2009

Di Pierro, et al.47 5 45 15 75 9.8% 0.56 [0.22, 1.43] 2011

Hohwü, et al.35 10 77 46 154 14.2% 0.43 [0.23, 0.81] 2011

Iseki, et al.34 5 44 15 60 9.9% 0.45 [0.18, 1.16] 2012

Ludovico, et al.56 4 82 1 48 2.9% 2.34 [0.27, 20.35] 2013

Choo, et al.45 5 77 7 176 8.1% 1.63 [0.53, 4.98] 2013

Total (95% CI) 1013 1497 100.0% 0.62 [0.42, 0.93]

Total events 77 183

Heterogeneity: tau2=0.19; chi2=18.96, df=10 (p=0.04); I2=47%


A

B

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Fig. 4. Positive margin rate: RARP vs. RRP. (A) Positive margin rate. RARP, robot-assisted radical prostatectomy; RRP, retropubic radical prostatectomy; CI, confidence interval.

0.2 0.5 1 2 5

Favours RARP Favours RRP

RARP RRP Risk ratio Risk ratioStudy or subgroup Events Total Events Total Weight M-H, random, 95% CI Year M-H, random, 95% CI1) Prospective cohort study

Tewari, et al.17 18 200 23 100 2.5% 0.39 [0.22, 0.69] 2003Wood, et al.68 21 117 8 89 1.8% 2.00 [0.93, 4.30] 2007Ham, et al.50 37 118 29 110 3.2% 1.19 [0.79, 1.79] 2008Fracalanza, et al.26 10 35 6 26 1.5% 1.24 [0.52, 2.97] 2008Ficarra, et al.69 35 103 21 105 2.9% 1.70 [1.06, 2.71] 2009Kordan, et al.52 171 830 132 414 4.1% 0.65 [0.53, 0.78] 2010Loeb, et al.21 22 152 25 137 2.7% 0.79 [0.47, 1.34] 2010Doumerc, et al.48 45 212 84 502 3.6% 1.27 [0.92, 1.75] 2010Breyer, et al.44 54 292 108 695 3.7% 1.19 [0.88, 1.60] 2010Kim, et al.70 143 528 58 235 3.8% 1.10 [0.84, 1.43] 2011Di Pierro, et al.47 11 74 23 72 2.2% 0.47 [0.25, 0.88] 2011Williams, et al.67 80 604 30 346 3.2% 1.53 [1.03, 2.27] 2010Ludovico, et al.56 8 82 14 48 1.7% 0.33 [0.15, 0.74] 2013Subtotal (95% CI) 3347 2879 37.0% 0.95 [0.74, 1.23]Total events 655 561Heterogeneity: tau²=0.16; chi²=59.36, df=12 (p<0.00001); I²=80%Test for overall effect: Z=0.36 (p=0.72)

2) Retrospective cohort studyAhlering, et al.43 10 60 12 60 1.8% 0.83 [0.39, 1.78] 2004Smith, et al.63 30 199 69 197 3.3% 0.43 [0.29, 0.63] 2007Schroeck, et al.61 106 362 122 435 4.0% 1.04 [0.84, 1.30] 2008Laurila, et al.54 11 88 12 84 1.8% 0.88 [0.41, 1.87] 2009Coronato, et al.46 12 98 14 57 2.0% 0.50 [0.25, 1.00] 2009Rocco, et al.25 26 120 60 240 3.2% 0.87 [0.58, 1.30] 2009Ou, et al.19 15 30 6 30 1.7% 2.50 [1.12, 5.56] 2009Drouin, et al.18 12 71 15 83 2.1% 0.94 [0.47, 1.86] 2009White, et al.66 11 50 18 50 2.2% 0.61 [0.32, 1.16] 2009Nadler, et al.58 5 50 12 50 1.3% 0.42 [0.16, 1.10] 2010Krambeck, et al.53 46 294 100 588 3.6% 0.92 [0.67, 1.27] 2009Barocas, et al.20 281 1413 148 491 4.2% 0.66 [0.56, 0.78] 2010Lo, et al.55 4 20 5 20 1.0% 0.80 [0.25, 2.55] 2010Uvin, et al.64 1 13 0 9 0.2% 2.14 [0.10, 47.38] 2010Magheli, et al.57 102 522 75 522 3.8% 1.36 [1.04, 1.79] 2011Philippou, et al.59 9 50 10 50 1.7% 0.90 [0.40, 2.02] 2012Hong, et al.51 52 182 46 80 3.7% 0.50 [0.37, 0.67] 2012Wang, et al.65 160 1038 95 707 4.0% 1.15 [0.91, 1.45] 2012Punnen, et al.60 68 233 40 177 3.5% 1.29 [0.92, 1.81] 2013Iseki, et al.34 17 44 23 60 2.8% 1.01 [0.62, 1.65] 2012Froehner, et al.49 33 252 242 1925 3.5% 1.04 [0.74, 1.46] 2013Silberstein, et al.62 74 493 147 691 3.9% 0.98 [0.76, 1.27] 2013Choo, et al.45 30 77 70 178 3.5% 0.99 [0.71, 1.38] 2013Subtotal (95% CI) 5759 7054 63.0% 0.88 [0.75, 1.03]Total events 1115 1341Heterogeneity: tau²=0.09; chi²=76.49, df=22 (p<0.00001); I²=71%Test for overall effect: Z=1.58 (p=0.11)

Total (95% CI) 9106 9933 100.0% 0.91 [0.79, 1.04]Total events 1770 1902Heterogeneity: tau²=0.10; chi²=136.83, df=35 (p<0.00001); I²=74%Test for overall effect: Z=1.41 (p=0.16) Test for subgroup differences: chi²=0.28, df=1 (p=0.60); I²=0%

A

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tional outcomes, and oncologic outcomes. Compared to open surgery, RARP yielded superior outcomes in terms of compli-cations, such as organ injury, pulmonary embolism, and bladder neck contracture. In addition, the risk of overall com-plications assessed using the Clavien-Dindo classification was lower for RARP than RRP, although a high level of study het-erogeneity was evident. Notably, the risk of complications af-ter RARP was significantly lower than that after RRP, unlike earlier reports.7,11 Our findings are in line with results reported elsewhere. That is, a population-based observational cohort study using US Surveillance, Epidemiology, and End Results Medicare-linked data found that minimally invasive radical prostatectomy with or without robotic assistance was associ-ated with lower rates of postoperative respiratory complica-tions (4.3% vs. 6.6%; p=0.004), miscellaneous surgical compli-cations (4.3% vs. 5.6%; p=0.03), and anastomotic stricture (5.8% vs. 14.0%; p<0.001), compared to RRP.22 In addition, RARP postoperative courses based on claims made to the South Korean Health Insurance Review and Assessment Service from September 2005 to December 2011 might be lower than

RRP. Totals of 1830 and 1660 patients underwent RARP and RRP, respectively, and postoperative complication rates to 30 days as measured by re-admission to intensive care units were 0.1% and 0.2%, respectively.23 Thus, we suggest that RARP can be performed with a reasonably low complication rate.

In the present study, RARP was associated with better peri-operative outcomes than RRP in terms of operation time and length of hospital stay, consistent with findings of previous sys-tematic reviews and meta-analyses.7,24 In addition, claims data from South Korea showed that RARP-associated hospital stays were shorter than those for RRP (RARP 9 days vs. RRP 12.7 days). We sought to explore heterogeneity in pooled estimates of operative time by performing subgroup analysis according to the definition of operative time, but could not do so because most studies did not describe how they measured the dura-tion of surgery. Only four studies reported durations of sur-gery as follows: from skin incision to skin closure time in both procedures;25 from insertion of the Veress needle (RARP) to the suture of the last laparoscopic port, and skin incision to suture (RRP);26 as the time from incision to placement of dressings;27

0.01 0.1 1 10 100

0.02 0.1 1 10 50

Favours RRP

Favours RRP

Favours RARP

Favours RARP


Rocco, et al.25 26 120 60 240 17.3% 0.87 [0.58, 1.30] 2009Ficarra, et al.69 35 103 21 105 16.0% 1.70 [1.06, 2.71] 2009

White, et al.66 11 50 18 50 12.5% 0.61 [0.32, 1.16] 2009

Philippou, et al.59 9 50 10 50 9.8% 0.90 [0.40, 2.02] 2012

Iseki, et al.34 17 44 23 60 15.5% 1.01 [0.62, 1.65] 2012

Punnen, et al.60 68 233 40 177 18.8% 1.29 [0.92, 1.81] 2013

Ludovico, et al.56 8 82 14 48 10.1% 0.33 [0.15, 0.74] 2013

Total (95% CI) 682 730 100.0% 0.93 [0.67, 1.30]


Heterogeneity: tau²=0.12; chi²=17.23, df=6 (p=0.008); I²=65%



Nadler, et al.58 2 46 3 33 5.8% 0.51 [0.09, 2.89] 2010Doumerc, et al.48 17 146 13 54 16.0% 0.48 [0.25, 0.93] 2010

Di Pierro, et al.47 5 60 13 54 11.9% 0.35 [0.13, 0.91] 2011

Magheli, et al.57 36 387 24 364 18.2% 1.41 [0.86, 2.32] 2011

Hong, et al.51 35 148 30 61 19.8% 0.48 [0.33, 0.71] 2012

Philippou, et al.59 5 32 4 27 9.3% 1.05 [0.31, 3.54] 2012

Silberstein, et al.62 31 315 46 597 19.1% 1.28 [0.83, 1.97] 2013

Subtotal (95% CI) 1131 1190 100.0% 0.73 [0.45, 1.19]


Heterogeneity: tau²=0.27; chi²=22.16, df=6 (p=0.001); I²=73%


Fig. 4. Positive margin rate: RARP vs. RRP. (B) Positive margin rate of studies assessed as low risk studies. (C) Positive margin rate for pT2 tumors in studies published after 2010. RARP, robot-assisted radical prostatectomy; RRP, retropubic radical prostatectomy; CI, confidence interval.

B

C

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Fig. 5. Biochemical recurrence: RARP vs. RRP. (A) Biochemical recurrence according to definition of PSA failure. RARP, robot-assisted radical prostatecto-my; RRP, retropubic radical prostatectomy; CI, confidence interval.

0.05 0.2 1 5 20



1) PSA >0.4 ng/mLKrambeck, et al.53 14 248 32 492 7.8% 0.87 [0.47, 1.60] 2009Subtotal (95% CI) 248 492 7.8% 0.87 [0.47, 1.60]Total events 14 32Heterogeneity: not applicableTest for overall effect: Z=0.46 (p=0.65)

2) PSA >0.2 ng/mLTewari, et al.17 16 200 15 100 7.3% 0.53 [0.28, 1.03] 2003Drouin, et al.18 7 71 12 83 5.5% 0.68 [0.28, 1.64] 2009Ou, et al.19 6 30 5 30 4.3% 1.20 [0.41, 3.51] 2009Barocas, et al.20 181 425 155 257 12.1% 0.71 [0.61, 0.82] 2010Loeb, et al.21 7 152 7 137 4.6% 0.90 [0.32, 2.50] 2010Subtotal (95% CI) 878 607 33.8% 0.71 [0.61, 0.81]Total events 217 194Heterogeneity: tau²=0.00; chi²=1.85, df=4 (p=0.76); I²=0%Test for overall effect: Z=4.86 (p<0.00001)

3) PSA ≥2 ng/mLSchroeck, et al.61 29 362 54 435 9.6% 0.65 [0.42, 0.99] 2008Hohwü, et al.35 4 77 21 154 4.5% 0.38 [0.14, 1.07] 2011Punnen, et al.60 79 233 57 177 11.1% 1.05 [0.80, 1.39] 2013Choo, et al.45 5 77 23 176 5.1% 0.50 [0.20, 1.26] 2013Subtotal (95% CI) 749 942 30.4% 0.70 [0.44, 1.10]Total events 117 155Heterogeneity: tau²=0.12; chi²=7.78, df=3 (p=0.05); I²=61%Test for overall effect: Z=1.56 (p=0.12)

4) PSA >0.1 or PSA ≥0.1 ng/mLNadler, et al.58 4 50 3 50 2.8% 1.33 [0.31, 5.65] 2010Silberstein, et al.62 16 493 39 961 8.1% 0.80 [0.45, 1.42] 2013Subtotal (95% CI) 543 1011 10.9% 0.86 [0.50, 1.46]Total events 20 42Heterogeneity: tau²=0.00; chi²=0.42, df=1 (p=0.52); I²=0%Test for overall effect: Z=0.57 (p=0.57)

5) Not reportedMagheli, et al.57 28 522 17 522 8.0% 1.65 [0.91, 2.97] 2011Wang, et al.65 21 1038 70 707 9.1% 0.20 [0.13, 0.33] 2012Subtotal (95% CI) 1560 1229 17.1% 0.58 [0.07, 4.46]Total events 49 87Heterogeneity: tau²=2.11; chi²=29.04, df=1 (p<0.00001); I²=97%Test for overall effect: Z=0.53 (p=0.60)

Total (95% CI) 3978 4281 100.0% 0.71 [0.54, 0.93]Total events 417 510Heterogeneity: tau²=0.16; chi²=47.23, df=13 (p<0.00001); I²=72%Test for overall effect: Z=2.49 (p=0.01)Test for subgroup differences: chi²=0.91, df=4 (p=0.92); I²=0%

A

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and as the mean operative time of hernia repair.28

Our results are comparable with those of a propensity-score matching study that adjusted for among-series differences in preoperative Gleason scores, preoperative PSA levels, and pathological stages. The cited work comprised a systematic review and meta-analysis of RRP, laparoscopic radical prosta-tectomy, and RARP patient series, and found that the rate of

perioperative complications was significantly lower for RARP than RRP.24

The prevalence of urinary incontinence and erectile dysfunc-tion after RARP are affected by preoperative patient charac-teristics (age, body mass index, and comorbidities), the expe-rience of the surgeon, the surgical technique used, and me-thodological features, such as the definitions of continence and

Fig. 5. Biochemical recurrence: RARP vs. RRP. (B) Biochemical recurrence according to follow-up duration. RARP, robot-assisted radical prostatectomy; RRP, retropubic radical prostatectomy; CI, confidence interval.

0.005 0.1 1 10 200


RARP RRP Risk ratio Risk ratioStudy or subgroup Events Total Events Total Weight M-H, random, 95% CI Year M-H, random, 95% CI1) Follow-up duration ≤1 yr

Hohwü, et al.35 4 77 21 154 4.5% 0.38 [0.14, 1.07] 2011Wang, et al.65 21 1038 70 707 9.1% 0.20 [0.13, 0.33] 2012Subtotal (95% CI) 1115 861 13.6% 0.23 [0.14, 0.39]Total events 25 91Heterogeneity: tau²=0.03; chi²=1.15, df=1 (p=0.28); I²=13%Test for overall effect: Z=5.64 (p<0.00001)

2) 1<Follow-up duration≤2 yrsTewari, et al.17 16 200 15 100 7.3% 0.53 [0.28, 1.03] 2003Schroeck, et al.61 29 362 54 435 9.6% 0.65 [0.42, 0.99] 2008Ou, et al.19 6 30 5 30 4.3% 1.20 [0.41, 3.51] 2009Krambeck, et al.53 14 248 32 492 7.8% 0.87 [0.47, 1.60] 2009Magheli, et al.57 28 522 17 522 8.0% 1.65 [0.91, 2.97] 2011Silberstein, et al.62 16 493 39 961 8.1% 0.80 [0.45, 1.42] 2013Choo, et al.45 5 77 23 176 5.1% 0.50 [0.20, 1.26] 2013Subtotal (95% CI) 1932 2716 50.2% 0.81 [0.59, 1.10]Total events 114 185Heterogeneity: tau²=0.07; chi²=9.78, df=6 (p=0.13); I²=39%Test for overall effect: Z=1.34 (p=0.18)

3) More than 2 yrs follow-upNadler, et al.58 4 50 3 50 2.8% 1.33 [0.31, 5.65] 2010Drouin, et al.18 7 71 12 83 5.5% 0.68 [0.28, 1.64] 2009Barocas, et al.20 181 425 155 257 12.1% 0.71 [0.61, 0.82] 2010Punnen, et al.60 79 233 57 177 11.1% 1.05 [0.80, 1.39] 2013Subtotal (95% CI) 779 567 31.6% 0.84 [0.62, 1.14]Total events 271 227Heterogeneity: tau²=0.04; chi²=6.95, df=3 (p=0.07); I²=57%Test for overall effect: Z=1.12 (p=0.26)

4) Not reportedLoeb, et al.21 7 152 7 137 4.6% 0.90 [0.32, 2.50] 2010Subtotal (95% CI) 152 137 4.6% 0.90 [0.32, 2.50]Total events 7 7Heterogeneity: not applicableTest for overall effect: Z=0.20 (p=0.84)

Total (95% CI) 3978 4281 100.0% 0.71 [0.54, 0.93]Total events 417 510Heterogeneity: tau²=0.16; chi²=47.23, df=13 (p<0.00001); I²=72%Test for overall effect: Z=2.49 (p=0.01)Test for subgroup differences: chi²=20.44, df=3 (p=0.0001); I²=85.3%

B

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potency, outcome measures, and follow-up periods.29 To opti-mize our evaluation of functional outcomes, we included only outcome data obtained using objective measures or reliable and valid measurement instruments. In detail, the definition of continence was the use of no pad at all, 0–1 pads per day, or no leak measured by a validated questionnaire including the International Consultation of Incontinence Questionnaire-Urinary Incontinence; and that for erectile function a positive response to a validated questionnaire reporting erection suffi-cient for intercourse with or without prescription of a phos-phodiesterase type 5 inhibitor or a score >17 on the Sexual Health Inventory for Men or 5-item version of the International Index of Erectile Function validated questionnaires exploring erectile dysfunction.

In this review, urinary incontinence and erectile function recovery rates measured at 12 months after RARP were lower than those after RRP. Our findings suggest positive functional outcomes of RARP, because of an increase of magnitude in ef-fect size, compared to previous systematic review.11 The bene-ficial effects on the functional outcomes of RARP, compared to RRP, remained even in meta-analysis that added the study findings recently reported by Haglind, et al.30 [incontinence rate: 12 studies, 4937 participants, RR (M-H, random) 0.68, 95% CI 0.47–0.98, I2=62%; potency rate: 11 studies, 4564 partici-pants, RR (M-H, random) 1.36, 95% CI 1.18–1.57, I2=61%].

The positive effect of functional outcomes of RARP is attrib-utable to developments in surgical technique: nerve sparing improves both continence and potency, because the urethral rhabdosphincter receives afferent fibers from the traversing bundle.31 On robotic platforms, three-dimensional-magnified views allow meticulous dissection of both the periprostatic fas-cia layer and the neurovascular bundle. New insights into the multilayer structure of the periprostatic fascia and the course of the cavernous nerves have supported the development of intra- or inter-fascial surgical planes, enabling the urinary and sexual functional outcomes to be improved. Developments in RARP operative techniques improving urinary function, such as puboprostatic-sparing approaches, bladder neck preserva-tion, selective dorsal vein complex division, nerve-sparing mechanisms, reconstruction of the posterior musculofascia, and anterior restoration of the pelvic space, are advocated. Meanwhile, several physician-reported studies showed incon-tinence rates ranging from 10 to 15% at 12 months after radical prostatectomy.32,33 Considering that an acceptable inconti-nence rate is about 10%, regardless of the surgical technique, two studies included in this review might be performed by under-experienced surgeons due to a high incontinence rate, reaching 25 to 30%.34,35 Urinary incontinence and erectile dys-function are highly problematic conditions affecting many as-pects of quality of life, and healthcare providers must be aware of this.36-38 Although a randomized controlled study was not included in this review, our results suggest that healthcare providers should consider patient preferences in terms of re-

covery of urinary and erectile function when choosing be-tween RARP and RRP, even though disparities in the receipt of RARP in terms of demographic characteristics, such as house-hold income and insurance status, were reported.39

The rate of positive surgical margins was comparable be-tween RARP and RRP (RR 0.95, 95% CI 0.74–1.23, I2=80%). In sensitivity analysis to explore the heterogeneity, our results did not change in the analysis restricted to studies rated as low risk of bias and for pT2 tumors studies published after 2010. The results were consistent with the findings of previous sys-tematic reviews.22 Pooled estimates from 15 studies published from 2004 to 2011 showed that RARP is associated with a lower rate of positive surgical margins for pT2 tumors (RR 0.63, 95% CI 0.49–0.81, I2=27.7%).5 However, we suggest that our find-ings reflect more recent evidence of the comparative effective-ness of RARP versus RRP. Furthermore, this result was consis-tent with the recent cohort study investigating long-term oncologic outcomes, including positive surgical margins, in RARP compared to RRP (between group comparison p=0.230).40

In the present review, RARP was associated with a lower rate of BCR, compared to RRP, regardless of the manner in which such recurrence was defined (14 studies with 8259 pa-tients; RR 0.71, 95% CI 0.54–0.93, I2=72%). To explore the effect of heterogeneity, we classified studies in terms of their defini-tion of PSA failure, and selected PSA >0.2 ng/mL as an optimal criterion based on clinical practice guidelines.41 Upon sub-group analysis, RARP was superior to RRP in this context (five studies with 1485 patients; RR 0.71, 95% CI 0.61–0.81, I2=0%); heterogeneity was not an issue in this subgroup. This result is inconsistent with that of an earlier meta-analysis (hazard ratio 0.9, 95% CI 0.7–1.2, p=0.526), which reported differences in the definition of BCR-free survival.42 In additional analysis ac-cording to follow-up period, PSA failure rates were signifi-cantly lower in RARP than in RRP in a short term follow-up of 1 year or less. However, PSA failure rates between the two pro-cedures were similar in long-term follow up.

Our present review had several limitations. First, significant oncologic and functional heterogeneity was evident; surgical skills and experience vary. Second, no randomized controlled trial has been conducted. Third, virtually no significant report on cancer-specific mortality rate following RARP has been pub-lished, because of the long follow-up needed in prognostic studies on clinically localized prostate cancer and the fact that RARP is a relatively new procedure.

In conclusion, we found that RARP might be favorable to RRP in aspects of post-operative complications, peri-operative out-comes, and functional outcomes, including urinary and erec-tile function. Also oncologic outcomes, such as positive mar-gins and BCR, were comparable between two groups. However, most included studies were non-randomized studies and mod-erate to substantial heterogeneity was evident. Therefore, we suggest that further high quality studies minimizing selection, confounding, and selective reporting biases with longer-term

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follow-up are needed to determine clinical efficacy and safety of RARP.

ACKNOWLEDGEMENTS

This study was completed as part of the Health Technology Assessment Report (project no. NA 2013-007) funded by the National Evidence-based Healthcare Collaborating Agency in South Korea.

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