SAN FRANCISCO — For patients undergoing Roux-en-Y gastric bypass surgery, concurrent cholecystectomy or treatment with ursodiol is more cost-effective than leaving patients alone and waiting to see if they develop gallstones, Dr. Brent C. White reported.
The combined intervention also provides a better quality of life, according to an analysis that he presented at the annual clinical congress of the American College of Surgeons.
Dr. White and his colleagues performed a cost analysis that compared three treatment strategies for patients undergoing Roux-en-Y gastric bypass surgery: Giving ursodiol treatment for 6 months post operatively, performing concurrent cholecystectomy, and watchful waiting for possible gallstones. The analysis assumed that patients who developed gallstones during watchful waiting or while being treated with ursodiol would undergo cholecystectomy.
After culling information from the peer-reviewed literature, the investigators incorporated into the analysis data on the likelihood of a patient developing gallstones after a Roux-en-Y bypass, on the effectiveness of ursodiol treatment, and on the likelihood of complications with any of the strategies.
In their payer-perspective analysis, the investigators found that concurrent cholecystectomy was the least expensive treatment, with an average cost of $1,046 per patient, followed by ursodiol at $2,623 and watchful waiting at $3,964, said Dr. White of the surgery department at Dartmouth Hitchcock Medical Center, Lebanon, N.H.
The three treatments showed almost the same number of quality-adjusted life-years achieved: 21.39 years for concurrent cholecystectomy, 21.44 years for ursodiol, and 21.43 years for watchful waiting.
When the cost per quality-adjusted life-year of watchful waiting was computed for a population of patients, it was found to exceed the benchmark of what is considered a cost-effective strategy. Ursodiol, on the other hand, was cost-effective, as long as one considered it to be at least 60% effective in preventing gallstones.
On the basis of these findings, Dr. White and his associates concluded that “surgeons who currently employ a watchful waiting approach should consider either using ursodiol or performing a concurrent cholecystectomy.”
Studies have suggested that anywhere from 32% to 71% of patients who have a Roux-en-Y bypass will develop gallstones, he noted.
In a 2002 survey of surgeons who perform bariatric procedures, 30% said they use ursodiol treatment after a Roux-en-Y procedure, 15% remove the gallbladder routinely, and the remainder watch and wait, Dr. White said.
The landmark clinical trial of ursodiol treatment found that it reduced the rate of gallstone formation to 2%, from 32% in untreated controls.
In commenting on the analysis, Dr. David Flum said he thought the study was a timely piece of work, given the variations in practice, but that physicians perhaps should not put too much stock in a study that looked at the issues primarily from a cost perspective.
“We have to be very careful about the message we are sending when you only look at cost and quality-adjusted life-years,” said Dr. Flum of the University of Washington, Seattle. Bile duct injury may occur with gallbladder removal, and it has a devastating impact on the patient, he cautioned. And the situation may be changing as more procedures are done laparoscopically, when removing the gallbladder is more difficult.
Moreover, it is not clear how effective ursodiol treatment is, even when patients are compliant. Studies have shown that patients dislike taking it so much that at least half of them stop.
“I think that a lot of people will take this study and interpret it in different ways,” Dr. Flum added.