Higher Risk Seen in New Form of Prostate Surgery
The leading form of prostate surgery--the most common major operation in older American men--may be associated with greater risk of death and complications than the older method it has eclipsed, according to an examination of the effectiveness of the surgery.
The surprising finding, published today in the New England Journal of Medicine, raises questions about transurethral resection of the prostate, a procedure widely believed to be safer than so-called open prostate surgery and done annually on nearly 400,000 men.
“What this article does is introduce a good deal of uncertainty about whether a common operation is as effective as people think,” said Dr. John E. Wennberg, a professor of epidemiology at Dartmouth Medical School and an author of the study.
About 379,000 transurethral resections were performed in the U.S. in 1987 as treatment for benign enlargement of the prostate, a gland in men that surrounds the neck of the bladder and the urethra and releases a substance that makes semen a liquid.
The gland becomes enlarged in as many as half of all men over age 50, often narrowing the urinary canal and obstructing the passage of urine from the bladder. If untreated, the condition can in some cases result in bladder and kidney damage.
Transurethral resection entails inserting a narrow tube into the penis and scraping away pieces of tissue from the enlarged gland. In the older, more invasive method, a surgeon cuts through the abdomen and removes the tissue using scissors or a scalpel.
That procedure, used in just 28,000 cases in 1987, has been supplanted in recent decades. The transurethral operation is considered less complicated and less risky; it requires less anesthesia and a shorter hospital stay.
(Cancer of the prostate is an unrelated condition that occurs in about 15% of men over 50. It is commonly treated with the open method or other surgery, radiation and drugs.)
The study, based on records of about 54,000 prostate surgeries in Europe and Canada, found that patients who underwent transurethral resection were much more likely to need a second prostate surgery in the following eight years than patients who had the older operation.
Twelve percent of the Danish transurethral resection patients studied underwent a second surgery, compared to 4.5% of their counterparts. In Manitoba, Canada, the corresponding numbers were 15.5% and 4.2%; in Oxfordshire, England, they were 12% and 1.8%.
The older procedure apparently allowed a more complete removal of tissue from the enlarged gland, the researchers said. They said the transurethral operation may also have caused damage to the urethra, requiring a subsequent operation.
Transurethral resection patients were also nearly 50% more likely than their counterparts to die during the four years after surgery. They were more than twice as likely to die of heart attack during that period than the patients who underwent open prostate surgery.
“These findings suggest that transurethral prostatectomy is less effective in overcoming urinary obstruction than the open operation,” the researchers wrote. They said the data also “raise the possibility that (the operation) may result in higher long-term mortality.”
Assessment of Risks
“It points out that a procedure which is probably the most common surgical procedure that males face, there are considerably more risks associated with it than is evident in the medical literature,” said co-author Noralou P. Roos of the University of Manitoba.
The researchers cautioned, however, that more research is needed to explore whether transurethral resections are a cause of the deaths--or whether the higher death rates might be traced instead to the kinds of patients selected for that operation.
For example, patients with heart disease or other illnesses may be more likely to undergo a transurethral resection because it is less invasive and less complicated than open surgery. They may die during the following years for reasons not directly related to the operation.
The researchers factored in the patients’ medical histories and still found the death rate appeared to be higher. But they acknowledged that a prospective study, following patients over time, would be needed to confirm the finding.
Dr. H. Logan Holtgrewe, treasurer of the American Urological Assn., said in an interview Wednesday that his association had “a hard time believing” the new findings. But he said the society has agreed to collaborate with Wennberg on a nationwide study that will follow prostate surgery patients over the next seven years.
Different Findings
Holtgrewe said the new findings differ sharply from two recent studies that found that only 0.2% of all transurethral resection patients died of the operation. Those studies, by urologists, followed 3,800 patients, but just for 90 days after the operation.
Holtgrewe urged that the risks of the operation not be exaggerated.
“The risks and dangers of leaving an obstructed prostate untreated are real, they are defined, they are not theoretical,” he said. Those risks should be weighed against the “theoretical possibility” raised by the new study, he said.
Some of the researchers, however, found a different moral in the study.
“I think it raises a question, and patients ought to discuss this with their urologists,” said Dr. David J. Malenka of Dartmouth. “People if they were given all the information about the options and which has risks might elect not to have the operation.”
Whether or not the higher death rate turns out to be attributable to transurethral resections, health care policy experts said this week that the study illustrates the need for a method within American medicine to systematically review the outcomes of new procedures.
“Transurethral resection became the standard of care before it was carefully evaluated,” Malenka said. “What this points out is the real need when new technology comes along to look at the outcome of care and compare it to current practice.”
“The kinds of questions it raises, you’d think they would have been answered 10 or 15 years ago,” said Dr. Sheldon Greenfield, a professor of medicine at New England Medical Center in Boston, who wrote an editorial accompanying the study in the journal.
“This kind of thing should have been done long ago,” he said.
