Clinical Evidence - GeneralSurgery

General Surgery - 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® General Surgery.

Cholecystectomy   (2)

2012 Spinoglio, G., F. Priora, et al. "Real-time near-infrared (NIR) fluorescent cholangiography in single-site robotic cholecystectomy (SSRC): a single-institutional prospective study." Surgical Endoscopy: 1-7 Online article access

2010 Angus, A. A., S. L. Sahi, et al. "Learning curve and early clinical outcomes for a robotic surgery novice performing robotic single site cholecystectomy." Int J Med Robot Online article access

Colorectal    (7)

2014 Hellan, M., G. Spinoglio, et al. "The influence of fluorescence imaging on the location of bowel transection during robotic left-sided colorectal surgery." Surgical endoscopy: Online article access

2013 Baek, S. K., J. C. Carmichael, et al. "Robotic surgery: colon and rectum." Cancer J 19(2): 140-146 Online article access

2013 Casillas Jr, M. A., S. W. Leichtle, et al. "Improved perioperative and short-term outcomes of robotic versus conventional laparoscopic colorectal operations." American Journal of Surgery   Online article access

2013 Jafari, M. D. L., K. H.; Halabi, W. J.; Mills, S. D.; Carmichael, J. C.; Stamos, M. J.; Pigazzi, A. "The use of indocyanine green fluorescence to assess anastomotic perfusion during robotic assisted laparoscopic rectal surgery." Surgical Endoscopy: 1-6   Online article access

2013 Juo, Y. Y., O. Hyder, et al. "Is Minimally Invasive Colon Resection Better Than Traditional Approaches?: First Comprehensive National Examination With Propensity Score Matching." JAMA Surg Online article access

2013 Morpurgo E, Contardo T, Molaro R, Zerbinati A, Orsini C and D'Annibale A "Robotic-assisted intracorporeal anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy for cancer: a case control study." Journal of Laparoendoscopic and Advanced Surgical Techniques. Part A 23(5): 414-7 Online article access

2012 Kang, J. Y., K. J.; Min, B. S.; Hur, H.; Baik, S. H.; Kim, N. K.; Lee, K. Y. "The impact of robotic surgery for mid and low rectal cancer: A case-matched analysis of 3-arm comparison--open, laparoscopic, and robotic surgery." Annals of Surgery   Online article access

Gastrectomy          (1)

2013 Marano, A., Y. Y. Choi, et al. "Robotic versus Laparoscopic versus Open Gastrectomy: A Meta-Analysis." J Gastric Cancer 13(3): 136-148   Online article access

Bariatric      (1)

2011 Hagen, M. E. P., F.; Chassot, G.; Huber, O.; Buchs, N.; Iranmanesh, P.; Morel, P. "Reducing Cost of Surgery by Avoiding Complications: the Model of Robotic Roux-en-Y Gastric Bypass." Obesity Surgery: 1-10    Online article access

Pancreas      (2)

2013 Zhang, J., W. M. Wu, et al. "Robotic versus open pancreatectomy: a systematic review and meta-analysis." Ann Surg Oncol 20(6): 1774-1780   Online article access

2012 Daouadi, M. Z., A. H.; Zenati, M. S.; Choudry, H.; Tsung, A.; Bartlett, D. L.; Hughes, S. J.; Lee, K. K.; James Moser, A.; Zeh, H. J. "Robot-assisted minimally invasive distal pancreatectomy is superior to the laparoscopic technique." Annals of Surgery   Online article access

Level of Evidence of Peer-Reviewed Publications

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

LEVEL	DESCRIPTION	New in September	Total
Level 1
1a	Systemic reviews of randomized controlled trials		2
1b	Randomized controlled trials	1	7
1c	Randomized controlled trials for robotic technique studies		0
Level 2
2a	Systematic reviews of only comparison studies and Independent database population studies	10	20
2b	Prospective non-randomized studies and RCTs with N<20	1	13
Level 3
3a	Systematic reviews of mixed studies (comparison and single arm)	4	22
3b	Retrospective non-randomized studies and prospective comparison studies with N<20	9	136
Level 4
4a	Literature reviews	8	20
4b	Single arm studies and retrospective comparison studies with N<20	15	214
Level 5	Case reports, Animal and Cadaver studies, Expert Opinion and Editorials	32	577
TOTAL		80	1011

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 1005335 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 Vinci Surgery 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.