Medical technology is constantly evolving. As new medical devices are developed and existing devices are updated, clinical trials are conducted to confirm the technology is safe and provides the intended benefits to patients—sometimes over several years to reflect the technology’s long-term effects. As additional clinical trials progress and their results are published, the evidence surrounding a medical device’s safety and effectiveness can change over time, requiring health technology assessment organizations, such as ECRI, to revise their conclusions on the device.
Evidence-based medicine requires monitoring and analyzing available research to determine the safest and most effective treatment modalities. ECRI’s Clinical Evidence Assessment (CEA) helps healthcare institutions stay informed about advancements in medical technology to provide the best treatment for their patients.
One of the most rapidly growing specialties in surgery is robotic surgery, with many advancements made since the technology’s development in the 1980s. The surgical robot with the largest U.S. market share, predicted to continue to grow over the next 10 years, is da Vinci (Intuitive Surgical, Inc.). The da Vinci robot first gained FDA approval in 2000 and has evolved through different models over the past 23 years (da Vinci Si, X, Xi, and SP). As robotic surgery use has increased, the evidence surrounding da Vinci has grown through an increase in published case series and clinical studies; however, the high quantity of studies alone may not suffice to determine whether a technology is safe and effective. Rather, high-quality studies are often needed to draw clear conclusions on the device’s direct impact on specific patient outcomes (e.g., pain, function, quality of life, survival).
Over the past several years, ECRI has followed the growing evidence surrounding da Vinci and has performed a variety of rapid CEAs on the technology’s safety and effectiveness. In 2018, ECRI published three CEA reports on surgery with da Vinci for treating colorectal malignancies and nonmalignant colorectal and gynecologic conditions. At that time, our analysts deemed all three evidence assessments as inconclusive due to a lack of high-quality evidence. ECRI’s CEA reports, however, are updated periodically to reflect emerging evidence, so as more evidence became available on the da Vinci robot, we performed new CEAs.
ECRI’s most recent CEAs on da Vinci, published in 2023, focused on gynecologic and colorectal surgeries. These rapid assessments included only systematic reviews with meta-analyses (i.e., the best available evidence); however, the systematic reviews included few randomized controlled trials, and thus were found to be of low quality. However, the evidence still enabled lower-confidence conclusions for some outcomes in specific patient populations due to the consistency and clinically significant magnitude of reported effects. ECRI’s updated CEAs found the following:
- Surgery with da Vinci may reduce hospital length of stay compared with that of laparoscopic and open colon surgeries and open rectal surgeries. The evidence confirms this benefit for patients with cancer and nonmalignant disease (primarily diverticulitis) and was strongest in patients with rectal cancer.
- Surgery with da Vinci may result in better urologic and sexual function than laparoscopic surgery in patients with rectal cancer. Too few studies provided data to assess this benefit in other patient groups.
- Colorectal surgery with da Vinci may result in fewer conversions to open surgery than laparoscopic approaches. The evidence supports the benefit for benign and malignant disease, with a stronger benefit in patients with rectal cancer, but does not suggest a benefit for da Vinci over transanal rectal surgery in patients with cancer.
- Surgery with da Vinci may reduce mortality risk in patients undergoing anterior rectal resection for cancer. da Vinci performed better than open and laparoscopic surgery in this patient group. The evidence remains too limited to compare mortality with da Vinci and open or laparoscopic surgery for other patient groups.
- Surgery with da Vinci may reduce hospital length of stay compared with that of open gynecologic surgery and in certain patient populations compared with laparoscopic surgery. The evidence supported this benefit for hysterectomy with benign indication, confirmed no additional benefit in cervical and endometrial cancer and was too limited to draw conclusions on ovarian cancer.
- Surgery with da Vinci may reduce conversion to open surgery rates in benign gynecologic surgery as well as surgery for endometrial cancer compared with laparoscopic surgery. The evidence supported this benefit in patients undergoing hysterectomy and sacrocolpopexy but demonstrated no additional benefit with da Vinci for extrauterine endometriosis surgery.
- da Vinci surgery may reduce hospitalization time compared with that of laparoscopy for lymph node harvest in patients with gynecologic cancers. The evidence also indicates that conversion and complication rates were similar with both approaches in this patient group.
Impact on Acute vs Non-Acute Care Settings
While results may not be generalizable to all patient populations and most of the conclusions listed above do not pertain to patient-oriented outcomes, they still offer value for institutions considering implementing surgery with da Vinci. For example, acute care facilities concerned with reducing length of stay may find da Vinci to be a necessary investment; however, ambulatory surgery centers that do not provide overnight care may find that particular benefit of da Vinci not relevant to improving care at their facilities. On the other hand, ambulatory surgery centers concerned with reducing the number of cases requiring conversion to open surgery may find da Vinci to be a wise investment. Similarly, the additional data on specific patient groups may help optimize care delivery; for instance, a high-volume system offering both robotic and conventional surgery and looking to optimize da Vinci use may want to prioritize patients with rectal cancer based on the stronger evidence supporting da Vinci’s benefits for this group.
Evidence surrounding medical devices often changes over time. While it may take years for evidence on patient-oriented outcomes to emerge, other outcomes with shorter-term follow-up may still help healthcare institutions determine the best course of action surrounding a particular technology and treatment. Also, evidence may become more granular as it grows, teasing out information on what patient groups are more likely to benefit from the technology and enabling healthcare facilities to better tailor treatments to patient needs and to more wisely allocate resources. ECRI CEAs on the da Vinci robot illustrate the need for iterative evidence review in healthcare, and they provide important information that healthcare institutions can use to provide the best evidence-based care to their patients.
Learn how ECRI’s Clinical Evidence Assessment service provides unbiased evidence assessments on the most relevant published clinical literature to help improve patient care and schedule a complimentary consultation with one of our experts.