By Marilynn Larkin
NEW YORK (Reuters Health) - 25/9/2019
Robotic gastrectomy is a complex procedure, and its significant learning curve can "substantially" affect surgical outcomes, a prospective study from Korea reveals.
To evaluate the complication-based learning curve and identify learning-associated complications of the technology, Dr. Sungsoo Park of the Korea University College of Medicine in Seoul and colleagues first planned to analyze 502 robotic gastrectomy cases done with the DaVinci Surgical System by five surgeons who had each performed at least 60 cases.
The decision to perform total or subtotal gastrectomy was based on the tumor location. Proficiency and mastery were defined as learning phases during which complication rates dropped below 11.9%, the average complication rate of robotic gastrectomy identified in the trial.
Because the learning curve did not plateau with 60 consecutive cases, the authors ultimately included only the three surgeons who had done at least 125 cases.
As reported online September 9 in Annals of Surgery, initial proficiency was observed, on average, after 25 cases, and the minimum operation time and learning curve plateau were reached at around 65 cases.
Specifically, the moderate complication rate (Clavien-Dindo Classification grade II or higher) was 20% in phase 1 (initial learning phase, cases 1-25), 10% in phase 2 (proficiency phase, cases 26-65), 26.1% in phase 3 (transitional or rebound phase, cases 66-88), and 6.4% in phase 4 (mastery phase, cases 89-125).
Previous experience on laparoscopic surgery and mode of training influenced progression in the learning curve.
Among the various complications, intra-abdominal bleeding and abdominal pain were identified as major learning-associated morbidities.
"This is the first study suggesting that technical immaturity substantially affects the surgical outcomes of robotic gastrectomy and that robotic gastrectomy is a complex procedure with a significant learning curve that has implications for physician training and credentialing," the authors conclude.
Dr. Paresh Shah, surgeon-in-chief and vice chair of quality and innovation in surgery at NYU Langone Health in New York City, told Reuters Health by email, "I agree with the assessment and think the findings are relevant to surgeons no matter where they practice. This group has nicely validated, using a prospective model, that there is a multiphasic learning curve associated with this kind of complex surgery."
"This study looks at the learning curve associated with robotic surgery for stomach cancer, (which) is different from a routine gastrectomy," he noted. "It is important not to conflate it with a sleeve gastrectomy, the most common form of stomach surgery for obesity."
"Because we don't have national standards or requirements for training surgeons in new technology, and it is adjudicated at the local level, at individual hospitals, there is a lot of variability in the type and extent of training the surgeons receive prior to using a technology," he said. "Many of our professional societies, like the American College of Surgery and the Society of American Gastrointestinal and Endoscopic Surgery, along with industry partners are trying to address some of the variations in training."
"It is very difficult to apply a simple numerical threshold to achievement of proficiency," he added. "While it is tempting to say, you need to do 25 cases, the reality is, some surgeons may achieve proficiency after 10, and some after 100, and some may never achieve proficiency."
"Whenever clinicians want to adopt a new technology, they should ask themselves, are they utilizing external training resources, internal training resources, proctorship, and mentorship appropriately? All of these together make for a comprehensive way to adopt new technology," he said.
"At NYU Langone, we have a formal structure for mentoring and proctorship that is ongoing, not finite, which I think is critical for responsibly adopting new technology," Dr. Shah concluded.
Surgical oncologist Dr. Anton Bilchik, chief of gastrointestinal research and of medicine at John Wayne Cancer Institute at Providence Saint John's Health Center in Santa Monica, also called the results "very relevant to the U.S."
"There is real concern in the U.S. that some procedures may be industry-driven without adequate training and oversight," he told Reuters Health by email. "It is far more important to perform a safe operation based on sound oncologic principles, regardless of the approach."
"More training either with simulations or in an animal laboratory is needed before surgeons embark on (robotic surgery)," he said. Like Dr. Shah, he noted that "close mentoring and supervision from experienced robotic surgeons are needed to assist those surgeons starting out."
"Finally," he said, "clinical trials are needed to determine whether the short- and long-term outcomes are similar to standard approaches."
Dr. Park did not respond to requests for a comment.
Ann Surg 2019.
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