Urology Clinical Evidence
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.
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.
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.
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.
- 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.
- 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.
- 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.
- 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.
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|
Clinical Research for da Vinci Surgeons & Personnel
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Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following: injury to tissues/organs, bleeding, infection and internal scarring that can cause long-lasting dysfunction/pain. Risks of surgery also include the potential for equipment failure and/or human error. Individual surgical results may vary.
Risks specific to minimally invasive surgery, including da Vinci Surgery, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; temporary pain/discomfort from the use of air or gas in the procedure; a longer operation and time under anesthesia and conversion to another surgical technique. If your doctor needs to convert the surgery to another surgical technique, this could result in a longer operative time, additional time under anesthesia, additional or larger incisions and/or increased complications.
Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci® Surgery. Patients should talk to their doctor to decide if da Vinci Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. For Important Safety Information, including surgical risks, indications, and considerations and contraindications for use, please also refer to www.davincisurgery.com/safety and www.intuitivesurgical.com/safety. Unless otherwise noted, all people depicted are models.
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