CHICAGO, Jan. 17 - Middle-age men with inguinal hernias who have minimal symptoms can safely put off surgical repair until symptoms increase, according to results of a 720-man randomized trial here.
Watchful waiting in this cohort does not significantly increase pain-limiting activities (P=0.52) nor does it significantly reduce physical function (P=0.79), reported Olga Jonasson M.D., of the University of Illinois and colleagues in the Jan. 18 issue of the Journal of the American Medical Association.
Action Points
- Explain to interested patients that this study suggested that a strategy of watchful waiting is safe for middle-age men with minimal symptoms from inguinal hernia.
- Explain that surgery can be delayed until pain increases.
William Richardson, MD, director of minimally invasive surgery at the Ochsner Clinic in New Orleans, said the study results will be useful in counseling hernia patients about the timing of repair surgery. "One thing that we can tell patients now is that the risk of strangulation is extremely low -- the overall risk in this study was just 0.3% over a two-year period. We always knew the risk was low, but this gives us evidence to back-up that statement."
Dr. Richardson, who was not involved in the study, said the study does not provide clinical guidance for treatment of inguinal hernia in young men. The average age in this study is 57, he noted.
However, he said that for patients with minimal symptoms and easily reducible hernias, this study provides reassurance for patients who opt to put off repair surgery.
The study randomized 356 men to surgical repair and 364 to watchful waiting. Just over half of the men were aged 45 to 65, about a third were over 65 and almost 12% were younger than 40.
Of note, 23% of the watchful waiting patients crossed over to surgical repair, citing an increase in hernia-related pain, and 17% of the surgery patients crossed over to watchful waiting.
Dr. Jonasson compensated for the high cross over rate with an intention-to-treat analysis.
In an accompanying editorial, David R. Flum, M.D., M.P.H of the University of Washington in Seattle, pointed out that even with an intention-to-treat analysis it "may seem difficult to make sense of a trail that purports to evaluate the outcomes of two approaches when nearly 40% of patients did not receive the treatment to which they were assigned."
That said, Dr. Flum concluded that the study by Dr. Jonasson and colleagues will provide surgeons with necessary information so that they can "counsel these patients with regard to both operative and nonoperative strategies, with a better sense of which will do the least harm."
Both groups reported less pain at two years, and the "perception of pain unpleasantness" was significantly less in the surgical group than the watchful waiting group (P=0.01).
In addition, short-term complications were reported by 32.7% of patients in the surgical repair group, but chronic pain sufficient to limit activities was reported by just 1.7% of the surgery patients and recurrence of hernia -- a known risk associated with surgery -- occurred in just 1.4% of patients.
The authors concluded that in general watchful waiting is a safe and acceptable option and "patients who develop symptoms have no greater risk of operative complications than those undergoing prophylactic hernia repair."
Dr. Flum pointed out in his editorial, however, that "it remains to be seen if these results apply to all populations with inguinal hernias. For instance, younger patients, women, and those with other types of hernia may have different risks of hernia complications, as well as perspectives on these strategies that might result in a different outcome."
He added, "The environment a patient lives in or travels to frequently should also be considered in decision making regarding future risk. For example, access to appropriate levels of health care is a key component of a watchful-waiting strategy so that if the hernia becomes incarcerated, prompt treatment is available."
Primary Source
Journal of the American Medical Association
Source Reference: Fitzgibbons RJ et al "Watchful Waiting vs. Repair of Inguinal Hernia in Minimally Symptomatic Men A Randomized Clinical Trial" JAMA 2006;295:285-292
Secondary Source
Journal of the American Medical Association
Source Reference: Flum DR "The Asymptomatic Hernia 'It It's Not Broken, Don't Fix It" JAMA 2006; 295: 328-329