Urology Clinical Evidence
Featured Publications
Below are links to featured publications that support the clinical effectiveness of da Vinci® Urologic Surgery.
- 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 Aug 5. View abstract.
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.
- Ficarra V, Novara G, Fracalanza S, D'Elia C, Secco S, Iafrate M, Cavalleri S, Artibani W. A prospective, non-randomized trial comparing robot-assisted laparoscopic and retropubic radical prostatectomy in one European institution. BJU Int. 2009 Aug;104(4):534-9. Epub 2009 Mar 5. View abstract.
Abstract
OBJECTIVE: To compare the functional results of two contemporary series of patients with clinically localized prostate cancer treated by robot-assisted laparoscopic prostatectomy (RALP) or retropubic radical prostatectomy (RRP).
PATIENTS AND METHODS: This was a non-randomized prospective comparative study of all patients undergoing RALP or RRP for clinically localized prostate cancer at our institution from February 2006 to April 2007.
RESULTS: We enrolled 105 patients in the RRP and 103 in the RALP group; the two groups were comparable for all clinical and pathological variables, except median age. For RRP and RALP the respective median operative duration was 135 and 185 min (P < 0.001), the intraoperative blood loss 500 and 300 mL (P < 0.001) and postoperative transfusion rates 14% and 1.9% (P < 0.01). There were complications in 9.7% and 10.4% of the patients (P = 0.854) after RRP and RALP, respectively; the positive surgical margin rates in pT2 cancers were 12.2% and 11.7% (P = 0.70). For urinary continence, 41% of patients having RRP and 68.9% of those having RALP were continent at catheter removal (P < 0.001). The 12-month continence rates were 88% after RRP and 97% after RALP (P = 0.01), with the mean time to continence being 75 and 25 days (P < 0.001), respectively. At the 12-month follow-up, 20 of 41 patients having bilateral nerve-sparing RRP (49%) and 52 of 64 having bilateral nerve-sparing RALP (81%) (P < 0.001) had recovery of erectile function.
CONCLUSIONS: RALP offers better results than RRP in terms of urinary continence and erectile function recovery, with similar positive surgical margin rates.
- Coelho RF, Rocco B, Patel MB, Orvieto MA, Chauhan S, Ficarra V, Melegari S, Palmer KJ, Patel VR. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a critical review of outcomes reported by high-volume centers. J Endourol. 2010 Dec;24(12):2003-15. Epub 2010 Oct 13. View abstract.
Abstract
PURPOSE: To critically review perioperative outcomes, positive surgical margin (PSM) rates, and functional outcomes of several large series of retropubic radical prostatectomy (RRP), laparoscopic RP (LRP), and robot-assisted radical prostatectomy (RARP) currently available in the literature.
METHODS: A Medline database search was performed from November 1994 to May 2009, using medical subject heading search terms "prostatectomy" and "Outcome Assessment (Health Care)" and text words "retropubic," "robotic," and "laparoscopic." Only studies with a sample size of 250 or more patients were considered. Weighted means were calculated for all outcomes using the number of patients included in each study as the weighing factor.
RESULTS: We identified 30 articles for RRP, 14 for LRP, and 14 for RARP. The mean intraoperative and postoperative RRP transfusion rates for RRP, LRP, and RARP were 20.1%, 3.5%, and 1.4%, respectively. The weighted mean postoperative complication rates for RRP, LRP, and RARP were 10.3% (4.8% to 26.9%), 10.98% (8.9 to 27.7%), and 10.3% (4.3% to 15.7%), respectively. RARP revealed a mean overall PSM rate of 13.6%, whereas LRP and RRP yielded a PSM of 21.3% and 24%, respectively. The weighted mean continence rates at 12 month follow-up for RRP, LRP, and RARP were 79%, 84.8%, and 92%, respectively. The weighted mean potency rates for patients who underwent unilateral or bilateral nerve sparing, at 12 month follow-up, were 43.1% and 60.6% for RRP, 31.1% and 54% for LRP, and 59.9% and 93.5% for RARP.
CONCLUSIONS: RRP, LRP, and RARP performed in high-volume centers are safe options for treatment of patients with localized prostate cancer, presenting similar overall complication rates. LRP and RARP, however, are associated with decreased operative blood loss and decreased risk of transfusion when compared with RRP. Our analysis including high-volume centers also showed lower weighted mean PSM rates and higher continence and potency rates after RARP compared with RRP and LRP. However, the lack of randomized trials precludes definitive conclusions.
- 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.
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.
- Nix J, Smith A, Kurpad R, Nielsen ME, Wallen EM, Pruthi RS. Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: perioperative and pathologic results. Eur Urol. 2010 Feb;57(2):196-201. Epub 2009 Oct 20.
View abstract.
Abstract
BACKGROUND: In recent years, surgeons have begun to report case series of minimally invasive approaches to radical cystectomy, including robotic-assisted techniques demonstrating the surgical feasibility of this procedure with the potential of lower blood loss and more rapid return of bowel function and hospital discharge. Despite these experiences and observations, at this point high levels of clinical evidence with regard to the benefits of robotic cystectomy are absent, and the current experiences represent case series with limited comparisons to historical controls at best.
OBJECTIVE: We report our results on a prospective randomized trial of open versus robotic-assisted laparoscopic radical cystectomy with regard to perioperative outcomes, complications, and short-term narcotic usage.
RESULTS: A prospective randomized single-center noninferiority study comparing open versus robotic approaches to cystectomy in patients who are candidates for radical cystectomy for urothelial carcinoma of the bladder. Of the 41 patients who underwent surgery, 21 were randomized to the robotic approach and 20 to the open technique.
DESIGN, SETTING, AND PARTICIPANTS: 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.
INTERVENTION: Radical cystectomy, bilateral pelvic lymphadenectomy, and urinary diversion by either an open approach or by a robotic-assisted laparoscopic technique.
MEASUREMENTS: The primary end point was lymph node (LN) yield with a noninferiority margin of four LNs. Secondary end points included demographic characteristics, perioperative outcomes, pathologic results, and short-term narcotic use.
RESULTS AND LIMITATIONS: On univariate analysis, no significant differences were found between the two groups with regard to age, sex, body mass index, American Society of Anesthesiologists classification, anticoagulation regimen of aspirin, clinical stage, or diversion type. Significant differences were noted in operating room time, estimated blood loss, time to flatus, time to bowel movement, and use of inpatient morphine sulfate equivalents. There was no significant difference in regard to overall complication rate or hospital stay. On surgical pathology, in the robotic group 14 patients had pT2 disease or higher; 3 patients had pT3/T4 disease; and 4 patients had node-positive disease. In the open group, eight patients had pT2 disease or higher; five patients had pT3/T4 disease; and seven patients had node-positive disease. The mean number of LNs removed was 19 in the robotic group versus 18 in the open group. Potential study limitations include the limited clinical and oncologic follow-up and the relatively small and single-institution nature of the study.
CONCLUSIONS: We present the results of a prospective randomized controlled noninferiority study with a primary end point of LN yield, demonstrating the robotic approach to be noninferior to the open approach. The robotic approach also compares favorably with the open approach in several perioperative parameters. Copyright 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Number of “Level of Evidence” Publications
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 April | Total |
| Level 1 | Randomized control trial |
0 |
7 |
| Level 2a | Non-randomized prospective study including a comparison cohort |
2 |
41 |
| Level 2b | Non-randomized retrospective study including a comparison cohort |
16 |
250 |
| Lower level publications: |
| Level 3 | Single cohort (non-comparison) studies |
19 |
1876 |
| Level 4 | Case studies |
10 |
| Level 5 | Opinion publications |
21 |
| TOTAL | |
69 |
2197 |
Clinical Research for da Vinci® Practitioners
Clinical practitioners of da Vinci Surgery can perform detailed research from the world's largest collection of robotically-assisted surgery abstracts on the da Vinci Surgery Online Community: www.daVinciSurgeryCommunity.com.
This site is open to da Vinci practitioners and personnel only and requires free sign up. Access to the Clinical Research section of the site requires validation, which can take 1-2 business days.
Sign up now to access the da Vinci Surgery database.
To determine whether the FDA has cleared da Vinci Surgical System for use in a specific procedure, please refer to the Regulatory Clearance page.
PN 8756434 Rev A 12/11