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The reported outcomes for the da Vinci robot have been disappointing, but a new study shows that surgeons can achieve expert-level results using the Morristown Protocol.
da Vinci training is taking on new meaning. For those who prefer using the robot over traditional laparoscopic surgery, the news over the past year has been less than positive. Unreported adverse effects, the cost of the robot, and doubts about surgical skill have been a concern to hospitals, medical professionals, and patients who have read negative reports.
Surgeons who have seen the benefits of da Vinci have been hoping for new studies that would showcase the advantages they claim to see firsthand, studies that prove that training surgeons results in measurably better outcomes. Well, now the data is in. Just last month, a new study out of the Icahn School of Medicine at Mount Sinai and Morristown Medical Center, called “the Morristown Protocol,” demonstrates that surgeons who followed its training protocol on a simulator perform at a much higher level than those who use the more traditional means of training for the da Vinci robot.
The study is the very first trial of a gynecological robotic simulation protocol that shows results in a live surgical environment. It also shows measurable improvement in clinical competency with live patients.
"Proficiency is something every novice robotic surgeon is looking for,” says study leader Patrick Culligan, MD, FACOG, FACS, division and fellowship director, Atlantic Urogynecology Associates, Morristown Medical Center. “Our study has found that surgeons can become ready much more quickly by using the simulator, potentially saving time, blood loss, and costs for each hospital robotic program."
Arnold Advincula, MD, vice-Chair of Women’s Health & Chief of Gynecology at Columbia University Medical Center, says that this is common sense-there is no question that training for the da Vinci is required. “Why would I want to have surgery with someone who isn’t ready? Why would I want anything other than an excellent surgeon doing my surgery? Either we’re excellent or we’re out.”
Since thousands of da Vinci robots have been purchased, the questions hospital administrators have been asking have to do with what kind of robotic training is necessary, how much is needed, and in what kind of setting.
The best type of training is also critiqued by the new study. “The current model for getting surgeons ready for surgery is a broken model,” Advincula insists. “But with this study, we know that we can train on a simulator and reach a high level of proficiency without sacrificing an animal. We also know that we can now do away with what is not working.”
The study shows that surgeons begin at different levels, and it may take a different path of commitments to gain competence on the robot. In other words, it proves that some surgeons need to work harder than others to gain proficiency. Some understand the mechanics of the robot right away, while others need more time on the simulator.
We have not seen a model showing competence in live surgery because such a model is logistically difficult, requiring necessary attention to scheduling, time, and effort. Culligan’s commitment to solving the question is appreciated by his peers. “This is the first study in gynecology that asks if simulation really improves performance in live surgery,” says Paul Tulikangas, MD, FACOG, FACS, an ob/gyn and urogynecologist affiliated with the University of Connecticut School of Medicine, who has adopted the new findings into his program. “Pat took it further than anyone when looking at expertise. He asked, ‘We think you’re better, but we don’t know for sure, so let’s examine live surgeries and see if the simulation program really improved performance.’”
What distinguishes this paper from previous studies is that it more carefully evaluates and then separates the various skill levels among the surgeons. “We used this study to set minimum skill levels that must be met before operating on live patients. This is important because surgeons develop their skills at different rates,” says Tulikangas. But in this latest study, the control group was experienced in robotics.
Surgeons who reviewed the study say it is the methodology that is different this time, because subjects are separated by skill level, which was not done in previous studies, such as the controversial 2013 JAMA study, which concluded that the surgical outcomes don’t justify the cost of the surgical robot.
John Lenihan, MD, who has publicly challenged studies based on poor methodologies, is also now using the Morristown protocol for new surgeons. He says the recent studies showing problems with the robot when compared with traditional laparoscopic surgery have been blown out of proportion. His remarks echo those of others who prefer the robot to standard laparoscopic surgery. “The da Vinci robot is not the problem,” he says. “Many of us have reviewed the literature. The number one cause of problems with the robot has to do with surgeons doing surgeries that they have not yet acquired the skills to do.” He claims that some surgeons have a lack of respect for the need for training in general.
This time, board-certified laparoscopic surgeons who had no prior experience with robotic surgery were, after the training, able to meet and even exceed the rigorous requirements of the study set by a team of experienced robotic surgeons who, according to researchers, averaged over 75 robotic cases each year. Study participants required between eight and 40 hours of simulation training to achieve the required benchmarks.
Culligan’s study involved 14 ob/gyns and two sets of comparative benchmarks. Its “expert surgeons” each performed supracervical hysterectomies, as did a group of “control surgeons.” The control group had full robotic hospital privileges but was not averaging more than two cases per month and had not trained on the simulator. Operating time, estimated blood loss, and a blinded skill assessment of videos were compared using t-tests for all cases across the three surgical groups.
Surgeons engaging in their first-ever robotic surgery, who used the training simulator, had a much better outcome than the control group, the investigators found. Compared with the control group, the surgeons trained with simulation completed their cases approximately 33% faster, had less blood loss, and scored better during the blind video review. Not only did the simulation-trained surgeons achieve the benchmarks set by the experts, they did so quickly. Each surgeon was required to reach expert status on the simulator before they could move to performing a human hysterectomy.
Champions of the robot want it to be available to surgeons because they believe that they should use the tools they like best. “We developed this simulation technology because we felt surgeons need easily accessible training outside of the operating room so that they can become comfortable and confident when using the robot” says Jeff Berkley, founder and CEO of Mimic Technologies, the company that designed the training platform for the da Vinci robot used in the study.
“The da Vinci robot is an enabling technology that allows surgeons to achieve expert levels of performance faster than with traditional laparoscopic surgery. This said, there is still a learning curve, and it is better to start climbing it before operating on patients.” Many surgeons believe that the robot is worth the cost if surgical outcomes are positive.
Does that mean we should allow each surgeon to operate using the tools that help he or she perform best regardless of cost? “The way I like to operate, with the robot or without, definitely plays a role in how surgery is performed,” says Tulikangas. But he insists that one of the important criteria that drive these decisions is cost data: “Quality outcomes are so important, but so is cost.”
Lenihan agrees that surgeons need to be honest with themselves and assess their own skills. “Not every surgeon can do every surgery.” Instead, because of overwhelming evidence in favor of patient safety, the goal for any surgeon should be a minimally invasive solution for the patient, a method for resolving the issue in the most expeditious way. After all, there are many ways to perform surgery. Lenihan says we need to rethink who is doing surgery, and how they are trained and evaluated. With fewer errors, we can be much more cost effective-and a lot safer.
The future of surgery is using a new method of training: group practice through simulation. Teamwork itself is new. Innovative studies such as Culligan’s will help pave the way for a group effort regarding safety and risk management around robotic surgery.
Tulikangas says they have incorporated the protocol into their training program, using Mimic’s technology. If a surgeon is doing a low volume of surgeries, he or she is now required to engage in the simulation training-and this is because of the study. “It’s a study a lot of people thought about doing. We’re very fortunate that Pat had the resources and commitment to do it.”