Clinical Evidence - Urology

Urology - Clinical Evidence

Publications referenced on this page were conducted on the da Vinci^® Si, da Vinci^® S, and da Vinci^® Standard systems. No publications are currently available for the da Vinci^® Xi system.

Featured Publications

Below are links to featured publications that support the clinical effectiveness of da Vinci^® Urologic Surgery.

Prostate (7)

2013 Davis J, Kreaden U, Gabbert J and Thomas R "Learning Curve Assessment of Robot-Assisted Radical Prostatectomy Compared to Open Surgery Controls from the Premier Perspective Database." Journal of Endourology. Online article access

2013 Pilecki MA, McGuire BB, Jain UK, Kim J and Nadler RB "National multi-institutional comparison of 30-day post-operative complication and re-admission rates between open retropubic radical prostatectomy (RRP) and robot-assisted laparoscopic prostatectomy (RALRP) using NSQIP." Journal of Endourology. Online article access

2013 Liu JJ, Maxwell BG, Panousis P and Chung BI "Perioperative Outcomes for Laparoscopic and Robotic Compared With Open Prostatectomy Using the National Surgical Quality Improvement Program (NSQIP) Database." Urology 82(3): 579-83. Online article access

2013 Moran PS, O'Neill M, Teljeur C, Flattery M, Murphy LA, Smith G and Ryan M "Robot-assisted radical prostatectomy compared with open and laparoscopic approaches: A systematic review and meta-analysis." International Journal of Urology 20(3): 312-21. Online article access

2010 Coelho RF, Rocco B, Patel MB, Orvieto MA, Chauhan S, Ficarra V, Melegari S, Palmer KJ and Patel VR "Retropubic, Laparoscopic, and Robot-Assisted Radical Prostatectomy: A Critical Review of Outcomes Reported by High-Volume Centers." Journal of Endourology. Online article access

2010 Cooperberg MR, Vickers AJ, Broering JM and Carroll PR "Comparative risk-adjusted mortality outcomes after primary surgery, radiotherapy, or androgen-deprivation therapy for localized prostate cancer." Cancer. Online article access

2009 Ficarra V, Novara G, Fracalanza S, D'Elia C, Secco S, Iafrate M, Cavalleri S and Artibani W "A prospective, non-randomized trial comparing robot-assisted laparoscopic and retropubic radical prostatectomy in one European institution." BJU International 104(4): 534-9. Online article access

Partial Nephrectomy (1)

2009 Benway BM, Bhayani SB, Rogers CG, Dulabon LM, Patel MN, Lipkin M, Wang AJ and Stifelman MD "Robot Assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy for Renal Tumors: A Multi-Institutional Analysis of Perioperative Outcomes." Journal of Urology. Online article access

Cystectomy (2)

2011 Lee R, Chughtai B, Herman M, Shariat SF and Scherr DS "Cost-analysis comparison of robot-assisted laparoscopic radical cystectomy (RC) vs open RC." BJU International 108(6 B): 976-983. Online article access

2009 Nix J, Smith A, Kurpad R, Nielsen ME, Wallen EM and Pruthi RS "Prospective Randomized Controlled Trial of Robotic versus Open Radical Cystectomy for Bladder Cancer: Perioperative and Pathologic Results." European Urology. Online article access

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.

Level of Evidence of Peer-Reviewed Publications

The table below summarizes the level of scientific evidence for the clinical publications related to da VinciUrology Surgery. These levels of evidence are adapted from the March 2009 Centre for Evidence Based Medicine levels of evidence.

LEVEL	DESCRIPTION	New in 4th Quarter	Total
Level 1
1a	Systemic reviews of randomized controlled trials		0
1b	Randomized controlled trials		3
1c	Randomized controlled trials for robotic technique studies		8
Level 2
2a	Systematic reviews of only comparison studies and Independent database population studies	9	63
2b	Prospective non-randomized studies and RCTs with N<20	3	57
Level 3
3a	Systematic reviews of mixed studies (comparison and single arm)	5	18
3b	Retrospective non-randomized studies and prospective comparison studies with N<20	26	372
Level 4
4a	Literature reviews	5	17
4b	Single arm studies and retrospective comparison studies with N<20	59	972
Level 5	Case reports, Animal and Cadaver studies, Expert Opinion and Editorials	72	1599
TOTAL		179	3109

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.

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PN 1005333 Rev B 2/14

All surgery presents risk, including da Vinci^® Surgery and other minimally invasive procedures. Serious complications may occur in any surgery, up to and including death. Examples of serious or life-threatening complications which may require hospitalization include injury to tissues or organs, bleeding, infection or internal scarring that can cause long-lasting dysfunction or pain. Temporary pain or nerve injury has been linked to the inverted position often used during abdominal and pelvic surgery. Risks of surgery also include potential for equipment failure and human error. Risks specific to minimally invasive surgery may include: A long operation and time under anesthesia, conversion to another technique or the need for additional or larger incisions. If your surgeon needs to convert the procedure, it could mean a long operative time with additional time under anesthesia and increased complications. Temporary pain or discomfort may result from pneumoperitoneum, the presence of air or gas in the abdominal cavity used by surgeons in minimally invasive surgery. Research suggests that there could be an increased risk of incision-site hernia with single-incision surgery. Results, including cosmetic results, may vary. Patients who bleed easily, who have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci^® Surgery. For more complete information on surgical risks, safety, and indications for use, please refer to http://www.davincisurgery.com/safety/. Patients should talk to their doctors about their surgical experience and to decide if da VinciSurgery is right for them. Other options may be available. Intuitive Surgical reviews clinical literature from the highest level of evidence available to provide benefit and risk information about use of the da Vinci Surgical System in specific representative procedures. We encourage patients and physicians to review all available information on surgical options and treatment in order to make an informed decision. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed.