In the study, published in the Jan. 18 issue of JAMA, a journal of the American Medical Association, 720 men with inguinal hernia (a small part of the large or small intestine protruding into the groin) were randomly assigned to either "watchful waiting" or standard hernia repair surgery and followed up for two to 4.5 years.
In an earlier study, the researchers had compared non-invasive laparoscopic hernia operations with open procedures. "But there are a lot of men walking around with hernias who say, 'If it's not bothering me, I won't bother it,'" said Dr. Olga Jonasson, professor of surgery at the University of Illinois at Chicago, who initiated the study. "We wanted to know if it was safe to delay surgery altogether."
Of the 364 men assigned to watchful waiting, 23 percent later chose to have surgery, usually because of increased pain. Seventeen percent of the 356 men assigned to surgery chose instead to cross over into watchful waiting. Waiting did not increase the rate of complications from surgery in those patients who eventually had it, and the rate of complications from hernias left unrepaired was even lower.
After two years, the same proportion of men in each group reported developing pain great enough to interfere with everyday activities, but both groups overall reported less pain at the end of the two years. Patients who received surgical repair reported significantly greater improvement in their ability to perform a range of everyday activities.
The authors conclude that a strategy of watchful waiting is "a safe and acceptable option" for men whose hernias are not causing discomfort that interferes with their day-to-day activities. Hernia complications occur only rarely, and patients who develop symptoms have no greater risk of operative complications than those undergoing preventative hernia repair.
Because the risk of complication increases with the length of time a hernia is present and is more common in the elderly, the researchers established a voluntary long-term registry for the clinical trial participants to access the occurrence of hernia complications and recurrences annually.
Other authors on the study include Dr. Robert Fitzgibbons Jr. of Creighton University; Dr. Jon Thompson of the Omaha VA Medical Center; Anita Giobbie-Hurder, Domenic J. Reda and Jia Wang of the VA Cooperative Studies Program in Hines, Ill.; James Gibbs, Dorothy Dunlop and Martin McCarthy Jr. of Northwestern University; Dr. Leigh Neumayer of the University of Utah; Dr. Jeffrey Barkun of McGill University; Dr. James Hoehn of Marshfield University; Drs. Joseph Murphy and George Sarosi Jr. of the Dallas VA Medical Center; and Dr. William Syme of the University of Nebraska, Omaha.
The study was funded by the Agency for Healthcare Research and Quality. The American College of Surgeons provided logistic and budget management support.
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