A Word of Caution Regarding Robotic Surgical Procedures

robotic surgical procedures
robotic surgical procedures performing

It is clear that robotic surgery is superior to traditional “open” surgery, but…
Despite its availability for over twenty years, the extensive scientific research and literature on general surgical robots does not demonstrate better patient outcomes for most operations when compared to Laparoscopic surgical techniques.

For certain operations in the pelvis (prostate, uterus, anus or rectum), there is appreciable evidence to support that your time in the hospital (“length of stay”) and the possibility that the surgeon will have to abort the procedure and convert it to an open surgery, are better with a robot than Laparoscopic techniques. For operations in the abdomen and chest, that may not be the case at all.

Some surgeons and robot manufacturers may be adamant that robots are better because they offer advantages like “improved dexterity”, “motion scaling”, and “greater flexibility” but do you really care if none of those things translate into a longer, healthier, better life for you?

Surgical ApproachLaparoscopicOpen ApproachRobotic
Length of Hospital StayShortLongShort
Post-operative Pain & Opioid UseModerateHighModerate
Recovery timeShortLongShort
Complication RiskLowHighLow
Access to “Hard-to-reach” areasVery goodGoodExcellent
IncisionSeveral tinyLarge (invasive)Several tiny
Operating TimeModerateLongLongest
Long-term patient OutcomesExcellentExcellentExcellent
Time Under AnesthesiaModerateLongLongest
Short Term ComplicationsLowHighHighly dependent on surgeon experience

Surgical robots are becoming more and more common in operating rooms around the world. Robots for orthopedic and spine surgery are relatively new, but the “general” surgery robots have been around for more than two decades. This article will focus only on the “general” surgery robots which are used for a wide variety of procedures in the abdomen, pelvis, and chest, and whether they deliver superior patient outcomes when compared to other “minimally invasive” surgical approaches like “Laparoscopic” surgery.

“Open” surgery is the traditional ‘big incision, surgeon hands inside your body, lots of blood’ approach common throughout most of modern medical history up until the 1990’s. This approach is thankfully employed less and less every year.

A manually controlled robot performing surgery

“Laparoscopic” surgery uses tiny incisions, tiny cameras, and long thin instruments to reach through your skin and inside your body to fix diseased tissue. Think of it like trying to pick up a dumpling with chopsticks instead of using your fingers directly. Your surgeon is gowned and gloved standing right next to you, manipulating the camera and instruments to cut and sew using their own hands, which remain outside your body.

With general surgical robotic systems, your surgeon also uses tiny cameras and thin instruments, but instead of controlling them directly with their own hands, they use a robot to move the instruments and cameras while they sit at a video controller some distance from you the patient. Current clinical applications for general surgical robots include:

a) Urologic surgery, such as removal of the prostate gland, a kidney, or the urinary bladder.
b) Gynecologic surgery, including hysterectomy (uterus), myomectomy (for “fibroids”, sacrocolpopexy (pelvic prolapse surgery), removal of adhesive scar tissue, removal of the fallopian tubes and/or ovaries, and endometriosis surgery
c) Abdominal surgery, including bariatric (weight reduction) surgery, gastrectomy, gall bladder removal, removal of some portion of the pancreas, and hernia repair
d) Cardiac surgery including mitral valve repair and some aspects of heart “bypass” surgery.
e) Lung removal, complete or partial.
f) Colorectal Surgery
g) Head and neck surgery

Like Laparoscopic surgical approaches, robotic surgery is almost always superior to traditional “open” approaches. It should not be overlooked, however, that the length of your robotic operation, and the time you spend under anesthesia, can be more than twice as long as Laparoscopic surgery. It is clear that use of surgical robots can lead to injury or unexpected complications and the potential for poorer long-term outcomes, especially in the hands of less experienced surgeons. Like any other surgical tool, successful use of a robot is highly dependent on the surgeon’s skill and experience. I think we would all agree that not everyone who has a driver’s license is a good candidate to drive a race car.

In some cases, complications from a robotic procedure may not appear for years. The FDA noted in a 2019 Safety Communication, that there is potential for late-developing complications associated with surgical robot use for certain cancer-related surgeries.

So, why then, are surgical robots everywhere? Well, quite honestly, it’s because surgeons and hospitals think that you, the patient, want them. One way surgeons and hospitals compete for your business is by portraying themselves as sophisticated or “cutting edge”. Do not underestimate this! Hospitals spend billions of dollars annually on unproven technologies that sound good, just to keep patients and doctors coming to them. Robots sound so technologically advanced, they must be better, right?? Well, maybe…

Are there no controls for appropriate use of robots?

robotic-surgery remote

Patients benefit when hospitals (and more recently, ambulatory surgery centers) enforce rules for approving the application of surgical robots in new procedures, and for approving surgeons who are allowed to perform procedures robotically. Unfortunately, the fact is that many hospitals and Ambulatory Surgery Centers lack such disciplined approaches, and surgeons are often left to use their own judgement. Patient beware!

Advice to Patients

Patients should recognize that robotic procedures are not inherently better or worse than Laparoscopic surgery. Understand that surgical robots are a tool, and surgical outcomes depend on surgeon skill. The various surgical options available (open, Laparoscopic, robotic) all have trade-offs in terms of risks and benefits.

  1. Before consenting to a robotic operation, discuss with your surgeon the following issues as relates to robotic, laparoscopic, or open surgical option :
    a. The surgeon’s experience performing this operation with each of the three options (open, laparoscopic, robotic)
    b. The length of the procedure with each approach
    c. Complications associated with how the patient will be positioned during the procedure
    d. Possible procedural complications or inadvertent injuries caused by surgeons (e.g., nicking a blood vessel)
    e. Long-term complications (e.g., impact of scar tissue)
    f. Possible resolutions to the anticipated procedural risks
    g. Long-term patient outcomes
    h. The evidence base for the surgeon’s recommended approach. This one is really important! Don’t just accept when a surgeon says “In my hands, this is the best approach” or “I’ve done hundreds (or thousands) of these using a robot.” They may have done lots of surgeries with the robot, but that doesn’t mean it’s the best approach for your surgical needs. See the section below on “Clinical Evidence” to review some of the research conclusions about surgical robots.
  2. Be open to the possibility that another treatment approach, or another surgeon, might better align with your treatment goals.

Bad Stuff Can and Does Happen

intuitive-da-vinci-sp-surgical-system

In a study of 545 robotic surgery incidents reported by Pennsylvania hospitals over a 10-year period, 177 were classified as “serious events”—that is, incidents resulting in death (10 reports) or patient injury. Most of those incidents involved unintended lacerations/punctures, bleeding/hemorrhage, complications from patient positioning, retained foreign bodies, and infections (Pennsylvania Patient Safety Authority 2014).

In 2019, the FDA noted that complications from a robotic procedure may not become apparent until long after the surgery. In “Caution When Using Robotically-Assisted Surgical Devices in Women’s Health including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication”, the FDA stresses the need for caution, along with the need for research studies with longer follow-up times, when using surgical robots in innovative ways or for new procedures.

The communication states that “the FDA is concerned that health care providers and patients may not be aware that the safety and effectiveness of [robotically assisted surgical] devices has not been established for use in mastectomy procedures or the prevention or treatment of cancer.” It further states “To date, the FDA’s evaluation of robotically-assisted surgical devices has generally focused on determining whether the complication rate at 30 days is clinically comparable to other surgical techniques.

To evaluate robotically-assisted surgical devices for use in the prevention or treatment of cancer … the FDA anticipates these uses would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.”

Clinical Evidence

Below are some excerpts from other scientific publications to help illustrate that the value of general surgical robots is narrowly defined. Note that “minimally invasive” surgery is often shown to be superior to “open” surgery for the same surgical disease, but the evidence to support robotic surgery being superior to conventional minimally invasive “Laparoscopic” surgery is scant.

Bastawrous, A. L., et al. (2021). “A national database propensity score-matched comparison of minimally invasive and open colectomy for long-term opioid use.” Surgical Endoscopy.

Minimally invasive (Laparoscopic) colectomy is associated with a significant reduction in long-term opioid use when compared to OS (open surgery). Robotic-assisted colectomy was associated with less high-dose opioids compared to LS (Laparoscopic). Increasing adoption of minimally invasive surgery for colectomy and including RS (robotic), where appropriate, may decrease long-term opioid use.

Bittner Iv, J. G., et al. (2018). “Patient perceptions of acute pain and activity disruption following inguinal hernia repair: a propensity-matched comparison of robotic-assisted, laparoscopic, and open approaches.” Journal of Robotic Surgery: 1-8.

“Patient perceptions of pain and activity disruption differ by approach, suggesting a potential advantage of a minimally invasive technique over open for IHR.”

Rajaram, R., et al. (2020). “Postoperative opioid use after lobectomy for primary lung cancer: A propensity-matched analysis of premier hospital data.” Journal of Thoracic and Cardiovascular Surgery.

‘Patients undergoing RL (robotic surgery) for primary lung cancer received opioids less frequently, and with lower total and average daily doses, compared with those undergoing VATS (Laparoscopic) and open lobectomy.”

Shkolyar, E., et al. (2020). “Robotic-Assisted Radical Prostatectomy Associated With Decreased Persistent Postoperative Opioid Use.” Journal of Endourology.

“The risk of persistent opioid use was significantly lower among patients undergoing a robotic-assisted versus open approach.”

Batool, F., et al. (2018). “A Regional and National Database Comparison of Colorectal Outcomes.” JSLS : Journal of the Society of Laparoendoscopic Surgeons 22(4).

“Minimally invasive colorectal surgery is associated with fewer complications and has several other outcomes advantages compared with the traditional open approach.”

Rausa, E., et al. (2018). “Right hemicolectomy: a network meta-analysis comparing open, laparoscopic-assisted, total laparoscopic, and robotic approach.” Surgical Endoscopy.

“…short-term outcomes following RRH (robotic) and TLRH (totally laparoscopic) were superior to standard LRH (partial laparoscopic) and ORH (open).”

Waters, P. S., et al. (2019). “Successful patient orientated surgical outcomes in robotic versus laparoscopic right hemicolectomy for cancer – a systematic review.” Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland.

“Thirty-day morbidity and mortality was comparable between both approaches, with patients undergoing RRH(robotic) having significantly lower anastomotic complications, increased lymph node harvest, reduced length of stay, conversion to open and incisional hernia rates in a number of studies.”

Carbonell, A. M., et al. (2017). “Reducing Length of Stay Using a Robotic-assisted Approach for Retromuscular Ventral Hernia Repair: A Comparative Analysis From the Americas Hernia Society Quality Collaborative.” Annals of Surgery.

“Using real-world evidence, a robotic-assisted approach to RVHR offers the clinical benefit of reduced postoperative LOS (Patient Length of Stay in the Hospital) (Compared to open surgery).”

Chang, Y. S., et al. (2015). “A meta-analysis of robotic versus laparoscopic colectomy.” Journal of Surgical Research.

RC (robotic colectomy) can be performed safely and effectively with the number of lymph nodes extracted similar to LC (Laparoscopic colectomy).In addition, it can provide potential advantages of a shorter hospital stay, a shorter time to recovery of bowel function, and lower occurrence of postoperative complications. These findings seem to support the use of robotics for the minimally invasive surgical management of colectomy. However, RC had longer operating time.”

Dolejs, S. C., et al. (2016). “Laparoscopic versus robotic colectomy: a national surgical quality improvement project analysis.” Surgical Endoscopy and Other Interventional Techniques 31(6): 1-10.

“In a nationally representative sample comparing laparoscopic and robotic colectomies, the overall morbidity, serious morbidity, and mortality between groups are similar while length of stay was shorter by 0.5 days in the robotic colectomy group. Robotic LAR was associated with lower conversion rates and lower septic complications. However, robotic LAR is also associated with a significantly higher rate of diverting ostomy.”

Kneuertz, P. J., et al. (2018). “Robotic lobectomy has the greatest benefit in patients with marginal pulmonary function.” Journal of Cardiothoracic Surgery 13(1): 56.

“Robotic lobectomy has the potential to decrease the risk of postoperative pulmonary complication as compared with traditional open thoracotomy.”

Martin-Del-Campo, L. A., et al. (2017). “Comparative analysis of perioperative outcomes of robotic versus open transversus abdominis release.” Surgical Endoscopy.

Compared to open surgery “we found that the use of robotics was associated with decreased intraoperative blood loss, fewer systemic complications, shorter hospitalizations, and eliminated readmissions.”

Mäkelä-Kaikkonen, J., et al. (2019). “Cost-analysis and quality of life after laparoscopic and robotic ventral mesh rectopexy for posterior compartment prolapse: a randomized trial.” Techniques in Coloproctology.

“The effect on HRQoL (Health Related Quality of Life) is minor, with no differences between techniques.”

El Chaar, M., et al. (2019). “Cost analysis of robotic sleeve gastrectomy (R-SG)compared with laparoscopic sleeve gastrectomy (L-SG)in a single academic center: debunking a myth!” Surgery for Obesity and Related Diseases.

“Our study revealed no difference in cost R-SG (robotic) and L-SG (Laparoscopic), with a trend toward shorter length of stay for R-SG over time.”

Frequently Asked Questions

What is the argument against robotic surgery?

There is a risk of mechanical failure in robot-assisted surgery, in addition to the risk of human mistake when operating the robotic system. System components such as robotic arms, cameras, robotic towers, binocular lenses, and instruments, for example, can fail.

Is the FDA warning on robotic surgery?

The FDA reminds patients and health care providers that the safety and efficacy of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been demonstrated.

How safe is robotic laparoscopic surgery?

Infection risk is significantly minimised. This also means shorter hospital stays and speedier recuperation, as well as the patient being able to return to normal life much sooner. Robotic surgery is frequently minimally invasive, making it extremely safe.

Do you heal faster with robotic surgery?

Patients gain most from robotic surgery because they recuperate faster. Patients can resume normal activities sooner than with traditional open or laparoscopic surgery. Furthermore, robotic operations result in fewer surgical complications and smaller, less visible scars.

A Final Word…

Some operations should definitely be performed using a surgical robot. Surgeons with lots of experience using a surgical robot are more likely to deliver optimal results. But just because a surgeon recommends a robotic surgical approach, don’t assume that is superior to all else. Now that you have a better understanding of the risks and benefits of general surgical robots, use your new knowledge to have an informed discussion with your surgeon about the best surgical option for you.

Additional References and Resources

  1. Food and Drug Administration (FDA), U.S. Caution when using robotically-assisted surgical devices in women’s health including mastectomy and other cancer-related surgeries: FDA safety communication. 2019 Feb 28.
  2. Mulcahy N. Robotic mastectomy in US: starts, draws fire, st Potential disaster’ or evolutionary ‘next step’? Medscape 2019 Feb 7.
  3. Pennsylvania Patient Safety Authority. Robotic-assisted surgery: focus on training and credentialing. Pa Patient Saf Advis 2014 Sep;11(3):93-101.
  4. Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med 2018 Nov 15;379:1895-904. [For abstract, see: https://wwnejm.org/doi/10.1056/NEJMoa1806395.1
  5. Sheetz KH, Dimick JB. Is it time for safeguards in the adoption of robotic surgery? [Viewpoint). JAMA 2019 Apr 30;321(20):1971-2. [For abstract, see: https://jamanetwork.com/journals/jama/fullarticle/2732677.]
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