Many men with an inguinal hernia (the most common type of hernia, occurring near the groin) are asymptomatic or minimally symptomatic, according to background information in the article. These men and their physicians sometimes delay hernia repair until emergence of pain or discomfort. Surgical repair, while generally safe and effective, carries long-term risks of hernia recurrence, pain, and discomfort. The natural history of an untreated inguinal hernia is not known. Whether delaying surgery and "watchful waiting" is a good option has not been critically tested.
Robert J. Fitzgibbons, Jr., M.D., of Creighton University, Omaha, Neb., and colleagues compared pain, physical function, and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernias who were randomly assigned to a strategy of watchful waiting or surgical repair. The randomized trial, conducted January 1, 1999, through December 31, 2004, included 720 men (364 watchful waiting, 356 surgical repair) who were followed up for 2 to 4.5 years. Watchful-waiting patients were followed up at 6 months and annually and watched for hernia symptoms; surgical repair patients received standard open tension-free hernia repair and were followed up at 3 and 6 months and annually.
At 2 years, intention-to-treat analyses showed that pain interfering with activities developed in similar proportions in both groups (5.1 percent for watchful waiting vs. 2.2 percent for surgical repair; difference 2.86 percent). Average 2-year measurements of pain and discomfort as determined with the physical component score (PCS) were not significantly different from baseline: watchful-waiting patients improved by 0.29 points (of 100) and surgical repair patients improved by 0.13 points (difference, 0.16). Twenty-three percent of patients assigned to watchful waiting crossed over to receive surgical repair (increase in hernia-related pain was the most common reason offered); 17 percent assigned to receive repair crossed over to watchful waiting. Self-reported pain in watchful-waiting patients crossing over to operation improved after repair. Occurrence of post-operative hernia-related complications was similar in patients who received repair as assigned and in watchful-waiting patients who crossed over. Hernia complications in the watchful waiting patients were uncommon (rate of 1.8 per 1000 patient-years).
"A strategy of watchful waiting is a safe and acceptable option for men with asymptomatic or minimally symptomatic inguinal hernias. Acute hernia incarcerations occur rarely, and patients who develop symptoms have no greater risk of operative complications than those undergoing prophylactic hernia repair," the authors conclude.
(JAMA. 2006;295:285-292. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This study was funded by a grant from the Agency for Healthcare Research and Quality, and the American College of Surgeons provided logistic and budget management support. Dr. Fitzgibbons has been retained as an expert witness by Davol, manufacturer of mesh plug used in plug and patch surgical repair of hernia and is a consultant for TyRx Pharma Inc., developers of an antibiotic- and local anesthetic-impregnated mesh for tension-free repair of hernia. No other authors reported disclosures.
Editorial: The Asymptomatic Hernia - 'If It's Not Broken, Don't Fix It'
In an accompanying editorial, David R. Flum, M.D., M.P.H., of the University of Washington, Seattle, and Contributing Editor, JAMA, comments on the study by Fitzgibbons et al.
"Since much of the dynamic involved in counseling patients with asymptomatic hernias relates to the risk of hernia incarceration and bowel compromise, these findings should affect millions of patients with this condition. The other issue that drives decision making for patients is the likelihood that symptoms will develop over time and that once the hernia enlarges or becomes symptomatic, treatment may be more problematic in terms of both timing and outcomes. Here the study by Fitzgibbon et al is also informative in finding no differences in objective outcomes such as infection, length of surgery, or recurrence in those patients assigned to watchful waiting who ultimately did have surgery. This study reinforces the notion that watchful waiting is a safe and acceptable approach in men and can avoid the occasional but important adverse outcomes associated with surgical repair. In fact, the risk of postsurgical complication in patients undergoing surgical repair was much higher than the risks of a hernia-related complication in patients who were watched."
"For years, surgeons have been struggling to find the best way to avoid the greatest harm in patients with incidentally identified hernias. Now, physicians can counsel these patients with regard to both operative and nonoperative strategies, with a better sense of which will do the least harm. If the results of this study are reproduced in other populations and for other types of hernia, then the era of preventive hernia repair should go the way of prophylactic tonsillectomy, cholecystectomy, and appendectomy. Avoiding harm in this case is easy--it can best be accomplished by counseling and educating patients and only repairing hernias that cause symptoms," Dr. Flum writes.
(JAMA. 2006;295:328-329. Available pre-embargo to the media at www.jamamedia.org)