Thursday, March 08, 2007

Rare but often serious complications continue to plague the most common laparoscopic operation.

Hidden Risks
March 12, 2007 issue - When surgeons removed Carol Hurlburt's diseased gallbladder in 2005, they had to cut a long, gory incision in her abdomen, and she was still hurting when her husband developed his own gallbladder infection a month later. Richard Hurlburt, however, was a candidate for a less painful, minimally invasive procedure performed with the aid of cameras inserted through small holes in his abdomen—a "laparoscopic cholecystectomy" that would have him home the next day. But, Carol says, Richard's common bile duct, which links the gallbladder, liver and small intestine, was cut. Over the next eight months, Richard became sicker and died waiting for a liver transplant. What was supposed to be a simple procedure ended in tragedy. Determining what caused it all, and where it went wrong, has moved from the hands of doctors to the hands of lawyers. Last summer, Carol filed suit.
One of the most common surgical procedures in the country, performed on 750,000 patients annually, laparoscopic gallbladder removal has a record of success stretching back almost two decades. Serious complications are rare; less than 1 percent of patients die. Along with other surgeries that rely on scopes as well as scalpels—including gastric bypass, hernia repair and appendectomies—the "lap chole" has largely supplanted open operations, helping millions of patients avoid long and potentially dangerous recoveries in hospitals. "Minimally invasive surgery was a revolution," says California Pacific Medical Center's Leonard Shlain, who was one of the first to perform it.
But some doctors now say the demands of an overeager public have pushed them over the years into doing minimally invasive procedures before they had the necessary skills. In the rush, says Ram Chuttani of Beth Israel Deaconess Medical Center in Boston, "major complications occurred which might have been prevented." Shlain says some laparoscopic operations have "a dark side" of rare but serious complications, and that patients go into them falsely believing they are more or less risk-free. As doctors begin to perform new minimally invasive operations that seemed unthinkable a few years ago—including one that involves no skin incision at all—there is a danger that they, too, will overlook risks that have been there all along.
The first minimally invasive procedure to gain wide acceptance, the laparoscopic cholecystectomy arrived in the 1990s "like a thunderbolt," says Josef Fischer, chair of surgery at Beth Israel Deaconess Medical Center. Surgeons quickly adopted it as the standard of care for gallbladder infections, practicing on pigs at weekend workshops and then quickly moving on to human patients who lined up for it—even some whose problems were too mild to warrant open operations. Though popular with both docs and patients, the operation carried new risks, some more severe and more common than those of the procedure it was replacing. Most serious was the rising rate of injury to the common bile duct, at least five times higher than it was in open surgery. Most doctors, however, blamed this on the inevitable awkwardness of novices. The learning curve, they thought, would flatten out with time, and the operation would become safer.
Since then, the tools of minimally invasive surgery have improved greatly; today's equipment includes high-definition cameras and rotating scopes and lights that put the anatomy "right up in your face," says Ed Phillips of Cedars-Sinai Medical Center in Los Angeles. Surgeons have adopted preventive measures, such as X-rays that offer clear views of the common bile duct. They also now have experience with other minimally invasive procedures to treat heart failure, obesity and other ailments. Not all of them are better than their open counterparts, but overall, says Tom Russell, executive director of the American College of Surgeons, "pretty much everything in surgery is going this way."
Amid the promising changes, though, a troubling fact: the learning curve for laparoscopic cholecystectomies never flattened out. Just as in the '90s, in almost one out of every 200 cases, the surgeon cuts the common bile duct. That's nearly 4,000 patients per year. And the number may be underreported, says Shlain, because "few surgeons rush to tell people about their catastrophes." At conferences, he adds, he hears of more dire outcomes from laparoscopic gallbladder removal than the statistics suggest.
Read the rest of this Newsweek article

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