Urology Clinical Evidence
Significant Publications
Below are links to abstracts of featured publications supporting the clinical effectiveness of da Vinci® Urologic Surgery.
- Trinh QD, Sammon J, Sun M, Ravi P, Ghani KR, Bianchi M, Jeong W, Shariat SF, Hansen J, Schmitges J, Jeldres C, Rogers CG, Peabody JO, Montorsi F, Menon M, Karakiewicz PI. Perioperative outcomes of robot-assisted radical prostatectomy compared with open radical prostatectomy: results from the nationwide inpatient sample.Eur Urol. 2012 Apr;61(4):679-85. Epub 2011 Dec 22.
Full text article.
Abstract
BACKGROUND: Prior to the introduction and dissemination of robot-assisted radical prostatectomy (RARP), population-based studies comparing open radical prostatectomy (ORP) and minimally invasive radical prostatectomy (MIRP) found no clinically significant difference in perioperative complication rates.
OBJECTIVE: Assess the rate of RARP utilization and reexamine the difference in perioperative complication rates between RARP and ORP in light of RARP's supplanting laparoscopic radical prostatectomy (LRP) as the most common MIRP technique.
DESIGN, SETTING, AND PARTICIPANTS: As of October 2008, a robot-assisted modifier was introduced to denote robot-assisted procedures. Relying on the Nationwide Inpatient Sample between October 2008 and December 2009, patients treated with radical prostatectomy (RP) were identified. The robot-assisted modifier (17.4x) was used to identify RARP (n=11 889). Patients with the minimally invasive modifier code (54.21) without the robot-assisted modifier were classified as having undergone LRP and were removed from further analyses. The remainder were classified as ORP patients (n=7389).
INTERVENTION: All patients underwent RARP or ORP.
MEASUREMENTS: We compared the rates of blood transfusions, intraoperative and postoperative complications, prolonged length of stay (pLOS), and in-hospital mortality. Multivariable logistic regression analyses of propensity score-matched populations, fitted with general estimation equations for clustering among hospitals, further adjusted for confounding factors.
RESULTS AND LIMITATIONS: Of 19 462 RPs, 61.1% were RARPs, 38.0% were ORPs, and 0.9% were LRPs. In multivariable analyses of propensity score-matched populations, patients undergoing RARP were less likely to receive a blood transfusion (odds ratio [OR]: 0.34; 95% confidence interval [CI], 0.28-0.40), 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), and to experience a pLOS (OR: 0.28; 95% CI, 0.26-0.30). Limitations of this study include lack of adjustment for tumor characteristics, surgeon volume, learning curve effect, and longitudinal follow-up.
CONCLUSIONS: RARP has supplanted ORP as the most common surgical approach for RP. Moreover, we demonstrate superior adjusted perioperative outcomes after RARP in virtually all examined outcomes.
- Kowalczyk KJ, Levy JM, Caplan CF, Lipsitz SR, Yu HY, Gu X, Hu JC. Temporal national trends of minimally invasive and retropubic radical prostatectomy outcomes from 2003 to 2007: results from the 100% Medicare sample. Eur Urol. 2012 Apr;61(4):803-9. doi: 10.1016/j.eururo.2011.12.020. Epub 2011 Dec 21.
Full text article.
Abstract
BACKGROUND: Although the use of minimally invasive radical prostatectomy (MIRP) has increased, there are few comprehensive population-based studies assessing temporal trends and outcomes relative to retropubic radical prostatectomy (RRP).
OBJECTIVE: Assess temporal trends in the utilization and outcomes of MIRP and RRP among US Medicare beneficiaries from 2003 to 2007.
DESIGN, SETTING, AND PARTICIPANTS: A population-based retrospective study of 19 594 MIRP and 58 638 RRP procedures was performed from 2003 to 2007 from the 100% Medicare sample, composed of almost all US men ≥ 65 yr of age.
INTERVENTION: MIRP and RRP.
MEASUREMENTS: We measured 30-d outcomes (cardiac, respiratory, vascular, genitourinary, miscellaneous medical, miscellaneous surgical, wound complications, blood transfusions, and death), cystography utilization within 6 wk of surgery, and late complications (anastomotic stricture, ureteral complications, rectourethral fistulae, lymphocele, and corrective incontinence surgery).
RESULTS AND LIMITATIONS: From 2003 to 2007, MIRP increased from 4.9% to 44.5% of radical prostatectomies while RRP decreased from 89.4% to 52.9%. MIRP versus RRP subjects were younger (p<0.001) and had fewer comorbidities (p<0.001). Decreased MIRP genitourinary complications (6.2-4.1%; p = 0.002), miscellaneous surgical complications (4.7-3.7%; p=0.030), transfusions (3.5-2.2%; p=0.005), and postoperative cystography utilization (40.3-34.1%; p<0.001) were observed over time. Conversely, overall RRP perioperative complications increased (27.4-32.0%; p<0.001), including an increase in perioperative mortality (0.5-0.8%, p=0.009). Late RRP complications increased, with the exception of fewer anastomotic strictures (10.2-8.8%; p=0.002). In adjusted analyses, RRP versus MIRP was associated with increased 30-d mortality (odds ratio [OR]: 2.67; 95% confidence interval [CI], 1.55-4.59; p<0.001) and more perioperative (OR: 1.60; 95% CI, 1.45-1.76; p<0.001) and late complications (OR: 2.52; 95% CI, 2.20-2.89; p<0.001). Limitations include the inability to distinguish MIRP with versus without robotic assistance and also the lack of pathologic information.
CONCLUSIONS: From 2003 to 2007, there were fewer MIRP transfusions, genitourinary complications, and miscellaneous surgical complications, whereas most RRP perioperative and late complications increased. RRP versus MIRP was associated with more postoperative mortality and complications.
- Tewari A, Sooriakumaran P, Bloch DA, Seshadri-Kreaden U, Hebert AE, Wiklund P. Positive Surgical Margin and Perioperative Complication Rates of Primary Surgical Treatments for Prostate Cancer: A Systematic Review and Meta-Analysis Comparing Retropubic, Laparoscopic, and Robotic Prostatectomy. Eur Urol. 2012 Feb 24. [Epub ahead of print].
Full text article.
Abstract
CONTEXT: Radical prostatectomy (RP) approaches have rarely been compared adequately with regard to margin and perioperative complication rates.
OBJECTIVE: Review the literature from 2002 to 2010 and compare margin and perioperative complication rates for open retropubic RP (ORP), laparoscopic RP (LRP), and robot-assisted LRP (RALP).
EVIDENCE ACQUISITION: Summary data were abstracted from 400 original research articles representing 167,184 ORP, 57,303 LRP, and 62,389 RALP patients (total: 286,876). Articles were found through PubMed and Scopus searches and met a priori inclusion criteria (eg, surgery after 1990, reporting margin rates and/or perioperative complications, study size>25 cases). The primary outcomes were positive surgical margin (PSM) rates, as well as total intra- and perioperative complication rates. Secondary outcomes included blood loss, transfusions, conversions, length of hospital stay, and rates for specific individual complications. Weighted averages were compared for each outcome using propensity adjustment.
EVIDENCE SYNTHESIS: After propensity adjustment, the LRP group had higher positive surgical margin rates than the RALP group but similar rates to the ORP group. LRP and RALP showed significantly lower blood loss and transfusions, and a shorter length of hospital stay than the ORP group. Total perioperative complication rates were higher for ORP and LRP than for RALP. Total intraoperative complication rates were low for all modalities but lowest for RALP. Rates for readmission, reoperation, nerve, ureteral, and rectal injury, deep vein thrombosis, pneumonia, hematoma, lymphocele, anastomotic leak, fistula, and wound infection showed significant differences between groups, generally favoring RALP. The lack of randomized controlled trials, use of margin status as an indicator of oncologic control, and inability to perform cost comparisons are limitations of this study.
CONCLUSIONS: This meta-analysis demonstrates that RALP is at least equivalent to ORP or LRP in terms of margin rates and suggests that RALP provides certain advantages, especially regarding decreased adverse events.
- Rocco B, Matei DV, Melegari S, Ospina JC, Mazzoleni F, Errico G, Mastropasqua M, Santoro L, Detti S, de Cobelli O. Robotic vs open prostatectomy in a laparoscopically naive centre: a matched-pair analysis. BJU Int. 2009 Oct;104(7):991-5. Epub 2009 May 5. View abstract. Full text article.
Abstract
OBJECTIVE: To compare the early oncological, perioperative and functional outcomes of robotic-assisted radical prostatectomy (RARP) vs open retropubic RP (RRP) in a laparoscopically naive centre, as robotic assistance aids the laparoscopically naive surgeon in minimally invasive prostate surgery, by offering magnification and superior dexterity.
PATIENTS AND METHODS: From 1 November 2006 to 31 December 2007, 120 patients had RARP; this group was followed prospectively and evaluated for early oncological, perioperative and functional outcomes (measured at 3, 6 and 12 months after surgery), and compared to a historical control group of consecutive patients who had RRP from 20 May 2004 to 28 February 2007. All patients were operated by the same laparoscopically naive surgeons. The comparison was by matched-pair analysis.
RESULTS: The baseline characteristics of the two groups were equivalent, although there was a higher percentage of patients with pT3/pT4 disease in the RRP group. As a proxy for oncological outcome, positive surgical margins were equivalent in the two groups (22% RARP vs 25% RRP, P = 0.77). The overall mean (range) surgical duration was significantly longer in RARP group, at 215 (165-450) min vs 160 (90-240) min in the RRP group (P < 0.001). However, RARP had a statistically significant advantage over RRP for estimated blood loss, of 200 vs 800 mL (P < 0.001), duration of catheterization (6 vs 7 days P < 0.001) and length of stay (3 vs 6 days, P < 0.001) The 3, 6 and 12-month continence rates were 70%, 93% and 97% vs 63%, 83% and 88% after RARP and RRP, respectively (P = 0.15, 0.011 and 0.014). The 3, 6 and 12 month overall potency recovery rate was 31%, 43% and 61% vs 18%, 31% and 41%, after RARP and RRP, respectively (P = 0.006, 0.045 and 0.003).
CONCLUSION: Our initial experience showed the feasibility of RARP in a laparoscopically naive centre. RRP seems to be a faster procedure, whereas RARP provided better results in terms of estimated blood loss, hospitalization and functional results. The early oncological outcome seemed to be equivalent in the two groups.
- Cooperberg MR, Vickers AJ, Broering JM, Carroll PR. [For the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) Investigators.] Comparative risk-adjusted mortality outcomes after primary surgery, radiotherapy, or androgen-deprivation therapy for localized prostate cancer. Cancer. 2010 Nov 15;116(22):5226-34. doi: 10.1002/cncr.25456.
View abstract. Full text article.
Abstract
BACKGROUND: Because no adequate randomized trials have compared active treatment modalities for localized prostate cancer, the authors analyzed risk-adjusted, cancer-specific mortality outcomes among men who underwent radical prostatectomy, men who received external-beam radiation therapy, and men who received primary androgen-deprivation therapy.
METHODS: The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry comprises men from 40 urologic practice sites who are followed prospectively under uniform protocols, regardless of treatment. In the current study, 7538 men with localized disease were analyzed. Prostate cancer risk was assessed using the Kattan preoperative nomogram and the Cancer of the Prostate Risk Assessment (CAPRA) score, both well validated instruments that are calculated from clinical data at the time of diagnosis. A parametric survival model was constructed to compare outcomes across treatments adjusting for risk and age.
RESULTS: In total, 266 men died of prostate cancer during follow-up. Adjusting for age and risk, the hazard ratio for cancer-specific mortality relative to prostatectomy was 2.21 (95% confidence interval [CI], 1.50-3.24) for radiation therapy and 3.22 (95% CI, 2.16-4.81) for androgen deprivation. Absolute differences between prostatectomy and radiation therapy were small for men at low risk but increased substantially for men at intermediate and high risk. These results were robust to a variety of different analytic techniques, including competing risks regression analysis, adjustment by CAPRA score rather than Kattan score, and examination of overall survival as the endpoint.
CONCLUSIONS: Prostatectomy for localized prostate cancer was associated with a significant and substantial reduction in mortality relative to radiation therapy and androgen-deprivation monotherapy. Although this was not a randomized study, given the multiple adjustments and sensitivity analyses, it is unlikely that unmeasured confounding would account for the large observed differences in survival.
- Benway BM, Bhayani SB, Rogers CG, Dulabon LM, Patel MN, Lipkin M, Wang AJ, Stifelman MD. Robot assisted partial nephrectomy versus laparoscopic partial nephrectomy for renal tumors: a multi-institutional analysis of perioperative outcomes. J Urol. 2009 Sep;182(3):866-72. Epub 2009 Jul 17
View abstract. Full text article.
Abstract
PURPOSE: Robot assisted partial nephrectomy is rapidly emerging as an alternative to laparoscopic partial nephrectomy for the treatment of renal malignancy. We present the largest multi-institution comparison of the 2 approaches to date, describing outcomes from 3 experienced minimally invasive surgeons.
MATERIALS AND METHODS: We performed a retrospective chart review, evaluating 118 consecutive laparoscopic partial nephrectomies and 129 consecutive robot assisted partial nephrectomies performed between 2004 and 2008 by 3 experienced minimally invasive surgeons at 3 academic centers. Perioperative data were recorded along with clinical and pathological outcomes.
RESULTS: The robot assisted and laparoscopic partial nephrectomy groups were equivalent in terms of age, gender, body mass index, American Society of Anesthesiologists classification (2.3 vs 2.4) and radiographic tumor size (2.9 vs 2.6 cm), respectively. Comparison of operative data revealed no significant differences in terms of overall operative time (189 vs 174 minutes), collecting system entry (47% vs 54%), pathological tumor size (2.8 vs 2.5 cm) and positive margin rate (3.9% vs 1%) for robot assisted and laparoscopic partial nephrectomy, respectively. Intraoperative blood loss was less for robot assisted vs laparoscopic partial nephrectomy (155 vs 196 ml, p = 0.03) as was length of hospital stay (2.4 vs 2.7 days, p <0.0001). Warm ischemia times were significantly shorter in the robot assisted partial nephrectomy series (19.7 vs 28.4 minutes, p <0.0001). Subset analysis based on complexity revealed that tumor complexity had no effect on operative time or estimated blood loss for robot assisted partial nephrectomy, although complexity did affect these factors for laparoscopic partial nephrectomy. In addition, for simple and complex tumors robot assisted partial nephrectomy provided significantly shorter warm ischemic time than laparoscopic partial nephrectomy (15.3 vs 25.2 minutes for simple, p <0.0001; 25.9 vs 36.7 minutes for complex, p = 0.0002). There were no intraoperative complications during robot assisted partial nephrectomy vs 1 complication during laparoscopic partial nephrectomy. Postoperative complication rates were similar for robot assisted and laparoscopic partial nephrectomy (8.6% vs 10.2%).
CONCLUSIONS: Robot assisted partial nephrectomy is a safe and viable alternative to laparoscopic partial nephrectomy, providing equivalent early oncological outcomes and comparable morbidity to a traditional laparoscopic approach. Moreover robot assisted partial nephrectomy appears to offer the advantages of decreased hospital stay as well as significantly less intraoperative blood loss and shorter warm ischemia time, the latter of which may help to provide maximal preservation of renal reserve. In addition, operative parameters for robot assisted partial nephrectomy appear to be less affected by tumor complexity compared to laparoscopic partial nephrectomy. Interestingly while the advantages of robotic surgery have historically been believed to aid laparoscopic naïve surgeons, these data indicate that robot assisted partial nephrectomy may also benefit experienced laparoscopic surgeons.
- Khalifeh A, Autorino R, Hillyer SP, Laydner H, Eyraud R, Panumatrassamee K, Long JA, Kaouk JH. Comparative Outcomes and Assessment of Trifecta in 500 Robotic and Laparoscopic Partial Nephrectomies: A Single Surgeon Experience. J Urol. 2012 Oct 16. pii: S0022-5347(12)05220-2. doi: 10.1016/j.juro.2012.10.021. [Epub ahead of print]
View abstract. Full text article.
Abstract
PURPOSE: We report a comparative analysis of a large series of laparoscopic and robotic partial nephrectomies performed by a high volume single surgeon at a tertiary care institution.
MATERIALS AND METHODS: We retrospectively reviewed the medical charts of 500 patients treated with minimally invasive partial nephrectomy by a single surgeon between March 2002 and February 2012. Demographic and perioperative data were collected and statistically analyzed. R.E.N.A.L. (radius, exophytic/endophytic properties, nearness of tumor to the collecting system or sinus in mm, anterior/posterior and location relative to polar lines) nephrometry score was used to score tumors. Those scored as moderate and high complexity were designated as complex. Trifecta was defined as a combination of warm ischemia time less than 25 minutes, negative surgical margins and no perioperative complications.
RESULTS: Two groups were identified, including 261 patients with robotic and 231 with laparoscopic partial nephrectomy. Demographics were similar in the groups. The robotic group was significantly more morbid (Charlson comorbidity index 3.75 vs 1.26), included more complex tumors (R.E.N.A.L. score 5.98 vs 7.2), and had lower operative (169.9 vs 191.7 minutes) and warm ischemia (17.9 vs 25.2 minutes) time, intraoperative (2.6% vs 5.6%, each p <0.001) and postoperative (24.53% vs 32.03%, p = 0.004) complications, and positive margin rate (2.9% vs 5.6%, p <0.001). Thus, a higher overall trifecta rate was observed for robotic partial nephrectomy (58.7% vs 31.6%, p <0.001). The laparoscopic group had longer followup (3.43 vs 1.51 years, p <0.001) and no significant difference in postoperative changes in renal function. Main study limitations were the retrospective nature, arbitrary definition of trifecta and shorter followup in the RPN group.
CONCLUSIONS: Our large comparative analysis shows that robotic partial nephrectomy offers a wider range of indications, better operative outcomes and lower perioperative morbidity than laparoscopic partial nephrectomy. Overall, the quest for trifecta seems to be better accomplished by robotic partial nephrectomy, which is likely to become the new standard for minimally invasive partial nephrectomy.
- Ng CK, Kauffman EC, Lee MM, Otto BJ, Portnoff A, Ehrlich JR, Schwartz MJ, Wang GJ, Scherr DS. A comparison of postoperative complications in open versus robotic cystectomy. Eur Urol. 2010 Feb;57(2):274-81. Epub 2009 Jun 10
View abstract. Full text article.
Abstract
BACKGROUND: Robotic cystectomy is an emerging alternative for treatment of invasive bladder cancer (BCa). However, reduction in postoperative morbidity relative to the open approach has not been demonstrated.
OBJECTIVE: To compare complication rates in patients undergoing robotic versus open radical cystectomy (RC).
DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study of 187 consecutive patients undergoing RC at our institution-104 open RC, 83 robotic RC.
INTERVENTION: Open or robotic RC with urinary diversion.
MEASUREMENTS: Demographic, perioperative, and complication data were recorded prospectively. Thirty-day and 90-d complication rates were assessed using the modified Clavien complication scale. Data were evaluated using chi(2) and multivariate logistic regression analyses.
RESULTS AND LIMITATIONS: At 30 d, the open group demonstrated a higher overall complication rate (59% vs 41%; p=0.04) as well as more major complications (30% vs 10%; p=0.007). At 90 d, the overall complication rate was greater in the open group, but this was not statistically significant (62% vs 48%; p=0.07). However, there was a significantly higher major complication rate in the open cohort (31% vs 17%; p=0.03). When subjected to logistic regression analysis, robotic cystectomy was an independent predictor of fewer overall and major complications at 30 and 90 d. High American Society of Anesthesiologists (ASA) score (3-4) and longer surgical time were independent predictors of major complications. Though this is one of the largest published RC series, the sample size is relatively small. Moreover, despite the two patient cohorts being similarly matched, the study was not performed in a randomized fashion.
CONCLUSIONS: Patients undergoing robotic cystectomy experienced fewer postoperative complications than those undergoing open cystectomy. Robotic cystectomy is an independent predictor of fewer overall and major complications. Until long-term oncologic results are available, robotic cystectomy should still be considered investigational.
Number of Publications, by Level of Evidence
The table below summarizes the clinical publications relating to da Vinci Urologic Surgery that meet the higher level of evidence standard of level 1, 2a or 2b, as defined by guidelines from the Department of Public Health Services, King's College, London.
| LEVEL | DESCRIPTION |
New in February | Total |
| Level 1 | Randomized control trial |
0 |
10 |
| Level 2a | Non-randomized prospective study including a comparison cohort |
1 |
59 |
| Level 2b | Non-randomized retrospective study including a comparison cohort |
10 |
359 |
| Lower level publications: |
| Level 3 | Single cohort (non-comparison) studies |
16 |
2271 |
| Level 4 | Case studies |
14 |
| Level 5 | Opinion publications |
12 |
| TOTAL | |
53 |
2722 |
Clinical Research for da Vinci Surgeons & Personnel
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While clinical studies support the effectiveness of the da Vinci Surgical System when used in minimally invasive surgery, individual results may vary. There are no guarantees of outcome. All surgeries involve the risk of major complications. Before you decide on surgery, discuss treatment options with your doctor. Understanding the risks of each treatment can help you make the best decision for your individual situation. Surgery with the da Vinci Surgical System may not be appropriate for every individual; it may not be applicable to your condition. Always ask your doctor about all treatment options, as well as their risks and benefits. Only your doctor can determine whether da Vinci Surgery is appropriate for your situation. The clinical information and opinions, including any inaccuracies expressed in this material by patients or doctor about da Vinci Surgery are not necessarily those of Intuitive Surgical, Inc. and should not be considered as substitute for medical advice provided by your doctor. All persons depicted are models unless otherwise noted. © 2012 Intuitive Surgical. All rights reserved. Intuitive, Intuitive Surgical, da Vinci, da Vinci S, da Vinci Si, Single-Site, InSite, TilePro and EndoWrist are trademarks or registered trademarks of Intuitive Surgical. All other product names are trademarks or registered trademarks of their respective holders.