Canadian Association of General Surgeons and American College of Surgeons evidence-based reviews in surgery. 26. Watchful waiting versus repair of inguinal hernia in minimally symptomatic men.

Objective: To compare pain and physical function in men with minimally symptomatic inguinal hernia with watchful waiting or surgical repair. Design: Randomized controlled trial. Setting: Five community and academic centres in Canada and the United States. Patients: A total of 724 men were randomly assigned to a watchful waiting group (n = 366) versus a standard Lichtenstein open tension-free repair group (n = 358). Random assignment of patients was stratified by the presence of primary or recurrent hernia, unilateral or bilateral hernia and study site. Intervention: Patients in the watchful waiting group received instructions to watch for hernia symptoms and to contact their physicians if problems developed. Follow-up for these patients occurred at 6 months and annually. Patients who received the standard open tension-free repair were followed up at 3 months, 6 months and annually. Main outcome measure: Primary outcomes were pain and discomfort that interfered with usual activities 2 years after enrollment and changes from baseline to 2 years in the physical component score (PCS) of the SF-36 Health Survey, version 2. Secondary outcomes included complications, patient-reported pain, functional status, activity levels and satisfaction with care. Results: Primary intention-to-treat outcomes were similar at 2 years for patients in the watchful waiting and surgical repair groups (pain-limiting activities 5.1% in the watchful waiting group v. 2.2% in the surgical repair group, p = 0.52; PCS improvement over baseline 0.29 points in the watchful waiting group v. 0.13 points in the surgical repair group, p = 0.79). Twenty-three percent of patients assigned to the watchful waiting group crossed over to receive surgical repair (increased pain was the most common reason); 17% of patients assigned to the surgical repair group crossed over to watchful waiting. The occurrence of postoperative hernia-related complications was similar among patients who received surgical repair as assigned and among patients in the watchful waiting group who crossed over to the surgical repair group. One watchful waiting patient (0.3%) experienced acute hernia incarceration without strangulation within 2 years. A second had acute incarceration with bowel obstruction at 4 years. The authors observed a frequency of 1.8 events per 1000 patient-years, including patients followed for up to 4.5 years. Conclusion: Watchful waiting is a safe and acceptable option for men with asymptomatic or minimally symptomatic inguinal hernias. Delaying surgery until symptoms increase is safe because acute hernia incarcerations occur rarely.