As use of robotic surgery increases, training and regulation become more rigorous

Robotic-assisted surgery has served as an alternative minimally invasive surgical option for patients with cancer for more than a decade.

The smaller incisions required for robotic and laparoscopic surgeries than traditional open surgery result in reduced infection risk, shorter hospitalization, and less pain and discomfort.

“Robotics emerged as a technology in the 2000s. Over the last several years there has been a growth of both laparoscopic and robotic surgical applications to make patients’ recovery less painful,” John J. Moynihan, MD, FACS, surgeon and chair of the department of surgery at Inova Fairfax Medical Campus, said in an interview with HemOnc Today. “There is no question there is a benefit in terms of postoperative pain due to the smaller incisions.”

Source: Debra Troell, Inova Health System.

Despite these benefits, research has not yet shown a dramatic difference in outcomes for robotic-assisted surgery compared with a standard laparoscopic approach.

Robotic-assisted surgery is a costly investment for health care organizations. The average cost of the da Vinci Surgical System (Intuitive Surgical) — the leading robot in the industry — is $2 million, with additional annual maintenance fees.

“Any new technology often has added costs, which an institution weighs carefully when making the decision to move forward with it,” Moynihan said. “These costs include not only the device or technology itself, but also the implementation and training necessary for its safe application to patient care.”

Despite the costs, the benefits of robotic-assisted surgery — and its marketability to patients — have led institutions worldwide to invest in this technology.

HemOnc Today spoke with surgeons and researchers about the growth of robotic-assisted surgery, the advantages it offers patients, the role marketing may play in influencing patients’ surgical choices, and how robotic-assisted surgery may change the surgical landscape.

Benefits of the bots

The da Vinci Si system — FDA approved for surgical use in 2000 — is commonly used for prostatectomies, and increasingly for gynecologic surgical procedures.

“Instead of huge abdominal or chest cuts, we can perform more laparoscopic surgeries using these robotic platforms,” Mario M. Leitao, Jr., MD,FACOG, FACS, attending surgeon and director of the minimal access and robotic surgery program at Memorial Sloan Kettering Cancer Center, told HemOnc Today. “The goal is to continue to do the same quality cancer surgery, but with reduced complication rate, shorter length of hospitalization and quicker recovery.”

These outcomes stem from the fact that the robotic platform simplifies the procedure for surgeons.

“Laparoscopic surgery is like wearing a cast on your wrist, whereas with robotic surgery, that cast is removed,” Jim C. Hu, MD, MPH, professor of urologic oncology at Weill Cornell Medicine, told HemOnc Today.

Precision — a key for all types of surgery — has improved with robotics.

“The most important benefit of this tool is more precision to perform surgery,” Khurshid A. Guru, MD, director of robotic surgery at Roswell Park Comprehensive Cancer Center, said in an interview. “Another big advantage is less blood loss, especially for gynecologic surgery. You have a lot of organs squished together, so it is more precise and neater to use the robotic platform.”

However, robotic-assisted surgery is not meant to directly impact cancer outcomes.

“Its effect is less in terms of diagnosis and more in terms of the ability of a patient to have less invasive surgery, a smaller incision and a less uncomfortable recovery,” Moynihan said.

The robotic platform can be used for a variety of cancer and noncancer surgeries. Although the benefits are clear compared with open surgeries, they have been more difficult to document compared with laparoscopic surgery.

“For operations for which you don’t have another minimally invasive procedure that’s widely used — like for prostatectomy — there tends to be greater benefit to robotic-assisted surgery in contrast to those procedures where there is already an accepted procedure,” Jason D. Wright, MD, chief of the division of gynecologic oncology at Columbia University Medical Center and Sol Goldman associate professor of gynecologic oncology at Columbia University College of Physicians and Surgeons, told HemOnc Today. “In those cases, the potential benefits of robotic-assisted surgery tend to be less.”

The prostate is located in a particularly hard-to-reach area in the body, making it more difficult for a surgeon to reach and treat laparoscopically.

Porpiglia and colleagues found robotic-assisted radical prostatectomy yielded higher rates of postoperative continence and potency than laparoscopic radical prostatectomy in a cohort of 120 men with organ-confined prostate cancer.

Researchers compared functional, perioperative and oncologic outcomes among patients randomly assigned robot-assisted radical prostatectomy or laparoscopic radical prostatectomy. They observed a higher rate of continence among men assigned the robotic procedure at 3 months (80% vs. 61.6%; P = .044) and 1 year (95% vs. 83.3%; P = .042).

Among patients who were potent before the operation and who were treated with nerve-sparing techniques, erection recovery was 80% among those assigned the robotic procedure and 54.2% among those assigned the laparoscopic approach (P = .02).

“The robot allows a surgeon to get very close to the organ,” Clint D. Bahler, MS, MD, assistant professor of Urology at Indiana University School of Medicine, said in an interview. “The prostate itself is fairly small and doesn’t have a lot of movement within the body, so it really lends itself to a robotic removal.”

Negative trials

The benefits of the robotic surgery have not been consistently demonstrated across cancer types.

Bochner and colleagues found patients with bladder cancer who underwent robotic-assisted laparoscopic radical cystectomy via the da Vinci platform had similar complication rates and length of hospital stays as patients who underwent open radical cystectomy, the standard surgery for bladder cancer.

In the trial, researchers randomly assigned 118 patients to open radical cystectomy (n = 58) or robotic-assisted radical cystectomy (n = 60).

On intention-to-treat analysis, researchers observed 62% of patients who underwent robotic-assisted surgery and 66% of patients who underwent open cystectomy experienced grade 2 to grade 5 complications (difference, –4 percentage points; 95% CI, –21 to 13). High-grade complications also occurred at similar rates between groups (22% vs. 21%).

Although the robot has been used for cystectomy, uptake in usage is far less than for robotic-assisted proctectomy.

“This makes sense to me because, when you are removing a bladder, you have to move other organs to reconstruct,” Bahler said. “Robots are really good when you can focus on one area, but it limits you in having broader field of view, which you need for other types of surgeries. The robot is better when you need to focus in one area, and the prostate is perfect for that.”

Laparoscopic surgery is commonly used for colon cancer, but its use is more controversial for rectal cancer. Clinical trials have yielded conflicting results about the procedure’s benefits.

The randomized ROLARR clinical trial assessed whether robotic-assisted laparoscopic surgery reduced risk for conversion to laparotomy compared with conventional laparoscopic surgery among patients with rectal cancer.

Jayne and colleagues randomly assigned 471 patients (mean age, 64.9 years) to robotic-assisted surgery (n = 237) or conventional laparoscopic surgery (n = 234), performed by either upper or total rectum anterior resection or rectum and perineum resection.

The rate of conversion to open laparotomy was 12.2% among patients assigned conventional laparoscopy and 8.1% among those assigned robotic-assisted laparoscopy. The circumferential resection margin positivity rate was 6.3% for conventional laparoscopy and 5.1% for robotic-assisted laparoscopy.

Researchers observed no significant differences in secondary outcomes between groups.

In another study, In Gab Jeong, MD, PhD, associate professor in the department of urology at Asan Medical Center in Seoul, South Korea, and visiting scholar at Stanford University, and colleagues determined robotic-assisted surgery was not superior to laparoscopic surgery for treatment of kidney cancer.

The analysis included 23,753 patients (mean age, 61.4 years; 58.1% men) who underwent laparoscopic surgery (n = 18,573) or robotic-assisted radical nephrectomy (n = 5,180) for renal mass.

Researchers observed no significant differences between robotic-assisted and laparoscopic radical nephrectomy for incidence of any postoperative complications (22.2% vs. 23.4%; difference, –1.2%; 95% CI, –5.4 to 3) or major complications (3.5% vs. 3.8%; difference = –0.3%; 95% CI, –1 to 0.5).

A greater proportion of patients who underwent robotic-assisted surgery had operating times longer than 4 hours (46.3% vs. 25.8%; risk difference, 20.5%; 95% CI, 14.2-26.8).

Although the initial evidence supporting the procedure for this indication was based largely on single-institution observational trials, robotic-assisted procedures accounted for 30% of nephrectomies in 2015.

“The development and use of [a] robotic platform might be helpful for patient care. However, scientific research on cost-effectiveness and safety has sometimes not been sufficiently conducted,” Jeong told HemOnc Today when the study was published. “For the patient, when choosing to receive robotic surgery, it is necessary to have enough consultation with the doctor and understand their advantages and disadvantages compared with the existing conventional laparoscopic surgery.”

Overall, benefit is based on the type of cancer and the approach to treatment.

“There are a number of patients who do better because they’ve had a minimally invasive approach to their cancer,” Moynihan said. “A patient with prostate, rectal or pelvic, or uterine cancer doesn’t do well when tumors have been removed minimally invasively, and robotics helped advanced it.”

Cost concerns

The annual number of total robotic cases increased by nearly 400% between 2007 and 2011, according to the Intuitive Surgical website.

As use increases, questions and concerns remain about the costs and overall benefit of robotic-assisted surgeries.

“People who criticize robotic surgery will say there is no randomized trial that proves it’s better,” Hu said. “It’s very difficult to say there is no proven benefit to robotic-assisted surgery compared with open surgery because of the pain patients have to go through with an open procedure.”

Costs associated with the robotic platform have been highlighted as a disadvantage.

“There are certainly significant fixed costs,” Wright said. “As far as individual surgical procedures, there is a fairly large [amount of] literature comparing the cost of robotic-assisted surgery to open surgical surgeries, or more transitional laparoscopic surgery. Outcomes from those studies are really highly variable depending on surgical procedure.”

For instance, in their nephrectomy study, Jeong and colleagues found robot-assisted surgery led to higher mean 90-day direct hospital costs ($19,530 vs. $16,851), attributed to operating room ($7,217 vs. $5,378) and supply costs ($4,876 vs. $3,891).

“The rapid increase in costly robotic surgery in lieu of laparoscopic surgery without a definite advantage for the patient is a problem that can be applied not only to the urological field but also to the entire surgical field,” Jeong told HemOnc Today. “This may lead to a huge increase in the cost of medical care that can be a significant burden on the health care system and, thus, requires constant monitoring.”

The costs of robotic-assisted surgery are directly related to the rate of minimally invasive surgery, Leitao said.

“If you do 80% to 90% of all your cases laparoscopically without the robot, then you probably wouldn’t need a robot; but, that’s not the situation,” Leitao said. “Often, we see 5% to 20% are done with traditional laparoscopic surgery for most cancers. The robot has greatly augmented that.”

The rate of minimally invasive surgery at Memorial Sloan Kettering has increased tremendously for certain cancers solely because of the robotic platform, Leitao said.

“We have seen tremendously increased minimal invasive surgery rates while at the same time reducing complications and length of stay, which has led to reduced cost of surgical care,” Leitao said. “This is what you get when you look at it globally, as opposed to looking at the [multimillion-dollar] price tag of the platform in the beginning.”

Using a cost system to determine direct costs for patients who underwent surgery for uterine cancer between 2009 and 2010, Leitao and colleagues showed laparoscopy and robotic surgery were comparable in terms of costs if upfront costs were excluded, and both had lower costs than open surgery.

Of 436 cases — 132 laparoscopic procedures, 262 robotic-assisted surgeries and 42 laparotomies — the total mean amortized direct cost per case was $20,489 for laparoscopy, $23,646 for robotic-assisted surgery and $24,642 for laparotomy (robotics vs. laparoscopy, P < .05).

In another study of 426 obese women who underwent primary surgery at Memorial Sloan Kettering for newly diagnosed uterine cancer between 1993 and 2012, Leitao and colleagues found the robotic platform offered significant health and cost benefits by increasing minimally invasive surgery rates.

Of the cases, 299 were performed via laparotomy, 125 via minimally invasive surgery and two via a vaginal approach.

Researchers found use of minimally invasive surgery increased from 6% during 1993-2007 to 57% during 2008-2012 after the robot was introduced. In 2012, 78% of women in the cohort underwent minimally invasive surgery, 69% of which occurred with the robot.

The median length of hospital stay was 5 days (range, 2-37) for laparotomy cases and 1 day (range, 0-7) for minimally invasive surgery cases (P < .001). The complication rate was 36% for laparotomy cases and 15% for minimally invasive surgery cases (P < .001).

“The rate of complications for all patients went from 36% to 15%, and we recognized a cost savings of $7,000 per patient averaged throughout the entire group, including the cost of the robot,” Leitao said. “We were able to deliver safer surgery with no impact on cancer outcomes at a lower cost overall.”

Any technology does contribute to higher costs, according to Guru, especially since da Vinci was the only FDA-approved device.

“It does cost a lot of money and, because Intuitive [had been] the only approved device, there isn’t a lot of room for competitive pricing, so it becomes a health economics issue,” Guru said. “But, I do believe they will only evolve, and more options are on the horizon.”

In October, FDA approved Senhance System (TransEnterix Surgical), another robotic-assisted surgical device. However, not many urologists are using this method, Hu said.

“The reason why [the Senhance System] probably hasn’t been disseminated is there are so many places that already have the Intuitive system,” Hu said. “The question is, will this clearance make the da Vinci cheaper, or is there an opportunity to replace one when the older one isn’t working?”

New technology evolves through phases, Guru said, so it takes time to determine if one technology is better than another so it can be incorporated in day-to-day use.

“We are almost over that hump,” Guru said.

Experienced surgeons ultimately keep costs and length of hospital stay to a minimum.

“What we’ve learned over time is the dedicated teams who perform the surgeries on a routine basis are able to do it safely and quickly,” Moynihan said. “It comes down to that team’s training approach to these more surgically advanced techniques.”

Marketing, regulation

The increased use of robotic-assisted surgery also may be driven by consumerism.

Alkhateeb and colleagues found media coverage and marketing of robotic-assisted prostatectomy on the internet is more common than the other two procedures.

The researchers searched Google and Yahoo for the terms “robotic prostatectomy,” “laparoscopic prostatectomy” and “open radical prostatectomy.” They then evaluated website content for direct-to-consumer advertising from the first 50 websites displayed.

Results indicated direct-to-consumer advertising for robotic-assisted prostatectomy using Google was highest at 64%, compared with 16% for laparoscopic prostatectomy and 0% for open radical prostatectomy.

“There is absolutely no doubt that marketing plays a role,” Bahler said. “Companies also tend to cherry pick results, so it is easy to market anything. They just show the studies that are positive.”

There may be other factors at play, “but there is literature about market influences for patients and how it does impact their decision-making,” Wright said.

Finding the right surgeon, regardless of whether they perform robotic-assisted surgery, should remain the most important factor for patients, Leitao said.

“It’s not important to go find someone who does robotic surgery,” Leitao said. “It is important to find a surgeon who is great, who a patient is comfortable with and who does minimally invasive surgery at a high rate with or without a robot.”

Still, it is the surgeon’s responsibility to discuss all options with a patient who may be interested in robotic-assisted surgery to determine if it is the right approach.

“With appropriate patient selection — and, as is the case in any surgical procedure, the patient has a full understanding of the risks and benefits of the surgery — the robotic approach is now a reasonable technique in the realm of surgical oncology,” Moynihan said.

Researchers also have questioned whether the FDA’s regulations and testing for devices is rigorous enough.

Typically, new drugs are tested for safety and efficacy, and larger randomized controlled trials are conducted to determine their effectiveness against other drugs. There is no similar step-by-step process for device approvals, Wright said.

“A rigorous pathway is typically not feasible to perform for devices,” Wright said. “New procedures gradually diffuse into practice. When you look at the regulation of devices in the United States, it definitely has been questioned by many sources because of a lack of a rigorous pathway of testing.”

The IDEAL Collaboration — an initiative to improve the quality of research in surgery — established recommendations for a more step-wise progression for new devices and procedures before they are more widely used, with recommendations on specific study designs and reporting standards.

The Total Product Life Cycle (TPLC) database actively integrates premarket and postmarket data surrounding medical devices. It pulls information from FDA’s Center for Devices and Radiological Health databases on premarket approvals, premarket notifications, adverse events and recalls.

Pennell and colleagues conducted an expert consensus to determine how IDEAL might be modified to accommodate the needs of device regulation. TPLC, although largely supported, “lacks a template to define evidence requirements at different stages,” the researchers wrote.

Most experts agreed IDEAL could form an evidence template for a TPLC-based regulatory system after appropriate modifications, such as a new stage 0 to guide reporting of preclinical studies, expansion of registries to all stages, and omission of IDEAL stages 2 and 3 for “successor” devices under certain conditions.

Also, the FDA is developing more systematic programs to collect outcomes on devices both before approval and after to monitor for safety.

“They are moving toward a more rigorous evaluation of new procedures and devices,” Wright said.

The FDA is working with a network of collaborators to build NEST, or National Evaluation System for Health Technology, to collect real-world evidence for use in evaluating products.

“The point of this system is to reduce time and cost while increasing value and use of evidence derived from clinical practice,” FDA spokeswoman Stephanie Caccomo told HemOnc Today, adding that the FDA believes they demonstrate a “gold standard for demonstrating safety and effectiveness of medical products.”

Looking ahead

As the use of robotic surgery has increased, training has become an integral part of residencies.

“The fellowships are exposed to robotic and laparoscopic surgeries throughout the course of their fellowship and throughout many, if not all, surgical residencies now,” Moynihan said.

This is especially important due to the nuances of the robot.

“There is no touch and feel because of no tactile feedback,” Guru said. “[Because] you can’t feel what you are operating on, more training is needed.”

However, there is no national standard regarding the amount of training necessary, Bahler said.

“The American Board of Urology looks over your training and certifies you met required criteria for licensing, but the specific credentials to do robotic surgery come down to each individual hospital,” he said.

Training has improved over time, Guru said.

“Training also evolves,” Guru said. “Initially, we didn’t know what to train, but then we learned the strengths and weaknesses.”

As the use of robotic-assisted laparoscopic surgery steadily increases, there is a need to define a structured curriculum and credentialing process for professionals.

A review by Bahler and colleagues recommended:

• robotic training should include cognitive, psychomotor and teamwork/communication skills;
• simulation should be an integral part of robotic surgery curriculum; and
• assessments for certification and credentialing should not be based on the number of surgeries a surgeon performs, but on proven proficiency.

Guru agreed that simulation will become an integral part of robotics surgery.

“One of these days, it will happen,” Guru said. “It’s not that far away.”

Still, embracing the robotic surgery industry may open the door to more technological advances to help with surgery.

“The most exciting thing about robotic surgery for me is it has fluorescent imaging capabilities and, with the imaging, you now have the ability for tagging cancer,” Bahler said. “This has been seen in kidney cancer, but I think this will be coming up soon in prostate cancer. If you can inject a dye to make the cancer glow and a robot can show you that, that could be a big advance for cancer.”

Robotics are “not going away,” and surgeons should embrace that, Guru said.

“We shouldn’t be focusing on stopping the technology or reversing it, but rather on how to make it cheaper and better,” he said. “This is for the benefit of humanity.” – by Melinda Stevens

Click here to read the , “Is the cost of robotic-assisted surgery for cancer justifiable?”

References:

Alemzadeh H, et al. PLoS One. 2016;doi:10.1371/journal.pone.0151470.

Alkhateeb S and Lawrentschuk N. BJU Int. 2011;doi:10.1111/j.1464-410X.2011.10117.x.

Bahler CD, et al. Urol Clin N Am. 2014;doi:10.1016/j.ucl.2014.07.012.

Bochner BH, et al. N Engl J Med. 2014;doi:10.1056/NEJMc1405213.

Jayne D, et al. JAMA. 2017;doi:10.1001/jama.2017.7219.

Jeong IG, et al. JAMA. 2017;doi:10.1001/jama.2017.14586.

Leitao Jr. MM, et al. Obstet Gynecol. 2014;doi:10.1097/AOG.0000000000000223.

Leitao Jr. MM, et al. Ann Surg Oncol. 2016;doi:10.1245/s10434-015-5062-6.

Pennell CP, et al. Int J Surg. 2016;doi:10.1016/j.ijsu.2016.01.082.

Porpiglia F, et al. Eur Urol. 2012;doi:10.1016/j.eururo.2012.07.007.

For more information:

Clint D. Bahler, MS, MD, can be reached at cdbahler@iupui.edu.

Khurshid A. Guru, MD, can be reached at khurshid.guru@roswellpark.org.

Jim C. Hu, MD, MPH, can be reached at jch9011@med.cornell.edu.

Mario M. Leitao, Jr., MD, FACOG, FACS, can be reached at leitaom@mskcc.org.

John J. Moynihan, MD, FACS, can be reached at john.moynihan@inova.org.

Jason D. Wright, MD, can be reached at jw2459@cumc.columbia.edu.

Disclosures: Leitao reports an ad hoc consultant role with Intuitive Surgical. Bahler, Guru, Hu, Moynihan and Wright report no relevant financial disclosures.