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Clinical Evidence

Commitment to Evidence-Based Medicine

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 100 publications per month.

Level of Evidence of Peer-Reviewed Publications

Since 1998, over 7000 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 4th Quarter Total
Level 1  
1a Systemic reviews of randomized controlled trials   2
1b Randomized controlled trials 1 13
1c Randomized controlled trials for robotic technique studies   15
Level 2    
2a Systematic reviews of only comparison studies and Independent database population studies 26 115
2b Prospective non-randomized studies and RCTs with N<20 13 123
Level 3  
3a Systematic reviews of mixed studies (comparison and single arm) 10 43
3b Retrospective non-randomized studies and prospective comparison studies  with N<20 52 771
Level 4  
4a Literature reviews 17 63
4b Single arm studies and retrospective comparison studies with N<20 137 1857
Level V Case reports, Animal and Cadaver studies, Expert Opinion and Editorials 207 4335
TOTAL 465 7393

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

Clinical Research for da Vinci® Practitioners

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.

    PN 875634 Rev C 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.

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