Who Should Operate? : Some Health Officials Favor Strict Curbs on Who Can Perform Procedure

Spurred by mounting reports of serious patient injury, health officials, hospitals and medical groups are recommending strict curbs on who can perform laparoscopic gallbladder surgery.

The New York state health department recently estimated a 2% incidence of serious injuries among laparoscopic cholecystectomy patients in New York due to surgical errors. It found seven deaths and a total of 223 serious injuries from the operation in more than 100 hospitals in the past two years. Several new injuries are reported every week.

The department estimated that half the complications are cuts to the common bile duct, a potentially fatal injury. Many of the rest were punctures of a major blood vessel, such as the aorta, or of an organ, such as the bowel, bladder or liver. All these are rare in conventional open surgery.

Surgeons at UC-San Diego have repaired 21 ductal injuries from the new operation in the last two years on referral from other centers, says David Easter, an assistant professor of surgery there. Cedars-Sinai is getting such referrals, too.

Laparoscopic novices incur a particularly high rate of ductal injuries. A major study last year of 1,518 operations found a 2.2% incidence of bile duct injury in the first 13 patients operated on by each participating surgical team. The rate dropped to 0.1% in subsequent patients, the same as the reported rate for open surgery.

The common duct is the major pipeline carrying bile, a vital digestive fluid, from the liver to the intestine. On the TV screen, surgeons can mistake it for the cystic duct, which flows into it and which must be cut to remove the gallbladder.

A cut or mistakenly clamped common duct can leak bile or become blocked, causing a painful and dangerous infection. Repairing an injured duct is difficult because of inflammation. The reconstructed duct frequently narrows, which can lead to chronic illness, liver failure and death.

Specialists say the injury almost never happens when the surgery is performed by a properly trained laparoscopist. If it does, the problem is usually recognized immediately and repaired without long-term consequences.

But a new nationwide study shows that half of laparoscopic cholecystectomy complications go undetected during surgery, far more than in the open procedure. A delay in treating complications often makes them more dangerous.

The New York health agency recommended that surgeons inform patients that laparoscopic cholecystectomy may pose additional risks compared to open cholecystectomy.

It also recommended that physicians seeking hospital approval to do the operation be board-certified surgeons qualified in biliary work. It said applicants should attend a training course with hands-on animal practice, assist an experienced laparoscopist in at last five human procedures, do at least 10 more under supervision and get further supervision after any serious errors.

These guidelines mirror those issued by the Society of American Gastrointestinal Endoscopic Surgeons in Los Angeles and by a growing number of hospitals.

Another precaution urged by the New York agency and leading surgeons is that, during the operation, surgeons should routinely take X-rays of the bile ducts to reduce the chance of cutting the wrong one and to spot problems early. This frequently isn’t done now.

This Is Band-Aid Surgery

During laparoscopic surgery, doctors insert a viewing device into a small incision in the abdomen. This device allows the medical team to watch its movements on a video monitor. The surgeon makes two or three other tiny incisions to insert instuments. In gall-bladder surgery, the incisions replace the six-inch cut traditionally needed to remove the organ.

WHAT CAN GO WRONG

Because laparoscopic incisions are so small and the surgeon’s view more limited, the surgical errors can include cutting the wrong blood vessels or, in the case of gallbladder surgery, improperly clamping the wrong bile ducts. The injuries can go undetected until symptoms, such as pain, occur.