Tuesday, May 11, 2010

Robotic Surgery Safety--Are Patients Part Of A "Learning Curve?"

Robotic or robot assisted surgery appears to be the latest surgical craze. Hospitals are purchasing these robots (known as the "de Vinci") to assist in heart, prostate, and gynecological surgeries, just to name a few. They are also spending lots of money marketing robotic surgery in billboards, TV, newspaper, and radio ads as a new breakthrough in "minimally invasive" surgery. However, a recent Wall Street Journal (WSJ) article has questioned whether certain hospitals and surgeons are qualified to offer robotic surgery as a safe alternative to traditional surgery.

The reason: there is a steep learning curve for the operator/surgeon to become proficient or experienced with the robot. Some surgeons quoted in the article indicated that it takes anywhere from 200-700 surgeries to become experienced enough to avoid certain surgical complications due to tecnical or operator error. And some smaller hospitals don't do nearly enough surgeries per year to allow surgeons to gain the necessary experience.

Here's the problem, according to the WSJ: many smaller hospitals have invested an initial $1.4 million in the machine, and may need to have 500 surgeries per year to make money on their investment. This raises an obvious question: is robotic surgery being "pushed" on patients in order to justify the use (and cost) of the machine?

Another potential problem is that there are no real standards as to when a surgeon is deemed qualified to safely operate the robot. Surgeons interested in robotic surgery are typically sent to a two day seminar where they operate on pigs and cadavers. Hospitals are free to set their own additional standards regarding operating under supervision (known as "proctoring"), but they are often minimal.

The article is worth a read because it highlights numerous misadventures/injuries with robotic surgeries, and hints that surgeon inexperience was the primary cause of patient injury. This issue sounds eerily similar to what happened when laparoscopic gallbladder (known as laparoscopic cholycystectomy or "lap chole") surgery was introduced in the late 1980's as the newest revolutionary breakthrough. Similarly, surgeons were sent to two or three day seminars and practiced on pig bladders, were supervised for a limited number of surgeries, and were deemed "proficient" in laparoscopic surgery.

The results were initiallly disasterous. The incidence of common bile duct injuries (a devastating injury to the main bile duct that is NOT supposed to be cut during gall bladder removal) increased dramatically versus the old fashioned "open" method of gall bladder removal. Numerous medical journals reporting these findings noted that the increase in common bile duct injuries was due to a "learning curve" caused by inexperienced surgeons as hospitals rushed to promote a new and better method of gall bladder removal. From personal experience, I investigated and litigated numerous Ohio laparscopic gall bladder malpractice cases where the patient's common bile duct was cut/severed, including a jury trial where the jury concluded that malpractice occurred and that the injury was preventable.

With the similar history of laparoscopic surgery in mind, patients inquiring about robotic surgery should ask the following questions of their hospital and surgeons:

1. How long has robotic surgery been in place at your hospital?
2. How many operations have been performed robotically at your hospital since this technology was introduced?
3. What are the surgeon's qualifications for performing robotic surgery?
4. What do your qualifications consist of?
5. How many robotic surgeries did you assist in?
6. How many have you performed on your own?
7. What specific complications have you encountered?
8. What is complication rate for your proposed surgery over and above the complication rate for traditional surgery?
9. Has the hospital published or kept track of the complication rate for robotic surgery and are those results available for review?
10. What are the latest leading studies, medical journal articles, papers, or abstracts regarding the safety or complication rates for your proposed surgery (and ask for a copy of the article or study)

If you don't receive any real answers to these basic questions, consider taking a pass on the de Vinci. Medical technology can be a wonderful thing. Indeed, laparoscopic bile duct injuries in lap gall bladder surgery have now essentially decreased very close to the level of injuries seen with traditional gall bladder surgery. But the lack of real testing and data with any new technology or surgery can put thousands of patients at risk for years until more is known about complication rates. Bottom line: you as a patient should not be an unknowing or unwilling guinea pig in any hospital's or surgeon's "learning curve."

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