Clinical Question: Is watchful waiting (i.e., deferring surgical repair) safe in asymptomatic or minimally symptomatic men with inguinal hernias?
Setting: Outpatient (any)
Study Design: Randomized controlled trial (single-blinded)
Synopsis: Although many men with inguinal hernia are asymptomatic or minimally symptomatic, surgical repair usually is recommended to prevent complications such as acute bowel incarceration. The investigators enrolled 720 men 18 years or older who had asymptomatic or minimally symptomatic inguinal hernias. Participants were randomized (concealed allocation assignment) to watchful waiting or to standard inguinal hernia repair. Complete follow-up occurred for 2.0 to 4.5 years for 90 percent of enrollees. Patients aware of treatment group assignment self-reported outcomes.
Primary outcomes included pain and discomfort interfering with usual activities and overall quality of life. Secondary outcomes included complications. Twenty-three percent of patients assigned to watchful waiting crossed over to receive surgical repair, and 17 percent of participants assigned to surgical repair crossed over to the watchful waiting group.
Using intention-to-treat analysis, there were no significant differences reported between the two groups in pain-limiting activities or overall quality of life. Postoperative complications occurred similarly in patients initially assigned to surgical repair and in those who crossed over from watchful waiting. One watchful waiting patient experienced acute hernia incarceration without strangulation within two years, and one patient had acute incarceration with bowel obstruction at four years, with an overall complication rate for the watchful waiting group of 1.8 per 1,000 patient-years. The sample size of 720 patients had a 90 percent power to detect a 10 percent difference for each of the primary outcomes.
Bottom Line: Watchful waiting is a safe and acceptable option for men with asymptomatic or minimally symptomatic inguinal hernias. Acute complications rarely occur, and patients who delay surgery are not at an increased risk of operative or postoperative complications. (Level of Evidence: 1b)