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Retropubic, Laparoscopic, or Robotic Radical Prostatectomy: Is There Any Real Difference?
Retropubic, Laparoscopic, or Robotic Radical Prostatectomy: Is There Any Real Difference? Kelly A. Healy and Leonard G. Gomella The surgical management of localized prostate cancer has evolved over the last 20 years. The “gold standard” open radical prostatectomy (ORP) has been replaced largely by the roboticassisted laparoscopic radical retropubic prostatectomy (RALP) as the most common surgical approach to treat localized prostate cancer. Pure laparoscopic radical prostatectomy (LRP), still performed by a limited number of surgeons, was more commonly utilized before the widespread availability of the robotically assisted technique. The general consensus based on the current literature is that RALP is associated with less blood loss and a shorter hospital stay but at a higher cost when compared to ORP. The literature continues to be conflicted concerning outcome measures such as impotence and urinary incontinence. Large series of long-term oncologic follow-up are not yet available; however, the data suggest that oncologic control is similar between RALP and ORP. Considerable disparities in measurement and reporting practices of perioperative outcomes continue to make direct comparisons difficult. Future prospective studies of perioperative outcomes should aim to use rigorous methodology and established criteria for standardized reporting. Semin Oncol 40:286-296 & 2013 Published by Elsevier Inc.
A
ccording to data from the nationwide inpatient sample in 2009 robotic-assisted laparoscopic radical prostatectomy (RALP) has supplanted open radical retropubic prostatectomy (ORP) as the most common surgical approach for radical prostatectomy (RP), accounting for 61% of cases reported.1 There is an overall impression that minimally invasive techniques such as laparoscopic radical prostatectomy (LRP) and RALP are convincingly superior to the traditional ORP techniques. We reviewed the existing literature with attention to the perioperative outcomes and oncologic outcomes reported comparing the newer laparoscopic techniques with existing ORP data in the management of localized prostate cancer.
PERIOPERATIVE OUTCOMES In an initial systematic review of the RALP literature until 2007, Ficarra et al noted a complication Department of Urology, Kimmel Cancer Center, Thomas Jefferson University Philadelphia, PA. Conflicts of interest: none. Address correspondence to Leonard G. Gomella, MD, Room 1102, 1025 Walnut St, Philadelphia, PA 19107. E-mail: leonard.gomella@jefferson. edu 0270-9295/ - see front matter & 2013 Published by Elsevier Inc. http://dx.doi.org/10.1053/j.seminoncol.2013.04.004
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rate ranging from 1.5%–20%.2 Importantly, most studies included in the review were case series or poor-quality case-control studies and therefore rated as level 4 evidence. In addition, these studies also represent the first reports published in the literature. As the surgeon’s experience increases, the operative time for RALP decreases significantly.3–5 During the learning curve phase, perioperative complications varied widely from 1%–42%.2 Operative times for the first 40 RALPs performed at the Vattikuti Institute during their structured training program compared favorably to those for LRP done by Guillonneau and Vallancien, two experienced French laparoscopists.4 In addition, RALP was associated with a significantly lower blood loss. Comparative studies from Menon et al of the first RALPs versus ORPs demonstrated that the robotic approach may require longer operative times but yields decreased blood loss, decreased blood transfusion, and less postoperative pain, as well as earlier hospital discharge.6 In this same review, Ficarra et al examined postoperative outcomes from mature RALP clinical series beyond the learning curve. Overall complication rates ranged between 1.5%–16%.2 All evaluated series reported minimal blood loss, with transfusion rates between 0%–12%. Less consistent was the duration of hospitalization, which is likely highly dependent on institutional practices, clinical pathways, and the Seminars in Oncology, Vol 40, No 3, June 2013, pp 286-296
Retropubic, laparoscopic, or robotic radical prostatectomy?
larger health care system. After overcoming the learning curve, mean operating times can be reduced to 180 minutes (range, 81–365).7 Similar results can be obtained using either an extraperitoneal or transperitoneal approach.8–11 Furthermore, equivalent operative times can be achieved in academic and community settings.12 Early comparative series of RALP and ORP have yielded conflicting results. Tewari et al compared the first 200 RALPs with 100 consecutive contemporary ORPs and found that operative times are similar once beyond the learning curve.13 The study also confirmed the benefits of the robotic-assisted approach, including decreased blood loss, transfusion rate, postoperative pain, and hospital stay. Ahlering et al reported similar findings in their institutional comparison of the last 60 RALPs from June 2003 to August 2004 to the last 60 ORPs in 2001 and 2002.14 On the other hand, Webster et al compared perioperative outcomes for 159 RALPs and 154 ORPs. The authors failed to find any significant improvements in postoperative pain15 or transfusion16 between the two approaches. Comparing RALP and LRP, two studies found no differences in operative times, transfusions, and postoperative complications.17,18 Based on this review of early studies, Ficarra et al concluded that RALP appears to be a feasible procedure with limited blood loss, favorable complication rates, and short hospital length of stay (LOS). Despite these initial experiences, the limited number of patients and lack of highquality data included in the review did not allow for definitive conclusions on perioperative outcomes. Following this initial RALP 2007 review, Ficarra et al in 2009 published a more comprehensive systematic review and cumulative analysis of studies up to 2008 comparing ORP, LRP, and RALP.18 Their literature search yielded 37 comparative studies, which included 23 (62%) comparing ORP with LRP, 10 (27%) comparing ORP with RALP, and four (11%) comparing LRP with RALP. Among these studies, there was only one randomized controlled trial (RCT) (level of evidence 1b), which compared ORP with LRP.19
ORP Versus LRP In 2006 Guazzoni et al conducted a prospective, randomized, single-surgeon study to compare intraand postoperative outcomes between ORP and LRP.19 A total of 120 consecutive age-matched patients with clinically localized prostate cancer were randomized to ORP (n ¼ 60) or LRP (n ¼ 60). Operative time was significantly shorter in ORP versus LRP patients (mean, 170 v 235 minutes; P o.001). However, LRP was associated with significantly lower blood loss than ORP (mean, 257.3 v 853.3 mL; P o.001) and transfusion rate (0% v 9%;
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P o.001). The LRP group also demonstrated earlier catheter removal and hospital discharge (P o.001). Postoperative pain was measured using a visual analog scale (VAS) at multiple time points; however, no significant differences were found between the two groups except on postoperative day 1. The 2009 review study from Ficarra et al18 reported findings consistent with the RCT by Guazzoni et al.19 Cumulative analysis of the published comparative studies found that operative time was significantly longer for LRP than ORP (weighted mean difference [WMD], 71.20 minutes; P o.00001). Similar to Guazzoni et al,19 Ficarra et al18 also found that blood loss (WMD, 557.43 mL) and transfusion rates (relative risk [RR], 4.72) were significantly lower in patients treated laparoscopically (both P o.0001). Again congruent with Guazzoni et al,19 cumulative analysis demonstrated that mean catheterization time (WMD, 6.18 days; P ¼ .03) and LOS (WMD, 2.46 days; P o.00001) were also significantly shorter for patients undergoing LRP compared with ORP.18 Lastly, the results of the cumulative analysis also favored LRP in terms of overall complications. The overall complication rate was significantly higher in patients undergoing ORP versus LRP (RR, 1.70; P ¼ .002). Considering only prospective studies, sensitivity analysis yielded similar results for all of the above-mentioned perioperative parameters.
ORP Versus RALP During the initial phase of the robotic learning curve, several studies documented significantly longer operative times for RALP versus ORP.6,20 In 2002, Menon et al reported a prospective nonrandomized comparison of 30 consecutive patients undergoing ORP and 30 initial patients undergoing RALP at the Vattikuti Institute.6 Mean operative time was significantly longer for RALP than ORP (4.8 hours v 2.3 hours; P o.001). Despite longer operative times, RALP had significantly less blood loss (mean, 329 mL v 970 mL), lower transfusion rates (6% v 31%), and earlier hospital discharge (each P o.001) even during the learning curve. However, differences in operative duration disappear with increasing robotic experience. Following their initial study,6 the authors from the Vattikuti Institute reported an updated prospective nonrandomized comparison of ORP (n ¼ 100) and RALP (n ¼ 200) in 2003.13 Comparable operative times were achieved in the two groups (ORP 163 minutes v. RALP 160 minutes; P 4.05). Similar to LRP, RALP demonstrated significantly less blood loss and lower transfusion rate than ORP.13,16 On cumulative analysis, Ficarra et al found that RALP was associated with a significantly lower transfusion rate (RR, 4.51;
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P ¼ .01).18 Only one study documented decreased mean urethral catheterization time for RALP versus ORP.13 Nearly all studies found decreased LOS in patients treated robotically. Conversely, Nelson et al reported a large prospective series of 1,003 radical prostatectomies (374 ORP, 629 RALP) from Vanderbilt University between January 2003 and March 2006 and found equivalent LOS between the two groups (ORP 1.17 v RAP 1.25 days, P ¼ .27).21 Using the same clinical pathway, the authors purported that the majority of patients undergoing RP can be discharged on postoperative day 1. Overall complication rates showed a nonstatistically significant trend in favor of RALP on cumulative analysis by Ficarra et al (RR, 1.22; P ¼ .44).18 However, cumulative analysis was not performed for mean operative time, blood loss, urethral catheterization time, and LOS due to differences in reporting outcomes between studies.
LRP Versus RALP Beyond the learning curve, comparative studies of LRP and RALP from highly skilled laparoscopic surgeons have demonstrated equivalence in several perioperative parameters.8,22 In 2007, Rozet et al from the Montsouris Institute compared their perioperative outcomes with RP using a pure laparoscopic versus robotically assisted technique in a matched-paired analysis of 266 patients (133 LRP, 133 RALP).22 No statistical differences between the two groups regarding operative time, blood loss, LOS, or duration of catheterization. Furthermore, major complications were equivalent (LRP 6% v RALP 6.8%, P ¼ .80). On cumulative analysis, Ficarra et al observed that both operative time (WMD, 19.39 minutes; P ¼ .58) and blood loss (WMD, 19.45 mL; P ¼ .96) were overlapping in LRP and RALP.18 Furthermore, only a non-statistically significant trend in favor of RALP was noted for transfusion rate (RR, 6.46; P ¼ .09). Both LOS and catheterization time were similar between the two groups, but again cumulative analysis was not possible because most studies did not provide data in the proper format.18 Conflicting results were reported with respect to complication rates. For example, Hu et al performed a retrospective comparison of 358 LRPs and 322 RALPs and reported lower complications among patients treated robotically.8 The authors attributed this to increasing surgeon experience with the recognition of laparoscopic anatomy rather than advantages inherent to robotics. On the other hand, Rozet et al reported significantly fewer overall complications among LRP versus RALP (9.1% v 19.4%; P ¼ .01).22 On cumulative analysis, Ficarra et al observed no differences between the two approaches in
K.A. Healy and L.G. Gomella
complication rates (RR, 1.83; P ¼ .16), even on sensitive analysis limited to prospective studies (RR, 1.0; P ¼ 1).18 Despite the widespread assumption that minimally invasive surgery is associated with less postoperative pain, Ficarra et al found that this parameter was not well addressed by the available comparative studies in 2009.18 Using a VAS, Tewari et al13 found a significant decrease in pain on postoperative day 1 among RALP versus ORP patients (VAS, 3 v 7; P o.05); however, it is unclear whether this benefit was maintained during the recovery period. Webster et al prospectively assessed postoperative pain in a cohort of RP patients using both the VAS and narcotic requirements.15 Narcotic use was low for both RALP and ORP patients. As such, there was no significant difference between the two groups. Although the investigators observed a statistically significant difference in pain scores in the immediate postoperative period favoring RALP (2.05 v 2.60; P ¼ .027), the clinical significance of this difference is questionable. Furthermore, equivalent pain scores were noted at postoperative day 1 (1.76 v 1.73; P ¼ 0.88) and day 14 (2.51 v 2.42, P ¼ .72). In summary, the cumulative analysis by Ficarra et al in 2009 showed that ORP was associated with shorter operative time, while LRP and RALP were similar.18 During the initial learning curve phase, differences in operative time are much greater between LRP and ORP. Compared to pure LRP, the learning curve for RALP is shorter, which leads to a quicker reduction in operative time. On cumulative analysis, the authors also found that both LRP and RALP have lower blood loss and transfusion rates than ORP. Significant variability was detected in catheterization time and LOS, which may be partly attributed to differences in clinical pathways, health care systems, and cultural practices. Despite this variability, an advantage was observed favoring LRP in the main comparative studies examined. A higher proportion of LRP and RALP patients had the catheter removed before the typical 7- to 10-day period used in many ORP series. In terms of overall complications, equivalent outcomes can be achieved for LRP and RALP compared to ORP once the learning curve is overcome. In addition to these systematic reviews by Ficarra et al,2,18 two large population-based studies evaluated the prevalence of complications in patients undergoing ORP or minimally invasive RP (MIRP).23,24 Of note, in both population studies MIRP included LRP as well as RALP, with the majority being robotic. Using a national 5% sample of Medicare beneficiaries from 2003 to 2005, Hu et al23 assessed outcomes among 2,702 men undergoing MIRP and ORP. After adjusting for several factors, including age, race, comorbidity, surgeon
Retropubic, laparoscopic, or robotic radical prostatectomy?
volume, and geographic region, MIRP was associated with fewer perioperative complications than ORP (odds radio [OR], 0.73; 95% confidence interval [CI], 0.60–0.90). In addition, MIRP was associated with significantly shorter LOS (parameter estimate, 2.99; 95% C -3.45 to -2.53). However, the odds of anastomotic stricture were higher among MIRP patients (OR, 1.40; 95% CI, 1.04–1.87). Notably, the risk of unfavorable outcomes such as stricture decreased with increasing MIRP surgical volume; that is, patients of high-volume MIRP surgeons experienced fewer anastomotic strictures (OR, 0.93; 95% CI, 0.87–0.99). Subsequently, this same group conducted a population-based observational cohort study of 8,837 men undergoing RP using Medicare linked Surveillance, Epidemiology, and End Results (SEER) data from 2003 through 2007.24 In this study, the investigators evaluated the comparative effectiveness of MIRP (n ¼ 1,938) versus ORP (n ¼ 6,899). Men undergoing MIRP differed significantly from those undergoing RRP in terms of demographic and tumor characteristics. Therefore, the investigators employed weighted propensity score adjustment to account for these confounding factors. Unadjusted analysis revealed comparable 30-day postoperative complications between MIRP and ORP (21.9% v 23.4%; P ¼ 0.31), which were most commonly classified as miscellaneous medical for both groups (9.4% v 8.7%). After propensity-score adjusted analysis, the overall 30-day complication rate remained equivalent between MIRP versus ORP (22.2% v 23.2%; P ¼ .58). However, MIRP versus ORP was associated with shorter LOS (median, 2.0 v 3.0 days; P o.001), lower transfusion rates (2.7% v 20.8%; P o.001), postoperative respiratory complications (4.3% v 6.6%; P ¼ .004), and miscellaneous surgical complications (4.3% v 5.6%, P ¼ .03). In contrast to their prior study, the authors found a lower anastomotic stricture rate with MIRP versus ORP (5.8% v 14.0%; P o.001). At the same time, MIRP was associated with an almost twofold increase in the odds of postoperative genitourinary complications than ORP (4.7% v 2.1%; P ¼ .001). The authors postulated that the differences in risk of anastomotic stricture between their two studies may be related to differences in the study populations. While the prior study examined a 5% random sample of Medicare beneficiaries nationwide, the 2009 JAMA study included 100% of Medicare beneficiaries in SEER registry areas. The majority of MIRPs were performed in California and Detroit, most likely at high-volume robotic centers. More recently, Trinh et al used the Nationwide Inpatient Sample between October 2008 and December 2009 to compare perioperative outcomes of RALP (n ¼ 11,889) with ORP (n ¼ 7,389).1
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Importantly, the robotic-assisted modifier was introduced in October 2008 and patients with the minimally invasive modifier code but without the robotic-assisted modifier were classified as having undergone LRP and thus excluded from the final analysis. Multivariate analysis of populations matched by propensity scores showed that RALP patients were less likely to receive a blood transfusion (OR, 0.34; 95% CI, 0.28–0.40) and less likely to experience an intraoperative complication (OR, 0.47; 95% CI, 0.31–0.71) or a postoperative complication (OR, 0.86; 95% CI, 0.77–0.96). Additionally, RALP patients were less likely to experience a prolonged LOS (OR, 0.28; 95% CI, 0.26–0.30). Based on these findings, Trinh et al concluded that RALP demonstrated superior perioperative outcomes for nearly all examined parameters. Caution is needed in interpreting this study as the National Inpatient Sample is limited to a single hospital admission and may not capture the true rate of complications from patients discharged and readmitted. Given the increasing use of RALP and expanding literature on perioperative outcomes, Novara et al25 in 2012 critically re-examined the literature and updated their two prior reviews.2,18 This group conducted a systematic review and meta-analysis of the RALP literature from 2008 to 2011 and evaluated complication rates, risk factors for complications, and surgical techniques to decrease the risk of complications. In this study, the authors also compared perioperative complications between ORP, LRP, and RALP. Analyzed parameters included operative time, blood loss, transfusion rate, catheterization time, and hospital LOS. During data acquisition, papers included into the two previously published reviews were excluded from the current study. Additional exclusion criteria included cases series with o100 patients and population-based studies, which are limited by inaccuracies of data collection and heterogeneity in surgical techniques. From the 110 selected papers, a total of 72 were included in the final analysis: 21 case series, 32 studies comparing different RALP techniques, 12 studies comparing RALP versus ORP, and seven studies comparing RALP versus LRP. Importantly, this included only five RCTs, which the authors noted may have been underpowered for accurate evaluation of complications. Table 1 summarizes perioperative outcomes for the RALP surgical series (n ¼ 21).25 Overall, the mean complication rate for RALP was 9% (range, 3%–26%), most of which were low grade. This included grade 1, 4% (2%–11.5%); grade 2, 3% (2%–9%); grade 3, 2% (0.5%–7%); grade 4, 0.4% (0%–1.5%); and grade 5, 0.02% (0%–0.5%). Lymphocele/lymphorrea (3.1%), urine leak (1.8%), and reoperation (1.6%) were the most common surgical
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Table 1. Perioperative Outcomes RALP (n ¼ 21 reported series)
After
Outcome
Mean
Range
Operative time (min) EBL (cc) Transfusion rate (%) Catheterization time (days) LOS (days)
152 166 2 6.3 1.9
90–291 6–534 0.5–5 5–8.6 1–6
Abbreviations. RALP, robotic-assisted laparoscopic prostatectomy; EBL, estimated blood loss; LOS, length of stay.
complications. As expected, patient characteristics such as high body mass index, large prostate volume, prior abdominal surgery, prior benign prostatic hyperplasia surgery, or presence of a median lobe made RALP more challenging and possibly increasing operative time, estimated blood loss, and duration of catheterization.26–36 Also as expected, surgical experience appears to impact perioperative outcomes. Zorn et al performed a prospective comparative study of 700 RALPs, which were divided into three consecutive groups (100–300, 301–500, 501–700).37 Both operative time and blood loss significantly improved over time. Ou et al reported consistent findings in a smaller series of 200 cases.38 Overall complications, minor complications, and major complications were significantly lower in the last 50 cases compared with the initial 150. Compared to ORP, RALP was associated with significantly less blood loss (WMD, 582.77; P o.00001) and need for transfusion (OR, 7.55; P o.00001) on cumulative analysis.25 However, operative time (WMD, 15.8; P ¼ .56) and overall complications (OR, 1.25; P ¼ .61) were similar for RALP and ORP. Meta-analysis was not possible for either LOS or catheterization time. Considering the same perioperative parameters, cumulative analysis was also performed to compare RALP with LRP. This showed that transfusion rate was significantly lower for RALP versus LRP (OR, 2.56; P ¼ .005). At the same time, operative time (WMD, 34.78; P ¼ .06), blood loss (WMD, 54.21; P ¼ .41), and overall complications (OR, 1.4; P ¼ .31) were equivalent for LRP and RALP. Again, meta-analysis was not possible for LOS of catheterization time. While several population-based studies have compared ORP with MIRP, it should be noted that these studies reported data from different years and using different data sets. Certainly there is heterogeneity in surgical technique and surgical experience. In addition, such population-based studies are limited by inaccuracies in data collection because outcomes are derived from diagnostic codes. According to the largest of these studies, the reported rates for overall
complications for MIRP ranged from 8%–20%. The rates for medical and surgical complications were 5%–9% and 1.4%–4.7%, respectively. Furthermore, the need for transfusion was reportedly as low as 2%. In contrast, the most recent systematic review by Novara et al in 201225 showed a lower overall complication rate (mean, 9%) and low prevalence of surgical complications, such as lymphocele, urine leak, or need for reoperation. Tewari et al in 201239 also conducted a systematic review and meta-analysis comparing ORP, LRP, and RALP series. They used propensity-score matching to adjust for differences in patient and tumor characteristics, such as preoperative prostate-specific antigen (PSA), preoperative Gleason score, and pathologic stage. Following propensity adjustment, the investigators found that overall intraoperative complications and postoperative complications were significantly lower for RALP compared to both LRP and ORP. Importantly, other covariates such as surgical proficiency or case load were not adjusted for in the analysis and may have affected outcomes.
PATIENT REPORTED OUTCOMES The majority of reports on outcomes are based on physician assessment of the specified outcome parameter. Studies suggest complications reported by patients may be higher than otherwise reported. For ORP patient historic self-reported incidence of postoperative impotence (82.2%) and incontinence (59.3%) were high but consistent with several published reports.40 Barry and associates conducted a more contemporary study comparing the risks of problems with continence and sexual function following ORP and RALP among Medicare-age men. Overall, 31% of men reported problems with continence and 88% problems with sexual function. Risks of problems with continence and sexual function are high after both procedures with a nonsignificant trend toward greater problems with continence. Their conclusion was that “Medicare-age men should not expect fewer adverse effects following robotic prostatectomy.”41
ONCOLOGIC OUTCOMES Among the surgical goals of the “radical prostatectomy trifecta,” oncologic control is of the highest priority. Due to the long natural history of clinically localized prostate cancer and the limited time of widespread application of RALP, data on long-term oncologic outcomes are lacking when benchmarked to ORP. Surrogates for cancer control include lymph node yield, surgical margins, and biochemical recurrence (BCR). Herein, we evaluate each of these surrogate end points more closely.
Retropubic, laparoscopic, or robotic radical prostatectomy?
In 2012, Novara et al surveyed the prostatectomy literature from 2008 through 2011 and reported a cumulative analysis of oncologic outcomes comparing RALP, LRP, and ORP.42 A total of 79 papers were retrieved evaluating oncologic outcomes after RALP. Overall, the mean positive surgical margin (PSM) rate was 15%, which varied depending on the extent of disease. Among those with pathologically localized disease, the PSM rate was 9%. Few data from highvolume centers reported follow-up of at least 5 years. Of those that did, the 7-year BCR-free survival was approximately 80%. Comparing the three surgical approaches, similar PSM rates and BCR-free survival were found. Specifically, cumulative analyses comparing RALP with LRP and RALP with ORP showed equivalent overall PSM rates (RALP v LRP OR ¼ 1.12, P ¼ .47; RALP v ORP OR ¼ 1.21, P ¼ .19), pT2 PSM rates (RALP v LRP OR ¼ 0.99, P ¼ .97; RALP v ORP OR ¼ 1.25, P ¼ .31), and BCR-free survival (RALP v LRP HR ¼ 0.5, P ¼ .141; RALP v ORP HR ¼ 0.9, P ¼ .526). Based on these findings, the authors concluded that PSM rates are similar regardless of the surgical approach. However, definitive conclusions on long-term outcomes such as cancer-specific mortality and BCR-free survival are not yet possible as the RALP data are still maturing.
Lymph Node Yield While the utility of pelvic lymphadenectomy (PLND) in low-risk prostate cancer remains debatable, it is considered a critical component of RP for those with intermediate- and high-risk disease. Several recent population-based studies have suggested that patients undergoing MIRP may be less likely to receive lymph node dissection than ORP patients. Using SEER-Medicare linked data, Abdollah et al examined the rate of PLND use and lymph node count (LNC) among 130,080 RPs between 1988 and 2006.43 During this time, an increasingly larger proportion of patients failed to undergo PLND and fewer lymph nodes were moved. Overall, stage pNx was recorded in 25.9% of patients, including 20.8% in 1988–1993 versus 30.1% in 2000–2006 (multivariate P o.001). Furthermore, the mean LNC decreased from 12 nodes in 1988 to 6.0 nodes in 2006 (median, 12 v 4, respectively). It remains unclear whether these temporal trends in LND practice patterns relate to the increasing use of RALP. Subsequently, Hu et al in 2011 also used the SEER registries to evaluate PLND practice patterns for men undergoing RP.44 Hu et al reported a large study of 5,448 men Z65 years undergoing ORP and MIRP from 2004–2006. Compared to ORP patients, those undergoing RALP were significantly less likely to receive PLND. PLND was performed for 87.6% versus 38.3% of men undergoing ORP versus MIRP
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(P o.01). In addition, patients undergoing RALP had lower lymph node yields. Both associations were independent of tumor characteristics. Perhaps these observed differences depend more on the surgeon rather than the surgical approach. Menon et al,45 Ham et al,36 and Feicke et al46 reported their external iliac, internal iliac, and obturator lymph node dissection yields at the time of RALP. Mean node count ranged from 12–19. Mean positive node rates varied between 11%–24%. Compared to a limited template, an extended template was associated with an increased risk of complications. Chung et al evaluated extraperitoneal versus transperitoneal limited lymphadenectomy and found comparable lymph node yields for the two approaches.47 However, as expected, extraperitoneal lymph node dissection was associated with a slightly higher risk of postoperative lymphocele (6% v 4%). In a retrospective review of 1,047 men undergoing RP at our cancer center (626 RALP and 427 ORP), lymph node yields and lymph node involvement for each surgical approach were calculated. Mean lymph node yield for the RALP cohort (7.1; interquartile range, 4–10) was significantly higher than for the ORP cohort (6.0; range, 3–8) (P o.001). However, the percentage of patients with nodal involvement was equivalent between the two groups (1.1 v 2.3; P ¼ 0.167). Therefore, PLND at the time of RALP was deemed feasible and comparable to the standard open approach with equivalent lymph node yields and PLND-related complications.48 In a similar study by Cooperberg et al of 1,278 patients (716 ORP and 562 RALP), node counts were slightly greater in the ORP group.49 In conclusion, lymphadenectomy is feasible at the time of RALP and appears to be similar in terms of nodal counts. At the same time, data suggest it is not routinely performed during RALP when clinically indicated for intermediate- or high-risk disease. This warrants further attention in future studies.
Surgical Margin Status PSMs are an independent predictor of biochemical and local recurrence, as well as the need for secondary treatment following RP.50 However, the impact of PSMs on cancer-specific and overall survival remains controversial. Nevertheless, surgical margin status is commonly used as a surrogate endpoint for oncologic control after RP. To date, oncologic outcomes evaluable for comparative series have been primarily limited to PSM status. In 2007 Ficarra et al conducted an initial review of the early RALP literature.2 A total of 71 manuscripts were identified, including five nonrandomized studies comparing ORP with RALP and three studies
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comparing RALP with LRP. Notably, most of the studies were considered poor-quality case-control studies or case series and thus rated as level 4 evidence. Only a minority were comparative studies, considered level 3b evidence. Moreover, most studies failed to describe the method of evaluation of the prostatectomy specimen sampling. As a result, it is difficult to compare PSM rates between different series. Among the series evaluated in Ficarra’s review, the overall PSM rates varied widely between 2%–59%. However, the rates were highly dependent on the pathologic tumor stage. After stratifying by stage, the PSM rates were 4.7%–27% in pT2 cancers and 26%–67% in pT3 cancers. Over time, Ficarra et al observed that increasing surgeon experience and improvements in surgical techniques yielded progressive decline in the PSM rates.2 In fact, early series demonstrated that PSM rates approached those of contemporary ORP and LRP series. While Menon et al reported a PSM rate of 15% in the first 100 RALPs,51 this decreased to only 4% in the last 100 cases.52 Similar reduction in PSM rates can be seen in the community setting as well. Patel et al demonstrated a reduction in PSM from 13% in the initial 100 cases to 8% in the following 100 cases.12 Consistent with these findings, Ahlering and associates reported decreased PSMs in pT2 cases from 27% in the first 50 cases to 4.7% in the subsequent 90 cases.53 In addition to increasing experience, Ahlering et al employed modifications in the apical dissection, which may account for part of the improvements in their PSM rates. Given the lack of long-term follow-up, Ficarra et al in 2007 could not draw any definitive conclusions regarding oncologic outcomes after RALP.2 Beyond observing that PSM rates were similar for RALP, LRP, and ORP, other outcomes of interest such as biochemical recurrence and cancer-specific survival were only preliminary. Subsequently in 2009, Ficarra et al conducted another review of prostatectomy outcomes including oncologic endpoints, which were predominantly limited to PSM rates for MIRP.18 In a prospective, randomized single-surgeon study of 120 patients, Guazzoni et al in 2006 reported similar PSM rates for ORP and LRP (21.6% v 26%; P ¼ .28), even when stratifying by pathologic stage. Consistent with these findings, the majority of nonrandomized prospective studies comparing RRP and LRP reported similar results.18 Cumulative analysis of all comparative studies demonstrated overlapping PSM rates in ORP and LRP (RR, 1.08; 95% CI of RR, 0.97–1.19; P ¼ .17). Sensitivity analysis limited to only pT2 cancers confirmed no significant differences in PSM rates between ORP and LRP (RR, 1.02; 95% CI of RR, 0.83–1.26; P ¼ .85). Considering non-comparative studies evaluating surgical margin status, Ficarra et al
K.A. Healy and L.G. Gomella
in 2009 found PSM rates ranging from 11%–37% after ORP, from 11%–30% after LRP, and from 9.6%–26% after RALP. Among the studies included in Ficarra’s review in 2009, the largest prospective study found lower overall PSM rates in those patients treated by RALP than ORP.13 In this study of 200 patients undergoing RALP and 100 undergoing ORP, PSM was more frequent after ORP (23% v 9%; P o.05) and importantly pathological stages were comparable. Similar results favoring RALP were reported by Smith and colleagues in their retrospective study of 200 ORP patients versus 200 RALP patients with PSM rates of 35% versus 15%, respectively (P o.001).54 Among patients with pT2 prostate cancer, these differences remained statistically significant (ORP 24.1% v RALP 9.4%; P o.001). Cumulative analysis of comparative studies of overall PSM rates revealed a statistically significant advantage for RALP over ORP (RR, 1.58; 95% CI of RR, 1.29–1.94, P o.00001).18 Likewise, sensitivity analysis limited to prospective studies confirmed a significantly lower risk of PSM for RALP than ORP (RR, 1.90; 95% CI of RR, 1.24–2.89; P ¼ .003). Furthermore, on sensitivity analysis limited to pathologically localized cancers, the incidence of PSM remained significantly lower among RALP compared to ORP patients (RR, 2.23; 95% of CI RR, 1.36– 3.67; P ¼ .002). Lastly, Ficarra et al found no statistically significant difference in the PSM rate on cumulative analysis comparing LRP and RALP (RR, 0.97; 95% CI of RR, 0.65–1.46; P ¼ .9). Sensitivity analysis limited to pT2 cancers confirmed this PSM rate equivalence for these two minimally invasive approaches (RR, 0.74; 95% CI of RR, 0.42–1.33; P ¼ .31). Based on RALP series from 2008 and 2011, Novara et al found an overall mean PSM rate of 15% (range, 6.5%–32%).42 Importantly, however, Novara et al noted that many series failed to describe the pathologic protocol for sampling the RALP specimens, which affects the PSM rate. As expected, the PSM rates are highly stage-dependent. After stratifying by pathologic tumor stage, the mean PSM rate was 9% (4%–23%) in pT2, 37% (29%–50%) in pT3, and 50% (40%–75%) in pT4 disease. Considering the location of the PSM, the most common site was the prostatic apex in 5% (1%–7%), postero-laterally in 2.6% (2%– 21%), and anteriorly in 0.6% (1%–2%). Multifocal PSMs were present in 2.2% (2%–9%) of RALP cases. Based on comparative studies evaluating ORP and RALP, cumulative analysis demonstrated only nonstatistically significant differences in overall PSM rates (21% v 20%; OR, 1.21; P ¼ .19). Among pT2 cancers, PSM rates were also similar following ORP and RALP (12% v 11%; OR, 1.25; P ¼ .31). Comparing LRP and RALP, overall PSM rates (18% v 18%; OR, 1.12; P ¼ .47) as well as PSM rates in pT2 cancers
Retropubic, laparoscopic, or robotic radical prostatectomy?
(11% v 12%; OR, 0.99; P ¼ .97) were equivalent. Taken together, Novara et al found that no surgical approach demonstrated superiority from a PSM standpoint. Rather, tumor characteristics such as PSA, pathologic stage, Gleason score, and prostate volume appear to be the most relevant predictors of PSM. Importantly, this most recent cumulative analysis in 201242 by Novara’s group failed to reconfirm the advantages of RALP in terms of PSM rates that were previously reported in their 2009 analysis.18 The incidences of PSMs found reported in Novara and colleagues’ analysis are consistent with those of a recent large multicenter collaboration by Patel et al, which included 8,418 patients who underwent RALP from seven institutions.55 The overall PSM rate was 15.7% (1,272 of 8,095 patients). Based on pathological stage, the PSM rates for pT2 and pT3 disease were 9.45% and 37.2%, respectively. Multivariate analysis showed that pathological stage (pT2 v pT3 OR ¼ 4.588; P o.001) and preoperative PSA (r4 v 410 ng/mL; OR, 2.918; P o.001) were the most important predictors of PSMs after RALP. Again, predictors of PSM rates in RALP series are congruent with the prior ORP literature. Several studies have assessed the impact of different modifications in RALP technique on PSM rates. Basically, technical details in every step of the procedure have been evaluated, such as trans- versus extra-peritoneal, bladder neck preservation, and extra- versus inter-fascial neurovascular bundle (NVB) dissection. In particular, three studies examined the effect of different techniques for control of the dorsal venous complex (DVC) on PSMs. Compared to DVC incision following ligation, Guru and colleagues found that incision without ligation was associated with significant decreased risk of apical PSMS (2% v 8%; P ¼ .02).56 Conversely, Lei et al failed to demonstrate any statistically significant difference between athermal division and selective suturing of the DVC versus nonselective suture ligation and athermal division in terms of overall PSMs (12% v 12%; P ¼ 1) or apical PSMs (1% v 3%; P ¼ 0.361).57 However, athermal division and selective suturing was associated with significantly higher early urinary continence. Lastly, Wu et al compared staple v suture ligation of the DVC during RALP and found that staple ligation was associated with lower overall PSMs (6% v 18%; P ¼ .02) as well as apical PSMs (2% v 13%; P ¼ .005).58 Recently Tewari et al employed propensity adjustment in their systematic review and meta-analysis and reported overall PSM rates of 24.2% ORP, 20.4% LRP, and 16.2% RALP.39 For pT2 cancers, PSM rates were 16.6% ORP, 13.0% LRP, and 10.7% RALP. After propensity-score matching, RALP was significantly better than LRP for both overall and pT2 PSM rates (overall PSM P ¼ .002; pT2 PSM P ¼.01). On the
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other hand, ORP and RALP were found to be equivalent for both comparisons.
Biochemical Recurrence Considering BCR in RALP series from 2008 to 2011,42 two studies reported outcomes with at least 5-year follow-up data.59,60 Menon et al in 2010 evaluated BCR after RALP in 1,384 patients treated at the Vattikuti Urology Institute with a median follow-up of 60.2 months.59 Using a PSA cutoff Z.2 ng/mL, the reported BCR-free survival rates were 90.6%, 86.6%, and 81.0% at 3, 5, and 7 years, respectively. Median time to BCR was 20.4 months. On multivariate analysis, the strongest predictors of BCR were pathologic Gleason grade 8–10 (HR, 5.37; 95% CI, 2.99–9.65; P o.0001) and pathologic stage T3b/4 (HR, 2.71; 95% CI, 1.67–4.40; P o.0001). In a smaller series of 184 patients with Z5 year followup, Suardi et al in 2012 reported similar BCR outcomes again defining BCR as PSA Z0.2 ng/mL.60 Median follow-up was 67.5 months. The 3-, 5-, and 7-year BCR-free survival rates were 94%, 86%, and 81%, respectively, and the mean time to BCR was 83.8 months. Multivariate analysis demonstrated that the presence of seminal vesicle invasion (HR, 5.14; P ¼ .004) and Gleason sum 8–10 (HR, 3.04; P ¼ .04) were independent predictors of BCR. Based on these studies, RALP appears to confer effective 5-year biochemical control for the treatment of organconfined prostate cancer. Among comparative studies of ORP, LRP, and RALP, Novara et al reported no significant differences in BCR-free survival estimates between ORP and RALP (HR, 0.9; 95% CI, 0.7–1.2, P ¼ .526) or between LRP and RALP (HR, 0.5; 95% CI, 0.2–1.3; P ¼ .141).42 Regardless of the surgical approach, BCR rates were found to be equivalent. Data are limited on the need for adjuvant therapy following RALP either based on BCR or PSM. Among RALP series published between 2008 and 2011,42 the reported use of adjuvant therapies varied widely between 0.5%–23%, (mean, 4%). Therefore, comparative analysis on surgical approaches is not yet feasible.
CONCLUSIONS ORP and RALP remain as acceptable treatments for localized prostate cancer. Although RALP has proven itself as an acceptable alternative to ORP with reasonable risk of complications, it has not been shown to be convincingly superior to ORP. Compared with ORP and LRP, RALP was consistently associated with less blood loss and lower transfusion rates with higher costs. In addition to surgical approach, patient factors and surgeon experience
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likely impact perioperative outcomes but can be hard to capture in these comparative analyses. Commentaries often cite that surgical experience may be more critical than the use of one technique over the other.61 Considerable disparities in measurement and reporting practices of perioperative outcomes continue to make direct comparisons difficult. Future prospective studies of RP perioperative outcomes should aim to use rigorous methodology and established criteria for standardized reporting.
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13.
14.
15.
16.
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patients with a minimum follow-up of 5 years. Urology. 2012;79:133–8. 61. Cooperberg M, Odisho A, Carroll P. The association of robotic surgical technology and hospital prostatectomy volumes: increasing market share through the adoption of technology. J Clin Oncol. 2012;118: 371–7.
A
ccording to data from the nationwide inpatient sample in 2009 robotic-assisted laparoscopic radical prostatectomy (RALP) has supplanted open radical retropubic prostatectomy (ORP) as the most common surgical approach for radical prostatectomy (RP), accounting for 61% of cases reported.1 There is an overall impression that minimally invasive techniques such as laparoscopic radical prostatectomy (LRP) and RALP are convincingly superior to the traditional ORP techniques. We reviewed the existing literature with attention to the perioperative outcomes and oncologic outcomes reported comparing the newer laparoscopic techniques with existing ORP data in the management of localized prostate cancer.
PERIOPERATIVE OUTCOMES In an initial systematic review of the RALP literature until 2007, Ficarra et al noted a complication Department of Urology, Kimmel Cancer Center, Thomas Jefferson University Philadelphia, PA. Conflicts of interest: none. Address correspondence to Leonard G. Gomella, MD, Room 1102, 1025 Walnut St, Philadelphia, PA 19107. E-mail: leonard.gomella@jefferson. edu 0270-9295/ - see front matter & 2013 Published by Elsevier Inc. http://dx.doi.org/10.1053/j.seminoncol.2013.04.004
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rate ranging from 1.5%–20%.2 Importantly, most studies included in the review were case series or poor-quality case-control studies and therefore rated as level 4 evidence. In addition, these studies also represent the first reports published in the literature. As the surgeon’s experience increases, the operative time for RALP decreases significantly.3–5 During the learning curve phase, perioperative complications varied widely from 1%–42%.2 Operative times for the first 40 RALPs performed at the Vattikuti Institute during their structured training program compared favorably to those for LRP done by Guillonneau and Vallancien, two experienced French laparoscopists.4 In addition, RALP was associated with a significantly lower blood loss. Comparative studies from Menon et al of the first RALPs versus ORPs demonstrated that the robotic approach may require longer operative times but yields decreased blood loss, decreased blood transfusion, and less postoperative pain, as well as earlier hospital discharge.6 In this same review, Ficarra et al examined postoperative outcomes from mature RALP clinical series beyond the learning curve. Overall complication rates ranged between 1.5%–16%.2 All evaluated series reported minimal blood loss, with transfusion rates between 0%–12%. Less consistent was the duration of hospitalization, which is likely highly dependent on institutional practices, clinical pathways, and the Seminars in Oncology, Vol 40, No 3, June 2013, pp 286-296
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larger health care system. After overcoming the learning curve, mean operating times can be reduced to 180 minutes (range, 81–365).7 Similar results can be obtained using either an extraperitoneal or transperitoneal approach.8–11 Furthermore, equivalent operative times can be achieved in academic and community settings.12 Early comparative series of RALP and ORP have yielded conflicting results. Tewari et al compared the first 200 RALPs with 100 consecutive contemporary ORPs and found that operative times are similar once beyond the learning curve.13 The study also confirmed the benefits of the robotic-assisted approach, including decreased blood loss, transfusion rate, postoperative pain, and hospital stay. Ahlering et al reported similar findings in their institutional comparison of the last 60 RALPs from June 2003 to August 2004 to the last 60 ORPs in 2001 and 2002.14 On the other hand, Webster et al compared perioperative outcomes for 159 RALPs and 154 ORPs. The authors failed to find any significant improvements in postoperative pain15 or transfusion16 between the two approaches. Comparing RALP and LRP, two studies found no differences in operative times, transfusions, and postoperative complications.17,18 Based on this review of early studies, Ficarra et al concluded that RALP appears to be a feasible procedure with limited blood loss, favorable complication rates, and short hospital length of stay (LOS). Despite these initial experiences, the limited number of patients and lack of highquality data included in the review did not allow for definitive conclusions on perioperative outcomes. Following this initial RALP 2007 review, Ficarra et al in 2009 published a more comprehensive systematic review and cumulative analysis of studies up to 2008 comparing ORP, LRP, and RALP.18 Their literature search yielded 37 comparative studies, which included 23 (62%) comparing ORP with LRP, 10 (27%) comparing ORP with RALP, and four (11%) comparing LRP with RALP. Among these studies, there was only one randomized controlled trial (RCT) (level of evidence 1b), which compared ORP with LRP.19
ORP Versus LRP In 2006 Guazzoni et al conducted a prospective, randomized, single-surgeon study to compare intraand postoperative outcomes between ORP and LRP.19 A total of 120 consecutive age-matched patients with clinically localized prostate cancer were randomized to ORP (n ¼ 60) or LRP (n ¼ 60). Operative time was significantly shorter in ORP versus LRP patients (mean, 170 v 235 minutes; P o.001). However, LRP was associated with significantly lower blood loss than ORP (mean, 257.3 v 853.3 mL; P o.001) and transfusion rate (0% v 9%;
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P o.001). The LRP group also demonstrated earlier catheter removal and hospital discharge (P o.001). Postoperative pain was measured using a visual analog scale (VAS) at multiple time points; however, no significant differences were found between the two groups except on postoperative day 1. The 2009 review study from Ficarra et al18 reported findings consistent with the RCT by Guazzoni et al.19 Cumulative analysis of the published comparative studies found that operative time was significantly longer for LRP than ORP (weighted mean difference [WMD], 71.20 minutes; P o.00001). Similar to Guazzoni et al,19 Ficarra et al18 also found that blood loss (WMD, 557.43 mL) and transfusion rates (relative risk [RR], 4.72) were significantly lower in patients treated laparoscopically (both P o.0001). Again congruent with Guazzoni et al,19 cumulative analysis demonstrated that mean catheterization time (WMD, 6.18 days; P ¼ .03) and LOS (WMD, 2.46 days; P o.00001) were also significantly shorter for patients undergoing LRP compared with ORP.18 Lastly, the results of the cumulative analysis also favored LRP in terms of overall complications. The overall complication rate was significantly higher in patients undergoing ORP versus LRP (RR, 1.70; P ¼ .002). Considering only prospective studies, sensitivity analysis yielded similar results for all of the above-mentioned perioperative parameters.
ORP Versus RALP During the initial phase of the robotic learning curve, several studies documented significantly longer operative times for RALP versus ORP.6,20 In 2002, Menon et al reported a prospective nonrandomized comparison of 30 consecutive patients undergoing ORP and 30 initial patients undergoing RALP at the Vattikuti Institute.6 Mean operative time was significantly longer for RALP than ORP (4.8 hours v 2.3 hours; P o.001). Despite longer operative times, RALP had significantly less blood loss (mean, 329 mL v 970 mL), lower transfusion rates (6% v 31%), and earlier hospital discharge (each P o.001) even during the learning curve. However, differences in operative duration disappear with increasing robotic experience. Following their initial study,6 the authors from the Vattikuti Institute reported an updated prospective nonrandomized comparison of ORP (n ¼ 100) and RALP (n ¼ 200) in 2003.13 Comparable operative times were achieved in the two groups (ORP 163 minutes v. RALP 160 minutes; P 4.05). Similar to LRP, RALP demonstrated significantly less blood loss and lower transfusion rate than ORP.13,16 On cumulative analysis, Ficarra et al found that RALP was associated with a significantly lower transfusion rate (RR, 4.51;
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P ¼ .01).18 Only one study documented decreased mean urethral catheterization time for RALP versus ORP.13 Nearly all studies found decreased LOS in patients treated robotically. Conversely, Nelson et al reported a large prospective series of 1,003 radical prostatectomies (374 ORP, 629 RALP) from Vanderbilt University between January 2003 and March 2006 and found equivalent LOS between the two groups (ORP 1.17 v RAP 1.25 days, P ¼ .27).21 Using the same clinical pathway, the authors purported that the majority of patients undergoing RP can be discharged on postoperative day 1. Overall complication rates showed a nonstatistically significant trend in favor of RALP on cumulative analysis by Ficarra et al (RR, 1.22; P ¼ .44).18 However, cumulative analysis was not performed for mean operative time, blood loss, urethral catheterization time, and LOS due to differences in reporting outcomes between studies.
LRP Versus RALP Beyond the learning curve, comparative studies of LRP and RALP from highly skilled laparoscopic surgeons have demonstrated equivalence in several perioperative parameters.8,22 In 2007, Rozet et al from the Montsouris Institute compared their perioperative outcomes with RP using a pure laparoscopic versus robotically assisted technique in a matched-paired analysis of 266 patients (133 LRP, 133 RALP).22 No statistical differences between the two groups regarding operative time, blood loss, LOS, or duration of catheterization. Furthermore, major complications were equivalent (LRP 6% v RALP 6.8%, P ¼ .80). On cumulative analysis, Ficarra et al observed that both operative time (WMD, 19.39 minutes; P ¼ .58) and blood loss (WMD, 19.45 mL; P ¼ .96) were overlapping in LRP and RALP.18 Furthermore, only a non-statistically significant trend in favor of RALP was noted for transfusion rate (RR, 6.46; P ¼ .09). Both LOS and catheterization time were similar between the two groups, but again cumulative analysis was not possible because most studies did not provide data in the proper format.18 Conflicting results were reported with respect to complication rates. For example, Hu et al performed a retrospective comparison of 358 LRPs and 322 RALPs and reported lower complications among patients treated robotically.8 The authors attributed this to increasing surgeon experience with the recognition of laparoscopic anatomy rather than advantages inherent to robotics. On the other hand, Rozet et al reported significantly fewer overall complications among LRP versus RALP (9.1% v 19.4%; P ¼ .01).22 On cumulative analysis, Ficarra et al observed no differences between the two approaches in
K.A. Healy and L.G. Gomella
complication rates (RR, 1.83; P ¼ .16), even on sensitive analysis limited to prospective studies (RR, 1.0; P ¼ 1).18 Despite the widespread assumption that minimally invasive surgery is associated with less postoperative pain, Ficarra et al found that this parameter was not well addressed by the available comparative studies in 2009.18 Using a VAS, Tewari et al13 found a significant decrease in pain on postoperative day 1 among RALP versus ORP patients (VAS, 3 v 7; P o.05); however, it is unclear whether this benefit was maintained during the recovery period. Webster et al prospectively assessed postoperative pain in a cohort of RP patients using both the VAS and narcotic requirements.15 Narcotic use was low for both RALP and ORP patients. As such, there was no significant difference between the two groups. Although the investigators observed a statistically significant difference in pain scores in the immediate postoperative period favoring RALP (2.05 v 2.60; P ¼ .027), the clinical significance of this difference is questionable. Furthermore, equivalent pain scores were noted at postoperative day 1 (1.76 v 1.73; P ¼ 0.88) and day 14 (2.51 v 2.42, P ¼ .72). In summary, the cumulative analysis by Ficarra et al in 2009 showed that ORP was associated with shorter operative time, while LRP and RALP were similar.18 During the initial learning curve phase, differences in operative time are much greater between LRP and ORP. Compared to pure LRP, the learning curve for RALP is shorter, which leads to a quicker reduction in operative time. On cumulative analysis, the authors also found that both LRP and RALP have lower blood loss and transfusion rates than ORP. Significant variability was detected in catheterization time and LOS, which may be partly attributed to differences in clinical pathways, health care systems, and cultural practices. Despite this variability, an advantage was observed favoring LRP in the main comparative studies examined. A higher proportion of LRP and RALP patients had the catheter removed before the typical 7- to 10-day period used in many ORP series. In terms of overall complications, equivalent outcomes can be achieved for LRP and RALP compared to ORP once the learning curve is overcome. In addition to these systematic reviews by Ficarra et al,2,18 two large population-based studies evaluated the prevalence of complications in patients undergoing ORP or minimally invasive RP (MIRP).23,24 Of note, in both population studies MIRP included LRP as well as RALP, with the majority being robotic. Using a national 5% sample of Medicare beneficiaries from 2003 to 2005, Hu et al23 assessed outcomes among 2,702 men undergoing MIRP and ORP. After adjusting for several factors, including age, race, comorbidity, surgeon
Retropubic, laparoscopic, or robotic radical prostatectomy?
volume, and geographic region, MIRP was associated with fewer perioperative complications than ORP (odds radio [OR], 0.73; 95% confidence interval [CI], 0.60–0.90). In addition, MIRP was associated with significantly shorter LOS (parameter estimate, 2.99; 95% C -3.45 to -2.53). However, the odds of anastomotic stricture were higher among MIRP patients (OR, 1.40; 95% CI, 1.04–1.87). Notably, the risk of unfavorable outcomes such as stricture decreased with increasing MIRP surgical volume; that is, patients of high-volume MIRP surgeons experienced fewer anastomotic strictures (OR, 0.93; 95% CI, 0.87–0.99). Subsequently, this same group conducted a population-based observational cohort study of 8,837 men undergoing RP using Medicare linked Surveillance, Epidemiology, and End Results (SEER) data from 2003 through 2007.24 In this study, the investigators evaluated the comparative effectiveness of MIRP (n ¼ 1,938) versus ORP (n ¼ 6,899). Men undergoing MIRP differed significantly from those undergoing RRP in terms of demographic and tumor characteristics. Therefore, the investigators employed weighted propensity score adjustment to account for these confounding factors. Unadjusted analysis revealed comparable 30-day postoperative complications between MIRP and ORP (21.9% v 23.4%; P ¼ 0.31), which were most commonly classified as miscellaneous medical for both groups (9.4% v 8.7%). After propensity-score adjusted analysis, the overall 30-day complication rate remained equivalent between MIRP versus ORP (22.2% v 23.2%; P ¼ .58). However, MIRP versus ORP was associated with shorter LOS (median, 2.0 v 3.0 days; P o.001), lower transfusion rates (2.7% v 20.8%; P o.001), postoperative respiratory complications (4.3% v 6.6%; P ¼ .004), and miscellaneous surgical complications (4.3% v 5.6%, P ¼ .03). In contrast to their prior study, the authors found a lower anastomotic stricture rate with MIRP versus ORP (5.8% v 14.0%; P o.001). At the same time, MIRP was associated with an almost twofold increase in the odds of postoperative genitourinary complications than ORP (4.7% v 2.1%; P ¼ .001). The authors postulated that the differences in risk of anastomotic stricture between their two studies may be related to differences in the study populations. While the prior study examined a 5% random sample of Medicare beneficiaries nationwide, the 2009 JAMA study included 100% of Medicare beneficiaries in SEER registry areas. The majority of MIRPs were performed in California and Detroit, most likely at high-volume robotic centers. More recently, Trinh et al used the Nationwide Inpatient Sample between October 2008 and December 2009 to compare perioperative outcomes of RALP (n ¼ 11,889) with ORP (n ¼ 7,389).1
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Importantly, the robotic-assisted modifier was introduced in October 2008 and patients with the minimally invasive modifier code but without the robotic-assisted modifier were classified as having undergone LRP and thus excluded from the final analysis. Multivariate analysis of populations matched by propensity scores showed that RALP patients were less likely to receive a blood transfusion (OR, 0.34; 95% CI, 0.28–0.40) and less likely to experience an intraoperative complication (OR, 0.47; 95% CI, 0.31–0.71) or a postoperative complication (OR, 0.86; 95% CI, 0.77–0.96). Additionally, RALP patients were less likely to experience a prolonged LOS (OR, 0.28; 95% CI, 0.26–0.30). Based on these findings, Trinh et al concluded that RALP demonstrated superior perioperative outcomes for nearly all examined parameters. Caution is needed in interpreting this study as the National Inpatient Sample is limited to a single hospital admission and may not capture the true rate of complications from patients discharged and readmitted. Given the increasing use of RALP and expanding literature on perioperative outcomes, Novara et al25 in 2012 critically re-examined the literature and updated their two prior reviews.2,18 This group conducted a systematic review and meta-analysis of the RALP literature from 2008 to 2011 and evaluated complication rates, risk factors for complications, and surgical techniques to decrease the risk of complications. In this study, the authors also compared perioperative complications between ORP, LRP, and RALP. Analyzed parameters included operative time, blood loss, transfusion rate, catheterization time, and hospital LOS. During data acquisition, papers included into the two previously published reviews were excluded from the current study. Additional exclusion criteria included cases series with o100 patients and population-based studies, which are limited by inaccuracies of data collection and heterogeneity in surgical techniques. From the 110 selected papers, a total of 72 were included in the final analysis: 21 case series, 32 studies comparing different RALP techniques, 12 studies comparing RALP versus ORP, and seven studies comparing RALP versus LRP. Importantly, this included only five RCTs, which the authors noted may have been underpowered for accurate evaluation of complications. Table 1 summarizes perioperative outcomes for the RALP surgical series (n ¼ 21).25 Overall, the mean complication rate for RALP was 9% (range, 3%–26%), most of which were low grade. This included grade 1, 4% (2%–11.5%); grade 2, 3% (2%–9%); grade 3, 2% (0.5%–7%); grade 4, 0.4% (0%–1.5%); and grade 5, 0.02% (0%–0.5%). Lymphocele/lymphorrea (3.1%), urine leak (1.8%), and reoperation (1.6%) were the most common surgical
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Table 1. Perioperative Outcomes RALP (n ¼ 21 reported series)
After
Outcome
Mean
Range
Operative time (min) EBL (cc) Transfusion rate (%) Catheterization time (days) LOS (days)
152 166 2 6.3 1.9
90–291 6–534 0.5–5 5–8.6 1–6
Abbreviations. RALP, robotic-assisted laparoscopic prostatectomy; EBL, estimated blood loss; LOS, length of stay.
complications. As expected, patient characteristics such as high body mass index, large prostate volume, prior abdominal surgery, prior benign prostatic hyperplasia surgery, or presence of a median lobe made RALP more challenging and possibly increasing operative time, estimated blood loss, and duration of catheterization.26–36 Also as expected, surgical experience appears to impact perioperative outcomes. Zorn et al performed a prospective comparative study of 700 RALPs, which were divided into three consecutive groups (100–300, 301–500, 501–700).37 Both operative time and blood loss significantly improved over time. Ou et al reported consistent findings in a smaller series of 200 cases.38 Overall complications, minor complications, and major complications were significantly lower in the last 50 cases compared with the initial 150. Compared to ORP, RALP was associated with significantly less blood loss (WMD, 582.77; P o.00001) and need for transfusion (OR, 7.55; P o.00001) on cumulative analysis.25 However, operative time (WMD, 15.8; P ¼ .56) and overall complications (OR, 1.25; P ¼ .61) were similar for RALP and ORP. Meta-analysis was not possible for either LOS or catheterization time. Considering the same perioperative parameters, cumulative analysis was also performed to compare RALP with LRP. This showed that transfusion rate was significantly lower for RALP versus LRP (OR, 2.56; P ¼ .005). At the same time, operative time (WMD, 34.78; P ¼ .06), blood loss (WMD, 54.21; P ¼ .41), and overall complications (OR, 1.4; P ¼ .31) were equivalent for LRP and RALP. Again, meta-analysis was not possible for LOS of catheterization time. While several population-based studies have compared ORP with MIRP, it should be noted that these studies reported data from different years and using different data sets. Certainly there is heterogeneity in surgical technique and surgical experience. In addition, such population-based studies are limited by inaccuracies in data collection because outcomes are derived from diagnostic codes. According to the largest of these studies, the reported rates for overall
complications for MIRP ranged from 8%–20%. The rates for medical and surgical complications were 5%–9% and 1.4%–4.7%, respectively. Furthermore, the need for transfusion was reportedly as low as 2%. In contrast, the most recent systematic review by Novara et al in 201225 showed a lower overall complication rate (mean, 9%) and low prevalence of surgical complications, such as lymphocele, urine leak, or need for reoperation. Tewari et al in 201239 also conducted a systematic review and meta-analysis comparing ORP, LRP, and RALP series. They used propensity-score matching to adjust for differences in patient and tumor characteristics, such as preoperative prostate-specific antigen (PSA), preoperative Gleason score, and pathologic stage. Following propensity adjustment, the investigators found that overall intraoperative complications and postoperative complications were significantly lower for RALP compared to both LRP and ORP. Importantly, other covariates such as surgical proficiency or case load were not adjusted for in the analysis and may have affected outcomes.
PATIENT REPORTED OUTCOMES The majority of reports on outcomes are based on physician assessment of the specified outcome parameter. Studies suggest complications reported by patients may be higher than otherwise reported. For ORP patient historic self-reported incidence of postoperative impotence (82.2%) and incontinence (59.3%) were high but consistent with several published reports.40 Barry and associates conducted a more contemporary study comparing the risks of problems with continence and sexual function following ORP and RALP among Medicare-age men. Overall, 31% of men reported problems with continence and 88% problems with sexual function. Risks of problems with continence and sexual function are high after both procedures with a nonsignificant trend toward greater problems with continence. Their conclusion was that “Medicare-age men should not expect fewer adverse effects following robotic prostatectomy.”41
ONCOLOGIC OUTCOMES Among the surgical goals of the “radical prostatectomy trifecta,” oncologic control is of the highest priority. Due to the long natural history of clinically localized prostate cancer and the limited time of widespread application of RALP, data on long-term oncologic outcomes are lacking when benchmarked to ORP. Surrogates for cancer control include lymph node yield, surgical margins, and biochemical recurrence (BCR). Herein, we evaluate each of these surrogate end points more closely.
Retropubic, laparoscopic, or robotic radical prostatectomy?
In 2012, Novara et al surveyed the prostatectomy literature from 2008 through 2011 and reported a cumulative analysis of oncologic outcomes comparing RALP, LRP, and ORP.42 A total of 79 papers were retrieved evaluating oncologic outcomes after RALP. Overall, the mean positive surgical margin (PSM) rate was 15%, which varied depending on the extent of disease. Among those with pathologically localized disease, the PSM rate was 9%. Few data from highvolume centers reported follow-up of at least 5 years. Of those that did, the 7-year BCR-free survival was approximately 80%. Comparing the three surgical approaches, similar PSM rates and BCR-free survival were found. Specifically, cumulative analyses comparing RALP with LRP and RALP with ORP showed equivalent overall PSM rates (RALP v LRP OR ¼ 1.12, P ¼ .47; RALP v ORP OR ¼ 1.21, P ¼ .19), pT2 PSM rates (RALP v LRP OR ¼ 0.99, P ¼ .97; RALP v ORP OR ¼ 1.25, P ¼ .31), and BCR-free survival (RALP v LRP HR ¼ 0.5, P ¼ .141; RALP v ORP HR ¼ 0.9, P ¼ .526). Based on these findings, the authors concluded that PSM rates are similar regardless of the surgical approach. However, definitive conclusions on long-term outcomes such as cancer-specific mortality and BCR-free survival are not yet possible as the RALP data are still maturing.
Lymph Node Yield While the utility of pelvic lymphadenectomy (PLND) in low-risk prostate cancer remains debatable, it is considered a critical component of RP for those with intermediate- and high-risk disease. Several recent population-based studies have suggested that patients undergoing MIRP may be less likely to receive lymph node dissection than ORP patients. Using SEER-Medicare linked data, Abdollah et al examined the rate of PLND use and lymph node count (LNC) among 130,080 RPs between 1988 and 2006.43 During this time, an increasingly larger proportion of patients failed to undergo PLND and fewer lymph nodes were moved. Overall, stage pNx was recorded in 25.9% of patients, including 20.8% in 1988–1993 versus 30.1% in 2000–2006 (multivariate P o.001). Furthermore, the mean LNC decreased from 12 nodes in 1988 to 6.0 nodes in 2006 (median, 12 v 4, respectively). It remains unclear whether these temporal trends in LND practice patterns relate to the increasing use of RALP. Subsequently, Hu et al in 2011 also used the SEER registries to evaluate PLND practice patterns for men undergoing RP.44 Hu et al reported a large study of 5,448 men Z65 years undergoing ORP and MIRP from 2004–2006. Compared to ORP patients, those undergoing RALP were significantly less likely to receive PLND. PLND was performed for 87.6% versus 38.3% of men undergoing ORP versus MIRP
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(P o.01). In addition, patients undergoing RALP had lower lymph node yields. Both associations were independent of tumor characteristics. Perhaps these observed differences depend more on the surgeon rather than the surgical approach. Menon et al,45 Ham et al,36 and Feicke et al46 reported their external iliac, internal iliac, and obturator lymph node dissection yields at the time of RALP. Mean node count ranged from 12–19. Mean positive node rates varied between 11%–24%. Compared to a limited template, an extended template was associated with an increased risk of complications. Chung et al evaluated extraperitoneal versus transperitoneal limited lymphadenectomy and found comparable lymph node yields for the two approaches.47 However, as expected, extraperitoneal lymph node dissection was associated with a slightly higher risk of postoperative lymphocele (6% v 4%). In a retrospective review of 1,047 men undergoing RP at our cancer center (626 RALP and 427 ORP), lymph node yields and lymph node involvement for each surgical approach were calculated. Mean lymph node yield for the RALP cohort (7.1; interquartile range, 4–10) was significantly higher than for the ORP cohort (6.0; range, 3–8) (P o.001). However, the percentage of patients with nodal involvement was equivalent between the two groups (1.1 v 2.3; P ¼ 0.167). Therefore, PLND at the time of RALP was deemed feasible and comparable to the standard open approach with equivalent lymph node yields and PLND-related complications.48 In a similar study by Cooperberg et al of 1,278 patients (716 ORP and 562 RALP), node counts were slightly greater in the ORP group.49 In conclusion, lymphadenectomy is feasible at the time of RALP and appears to be similar in terms of nodal counts. At the same time, data suggest it is not routinely performed during RALP when clinically indicated for intermediate- or high-risk disease. This warrants further attention in future studies.
Surgical Margin Status PSMs are an independent predictor of biochemical and local recurrence, as well as the need for secondary treatment following RP.50 However, the impact of PSMs on cancer-specific and overall survival remains controversial. Nevertheless, surgical margin status is commonly used as a surrogate endpoint for oncologic control after RP. To date, oncologic outcomes evaluable for comparative series have been primarily limited to PSM status. In 2007 Ficarra et al conducted an initial review of the early RALP literature.2 A total of 71 manuscripts were identified, including five nonrandomized studies comparing ORP with RALP and three studies
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comparing RALP with LRP. Notably, most of the studies were considered poor-quality case-control studies or case series and thus rated as level 4 evidence. Only a minority were comparative studies, considered level 3b evidence. Moreover, most studies failed to describe the method of evaluation of the prostatectomy specimen sampling. As a result, it is difficult to compare PSM rates between different series. Among the series evaluated in Ficarra’s review, the overall PSM rates varied widely between 2%–59%. However, the rates were highly dependent on the pathologic tumor stage. After stratifying by stage, the PSM rates were 4.7%–27% in pT2 cancers and 26%–67% in pT3 cancers. Over time, Ficarra et al observed that increasing surgeon experience and improvements in surgical techniques yielded progressive decline in the PSM rates.2 In fact, early series demonstrated that PSM rates approached those of contemporary ORP and LRP series. While Menon et al reported a PSM rate of 15% in the first 100 RALPs,51 this decreased to only 4% in the last 100 cases.52 Similar reduction in PSM rates can be seen in the community setting as well. Patel et al demonstrated a reduction in PSM from 13% in the initial 100 cases to 8% in the following 100 cases.12 Consistent with these findings, Ahlering and associates reported decreased PSMs in pT2 cases from 27% in the first 50 cases to 4.7% in the subsequent 90 cases.53 In addition to increasing experience, Ahlering et al employed modifications in the apical dissection, which may account for part of the improvements in their PSM rates. Given the lack of long-term follow-up, Ficarra et al in 2007 could not draw any definitive conclusions regarding oncologic outcomes after RALP.2 Beyond observing that PSM rates were similar for RALP, LRP, and ORP, other outcomes of interest such as biochemical recurrence and cancer-specific survival were only preliminary. Subsequently in 2009, Ficarra et al conducted another review of prostatectomy outcomes including oncologic endpoints, which were predominantly limited to PSM rates for MIRP.18 In a prospective, randomized single-surgeon study of 120 patients, Guazzoni et al in 2006 reported similar PSM rates for ORP and LRP (21.6% v 26%; P ¼ .28), even when stratifying by pathologic stage. Consistent with these findings, the majority of nonrandomized prospective studies comparing RRP and LRP reported similar results.18 Cumulative analysis of all comparative studies demonstrated overlapping PSM rates in ORP and LRP (RR, 1.08; 95% CI of RR, 0.97–1.19; P ¼ .17). Sensitivity analysis limited to only pT2 cancers confirmed no significant differences in PSM rates between ORP and LRP (RR, 1.02; 95% CI of RR, 0.83–1.26; P ¼ .85). Considering non-comparative studies evaluating surgical margin status, Ficarra et al
K.A. Healy and L.G. Gomella
in 2009 found PSM rates ranging from 11%–37% after ORP, from 11%–30% after LRP, and from 9.6%–26% after RALP. Among the studies included in Ficarra’s review in 2009, the largest prospective study found lower overall PSM rates in those patients treated by RALP than ORP.13 In this study of 200 patients undergoing RALP and 100 undergoing ORP, PSM was more frequent after ORP (23% v 9%; P o.05) and importantly pathological stages were comparable. Similar results favoring RALP were reported by Smith and colleagues in their retrospective study of 200 ORP patients versus 200 RALP patients with PSM rates of 35% versus 15%, respectively (P o.001).54 Among patients with pT2 prostate cancer, these differences remained statistically significant (ORP 24.1% v RALP 9.4%; P o.001). Cumulative analysis of comparative studies of overall PSM rates revealed a statistically significant advantage for RALP over ORP (RR, 1.58; 95% CI of RR, 1.29–1.94, P o.00001).18 Likewise, sensitivity analysis limited to prospective studies confirmed a significantly lower risk of PSM for RALP than ORP (RR, 1.90; 95% CI of RR, 1.24–2.89; P ¼ .003). Furthermore, on sensitivity analysis limited to pathologically localized cancers, the incidence of PSM remained significantly lower among RALP compared to ORP patients (RR, 2.23; 95% of CI RR, 1.36– 3.67; P ¼ .002). Lastly, Ficarra et al found no statistically significant difference in the PSM rate on cumulative analysis comparing LRP and RALP (RR, 0.97; 95% CI of RR, 0.65–1.46; P ¼ .9). Sensitivity analysis limited to pT2 cancers confirmed this PSM rate equivalence for these two minimally invasive approaches (RR, 0.74; 95% CI of RR, 0.42–1.33; P ¼ .31). Based on RALP series from 2008 and 2011, Novara et al found an overall mean PSM rate of 15% (range, 6.5%–32%).42 Importantly, however, Novara et al noted that many series failed to describe the pathologic protocol for sampling the RALP specimens, which affects the PSM rate. As expected, the PSM rates are highly stage-dependent. After stratifying by pathologic tumor stage, the mean PSM rate was 9% (4%–23%) in pT2, 37% (29%–50%) in pT3, and 50% (40%–75%) in pT4 disease. Considering the location of the PSM, the most common site was the prostatic apex in 5% (1%–7%), postero-laterally in 2.6% (2%– 21%), and anteriorly in 0.6% (1%–2%). Multifocal PSMs were present in 2.2% (2%–9%) of RALP cases. Based on comparative studies evaluating ORP and RALP, cumulative analysis demonstrated only nonstatistically significant differences in overall PSM rates (21% v 20%; OR, 1.21; P ¼ .19). Among pT2 cancers, PSM rates were also similar following ORP and RALP (12% v 11%; OR, 1.25; P ¼ .31). Comparing LRP and RALP, overall PSM rates (18% v 18%; OR, 1.12; P ¼ .47) as well as PSM rates in pT2 cancers
Retropubic, laparoscopic, or robotic radical prostatectomy?
(11% v 12%; OR, 0.99; P ¼ .97) were equivalent. Taken together, Novara et al found that no surgical approach demonstrated superiority from a PSM standpoint. Rather, tumor characteristics such as PSA, pathologic stage, Gleason score, and prostate volume appear to be the most relevant predictors of PSM. Importantly, this most recent cumulative analysis in 201242 by Novara’s group failed to reconfirm the advantages of RALP in terms of PSM rates that were previously reported in their 2009 analysis.18 The incidences of PSMs found reported in Novara and colleagues’ analysis are consistent with those of a recent large multicenter collaboration by Patel et al, which included 8,418 patients who underwent RALP from seven institutions.55 The overall PSM rate was 15.7% (1,272 of 8,095 patients). Based on pathological stage, the PSM rates for pT2 and pT3 disease were 9.45% and 37.2%, respectively. Multivariate analysis showed that pathological stage (pT2 v pT3 OR ¼ 4.588; P o.001) and preoperative PSA (r4 v 410 ng/mL; OR, 2.918; P o.001) were the most important predictors of PSMs after RALP. Again, predictors of PSM rates in RALP series are congruent with the prior ORP literature. Several studies have assessed the impact of different modifications in RALP technique on PSM rates. Basically, technical details in every step of the procedure have been evaluated, such as trans- versus extra-peritoneal, bladder neck preservation, and extra- versus inter-fascial neurovascular bundle (NVB) dissection. In particular, three studies examined the effect of different techniques for control of the dorsal venous complex (DVC) on PSMs. Compared to DVC incision following ligation, Guru and colleagues found that incision without ligation was associated with significant decreased risk of apical PSMS (2% v 8%; P ¼ .02).56 Conversely, Lei et al failed to demonstrate any statistically significant difference between athermal division and selective suturing of the DVC versus nonselective suture ligation and athermal division in terms of overall PSMs (12% v 12%; P ¼ 1) or apical PSMs (1% v 3%; P ¼ 0.361).57 However, athermal division and selective suturing was associated with significantly higher early urinary continence. Lastly, Wu et al compared staple v suture ligation of the DVC during RALP and found that staple ligation was associated with lower overall PSMs (6% v 18%; P ¼ .02) as well as apical PSMs (2% v 13%; P ¼ .005).58 Recently Tewari et al employed propensity adjustment in their systematic review and meta-analysis and reported overall PSM rates of 24.2% ORP, 20.4% LRP, and 16.2% RALP.39 For pT2 cancers, PSM rates were 16.6% ORP, 13.0% LRP, and 10.7% RALP. After propensity-score matching, RALP was significantly better than LRP for both overall and pT2 PSM rates (overall PSM P ¼ .002; pT2 PSM P ¼.01). On the
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other hand, ORP and RALP were found to be equivalent for both comparisons.
Biochemical Recurrence Considering BCR in RALP series from 2008 to 2011,42 two studies reported outcomes with at least 5-year follow-up data.59,60 Menon et al in 2010 evaluated BCR after RALP in 1,384 patients treated at the Vattikuti Urology Institute with a median follow-up of 60.2 months.59 Using a PSA cutoff Z.2 ng/mL, the reported BCR-free survival rates were 90.6%, 86.6%, and 81.0% at 3, 5, and 7 years, respectively. Median time to BCR was 20.4 months. On multivariate analysis, the strongest predictors of BCR were pathologic Gleason grade 8–10 (HR, 5.37; 95% CI, 2.99–9.65; P o.0001) and pathologic stage T3b/4 (HR, 2.71; 95% CI, 1.67–4.40; P o.0001). In a smaller series of 184 patients with Z5 year followup, Suardi et al in 2012 reported similar BCR outcomes again defining BCR as PSA Z0.2 ng/mL.60 Median follow-up was 67.5 months. The 3-, 5-, and 7-year BCR-free survival rates were 94%, 86%, and 81%, respectively, and the mean time to BCR was 83.8 months. Multivariate analysis demonstrated that the presence of seminal vesicle invasion (HR, 5.14; P ¼ .004) and Gleason sum 8–10 (HR, 3.04; P ¼ .04) were independent predictors of BCR. Based on these studies, RALP appears to confer effective 5-year biochemical control for the treatment of organconfined prostate cancer. Among comparative studies of ORP, LRP, and RALP, Novara et al reported no significant differences in BCR-free survival estimates between ORP and RALP (HR, 0.9; 95% CI, 0.7–1.2, P ¼ .526) or between LRP and RALP (HR, 0.5; 95% CI, 0.2–1.3; P ¼ .141).42 Regardless of the surgical approach, BCR rates were found to be equivalent. Data are limited on the need for adjuvant therapy following RALP either based on BCR or PSM. Among RALP series published between 2008 and 2011,42 the reported use of adjuvant therapies varied widely between 0.5%–23%, (mean, 4%). Therefore, comparative analysis on surgical approaches is not yet feasible.
CONCLUSIONS ORP and RALP remain as acceptable treatments for localized prostate cancer. Although RALP has proven itself as an acceptable alternative to ORP with reasonable risk of complications, it has not been shown to be convincingly superior to ORP. Compared with ORP and LRP, RALP was consistently associated with less blood loss and lower transfusion rates with higher costs. In addition to surgical approach, patient factors and surgeon experience
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likely impact perioperative outcomes but can be hard to capture in these comparative analyses. Commentaries often cite that surgical experience may be more critical than the use of one technique over the other.61 Considerable disparities in measurement and reporting practices of perioperative outcomes continue to make direct comparisons difficult. Future prospective studies of RP perioperative outcomes should aim to use rigorous methodology and established criteria for standardized reporting.
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13.
14.
15.
16.
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