INDIANAPOLIS – The luster has suddenly worn off the time-honored strategy of nonoperative watchful waiting in men with minimally symptomatic inguinal hernias.
New evidence indicates the vast majority of men with asymptomatic or minimally symptomatic inguinal hernias will eventually come to surgery. This may not occur until years down the road, when their advanced age may render surgery more arduous.
Dr. Robert J. Fitzgibbons
"Although watchful waiting remains a safe strategy, even on long-term follow-up, patients who present to their physician to have their hernia evaluated, especially if elderly, should be informed that almost certainly they will come to surgery eventually ... The logical assumption is that watchful waiting is not an effective strategy, as with time almost all men cross over," Dr. Robert J. Fitzgibbons Jr. explained at the annual meeting of the American Surgical Association.
He presented an extended follow-up of patients enrolled in a landmark randomized multicenter clinical trial, one of only two randomized studies ever done comparing watchful waiting versus routine surgical repair for men with minimally symptomatic inguinal hernia. In the earlier report by Dr. Fitzgibbons and coworkers, watchful waiting was deemed "an acceptable option" because only 23% of patients crossed over to surgery due to increased pain during the first 2 years of follow-up (JAMA 2006;295:285-92).
At the ASA meeting, however, he presented updated 10-year follow-up data on 167 patients from the cohort initially assigned to watchful waiting. The rate of crossover to surgery was 68% by 10 years, with a marked age-based divergence. Patients below age 65 had a 62% crossover rate, while those above that age had a 79% crossover rate, according to Dr. Fitzgibbons, professor of surgery and chief of the division of general surgery at Creighton University, Omaha, Neb.
The good news was that hernia incarceration was a rare event, occurring at a rate of just 0.2% per year over the course of 10 years.
"We as surgeons have been taught for many years that we must repair all our hernias to prevent hernia accidents. Well, only three patients in our whole study developed incarceration, for which they underwent surgery with no mortality," Dr. Fitzgibbons noted. "The risk of a hernia accident should not be considered an indication for surgery. Older studies in the literature which would suggest otherwise can no longer be considered relevant."
He offered a caveat regarding the study findings: Participants were enrolled after they sought medical attention because of their hernias, even though they were asymptomatic or only minimally symptomatic. So the study results are most applicable to men concerned enough about their hernias that they visit a physician for that reason.
"It’s probably not valid to extrapolate the conclusions in this study to the entire population of minimally symptomatic inguinal hernia patients," the surgeon said. "Physicians have been observing elderly patients for years and would be loath to believe a crossover rate this high."
Nevertheless, the results of this study are virtually identical to those of the only other randomized trial of watchful waiting, which was conducted by surgeons at the University of Glasgow. The most recent update from that study showed an estimated crossover rate in the watchful waiting group of 16% at 1 year, 54% at 5 years, and 72% at 7.5 years. As in the American study, the rate of acute incarceration was reassuringly small. The investigators concluded that watchful waiting appears pointless, and they recommended surgical repair for medically fit patients (Br. J. Surg. 2011;98:596-9).
Discussant Dr. Michael E. Zenilman commented that his own approach is to individualize patient management based in large part upon activity level.
"When I see patients who are 80 years old in the office with an asymptomatic hernia, my conversation with them is about what their lifestyle is like. If they’re an active golfer I know that they’re going to end up getting their hernia fixed. If they’re sedentary, sitting at home in retirement, they don’t. So I think the next step in your research project should be to find out what the activity level is of these patients who are getting older and have asymptomatic hernias," said Dr. Zenilman, vice chair and regional director of surgery for the Washington, D.C., region, Johns Hopkins Medicine.
Dr. Fitzgibbons’ trial was funded by the Agency for Healthcare Research and Quality with support from the American College of Surgeons. He reported having no financial conflicts.