Chicago Tribune examines spread of robotic surgery “despite inconclusive evidence”

Trine Tsouderos of the Chicago Tribune published a noteworthy story, “Remote-control surgery grows, despite inconclusive evidence.”  Excerpts:

Intuitive Surgical is a medical sensation, transforming surgery in some fields, especially gynecology and urology, in about a decade. More than 250,000 hysterectomies and prostate removal surgeries were done with the da Vinci last year, according to the company. Surgeons are expanding use of the machines to other procedures, from gastric bypasses to thyroid cancer surgeries. Advocates of the devices say they make minimally invasive surgery possible for more patients, helping them recover more quickly and in less pain.

But patients wondering whether they should opt for robot-assisted surgery should be aware that the choice is sometimes more complex than the messages presented by hospitals and the company.

Despite a flood of scientific papers associated with the da Vinci, there is a dearth of randomized, controlled studies showing patients do best if procedures are performed with the da Vinci. Federal oversight of medical devices such as the da Vinci is light. There have been voluntary recalls — more than a dozen since 2005 — involving problems with software and surgical instruments. Lawsuits have helped raise concerns that some surgeons are using the devices before the doctors are adequately trained.

This month, a jury awarded a Chicago man’s family $7.5 million after he died following a robot-assisted removal of his spleen in 2007 at the University of Illinois Hospital. Neither the hospital nor Intuitive was named as a defendant in the lawsuit. The family alleged that the man’s small intestine was punctured twice during surgery, causing a fatal infection.

The man’s surgeon testified it was the first time he had used the robot on a living person, according to court documents.

“The robot is the symbol of the current American health care marketplace — rapid widespread adoption with little to no evidence to support it and increased costs,” said Dr. Martin Makary, a surgeon at Johns Hopkins School of Medicine and author of a study of 400 hospital websites that found they were making unsupported claims about robot-assisted surgery.

She also includes a sidebar on “What to ask your surgeon“:

Here are some questions patients should ask their surgeon when considering a robot-assisted procedure:

•When did you do your first robot-assisted procedure? How were you trained? How many robot-assisted cases have you done? How often do you do them? How many robot-assisted cases have you done of my procedure?

•Are you more comfortable doing this type of procedure laparoscopically, robot-assisted or the traditional open approach? What are the pros and cons of each?

•What happens if the robot malfunctions during surgery or you have to convert to open surgery? How many open cases of my procedure have you performed? How often do you do them?

•What kind of training on the da Vinci do the nurses and other surgeons in the operating room get? How experienced are they? How experienced are they in converting to an open procedure mid-surgery?

•Will you be mentoring another surgeon during my procedure? Will he or she be doing any of it? If so, how many cases has he or she performed?