Clinical Evidence Company Home 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. As new technologies continue to impact healthcare outcomes and costs, evidence-based medicine and peer-reviewed clinical publications have become increasingly important. Evidence-based medicine relies on the results of clinical trials that study treatment options on a sampling of patients. The results or evidence help doctors, hospitals and governments to decide how to best care for patients. At Intuitive Surgical, our highest priority is and always has been to provide patient benefit by creating products that in a surgeon’s hands are safe, effective and minimally invasive. Intuitive Surgical tracks the creation and publication of peer-reviewed publications related to the da Vinci® Surgical System. The current library includes PubMed and Scopus-indexed publications that represent many surgical specialties; the vast majorities were researched and written independent of Intuitive. The da Vinci clinical library is increasing at a rate of over 125 publications per month. Since 1998, over 8000 peer-reviewed publications have appeared in various clinical journals on da Vinci Surgery. The table below summarizes the level of scientific evidence for the clinical publications related to da Vinci Surgery. These levels of evidence are adapted from the March 2009 Centre for Evidence Based Medicine levels of evidence. LEVEL DESCRIPTION New in 2Q 2014 Total Level 1 1a Systemic reviews of randomized controlled trials 2 4 1b Randomized controlled trials 1 16 1c Randomized controlled trials for robotic technique studies 5 22 Level 2 2a Systematic reviews of only comparison studies and Independent database population studies 18 150 2b Prospective non-randomized studies and RCTs with N<20 6 127 Level 3 3a Systematic reviews of mixed studies (comparison and single arm) 5 57 3b Retrospective non-randomized studies and prospective comparison studies with N<20 80 906 Level 4 4a Literature reviews 14 94 4b Single arm studies and retrospective comparison studies with N<20 136 2072 Level V Case reports, Animal and Cadaver studies, Expert Opinion and Editorials 247 4720 TOTAL 514 8168 Intuitive Surgical is pleased to highlight a bibliography of high level of evidence (level 1a, 1b and 2a) vs open surgery. Links to featured publications supporting the clinical effectiveness of da Vinci Surgery by specialties are listed below, as well as Level of Evidence definitions. * Urology * Gynecology * General Surgery * Cardiothoracic * Level of Evidence Definitions If you would like additional information, you can go to 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. Level of Evidence Definitions Level 1: 1a) Systematic reviews of Randomized Controlled Trials (RCT’s) 1b) Randomized Controlled Trials (RCT) 1c) RCT’s for robotic technique studies Level 2: 2a) Systematic reviews of comparison studies only or independent database population studies 2b) Prospective non-randomized studies and RCT’s that have N<20 (N=number of study participants) Level 3: 3a) Systematic reviews mixing both comparison and single-arm studies 3b) Retrospective non-randomized studies and prospective comparison studies that have N<20 Level 4: 4a) Literature reviews 4b) Single-arm studies and retrospective comparison studies that have N<20 Level 5: Case reports (single-arm studies with N<20) Animal and cadaver studies Bench research Expert opinion/editorial Bench Research: Research done in a controlled laboratory setting where non-human subjects are not being used. Comparison Studies: Combination of cohort studies and case-control studies. Literature Review (LR): Similar to systematic review with search criteria and process of extracting relevant data not clearly defined. A literature review may be more of an overview of a topic instead of focused on a single question or hypothesis similar to a systematic review. Meta-analysis: A meta-analysis is a systematic review of scientific literature that uses quantitative methods to synthesize and summarize the results. Prospective Comparison Study: A study in which all of the subject groups (study arms) are exposed to treatment prospectively after the initiation of the study. Randomized Controlled Trials (RCT): An epidemiological experiment in which subjects in a population are randomly allocated into groups, usually called study and control groups, to receive a treatment (such as robotic-assisted surgery) or a different treatment such as open surgery or intervention. The results are assessed by rigorous comparison of rates of disease, death, recovery, or other appropriate outcome in the study and control groups. Generally, a very small sample sized (N < 20) or heterogeneous patient populations will result in a lower quality study. Retrospective Comparison Study: A study in which at least one of the subject groups (study arms) is exposed to treatment prior to the initiation of the study (for example, prospective robotic cohort and retrospective open or lap cohort). Single-Arm Study: A group or series of case reports involving patients who were given similar treatment. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (for example, age, gender, ethnic origin) and information on diagnosis, treatment, response to treatment, and follow-up after treatment. (NCI Dictionary) [Also described as Case-Series Study] Systematic Review (SR): A systematic review is a summary of the scientific literature that uses explicit methods to perform a comprehensive literature search and critical appraisal of individual studies and that uses appropriate statistical techniques to combine these valid studies. Robotic Technique Study: A study comparing one type of robotic technique for a specific procedure versus a different type of robotic technique for the same procedure. Example of this would be a randomized study comparing different types of suturing for a specific robotic procedure. 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 http://www.intuitivesurgical.com/safety. Unless otherwise noted, all people depicted are models. © 2014 Intuitive Surgical. All rights reserved. All product names are trademarks or registered trademarks of their respective holders.