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McBee et al. Mini-invasive Surg 2021;5:18 https://dx.doi.org/10.20517/2574-1225.2021.08 Page 3 of 6

NORTH AMERICAN TRIAL
A randomized control trial with 720 men, 18 years of age or older with inguinal hernias who presented
asymptomatically or with minimal symptoms was completed in North America in 2006, showing WW as a
safe alternative to surgical repair . Patients were assigned to either a WW or a Lichtenstein repair approach
[6]
and followed to observe differences in development of a hernia accident between the two groups. Patients
were similar at baseline in terms of age, American Society of Anesthesiology classification, preexisting
conditions, hernia type, and hernia characteristics. At 2 years of follow-up, only 1 patient (0.3%) required
emergent surgery for an acute hernia incarceration and the patient was not found to have strangulation.
There was no difference in quality of life between the two groups at 2 years. Patients in the WW group
crossed over to the surgical repair group at a rate of 23%, most commonly due to pain, and were more likely
to do so if they had reported higher levels of pain at the start of the trial. At 4.5 years of follow-up, only one
additional patient in the WW group developed acute incarceration with bowel obstruction, for a total
surgical emergency rate of 1.8 per 1000 person-years at the end of the trial. Although this study clearly
showed that WW was a safe alternative to routine repair for minimally symptomatic males, subsequent
long-term follow-up at 10 years showed that 68% of patients originally in the WW group had crossed over
to surgical repair, mostly due to increased pain . The authors recommended that men with minimally
[11]
symptomatic inguinal hernias be informed that WW is a safe preliminary management choice to avoid
immediate operative intervention but most individuals will eventually undergo surgical repair if they live
long enough.

UNITED KINGDOM TRIAL
In this trial, 160 men aged 55 years or older with minimally symptomatic inguinal hernias were enrolled in a
single-center randomized controlled trial to investigate WW vs. surgical repair . At one year of follow-up,
[7]
there were no significant differences in pain scores between the watchful waiting and surgical repair
cohorts, although the surgical repair group did report improvement in their perceived quality of life. The
crossover rate from WW to surgery was 29% at one year, with increasing pain and enlargement of the
hernia responsible for most cases of crossover. The incidence of serious events in the WW group was
minimal; one patient developed a hernia incarceration and two others experienced cardiovascular events
after crossover to the repair group. The authors hypothesized that the cardiovascular complications could
have been prevented had the patients undergone surgical repair at the start of the trial, but this has been
criticized by other authorities as highly speculative . Similar to the North American Trial, long-term
[12]
follow-up disclosed a high crossover rate to surgery (72% at 7.5 years by Kaplan-Meier analysis),
demonstrating that for most patients who present with an inguinal hernia, surgical repair will eventually
become necessary .
[13]

NETHERLANDS TRIAL
In 2018, researchers in the Netherlands reported results from a multicenter randomized controlled trial to
determine the noninferiority of WW compared to elective hernia repair in 496 men aged 50 years or older
who presented with mildly symptomatic or asymptomatic inguinal hernias . The primary outcome
[8]
measure was pain and discomfort at 2 years of follow-up using a 4-point pain/discomfort score which
ranged from no pain or discomfort to severe pain or discomfort due to the hernia while working, exercising
or performing any of a patient’s usual activities. Secondary endpoints included: health-related quality of life
as measured by the Short-Form 36 (SF-36) questionnaire, overall 3-year crossover rate in patients assigned
to watchful waiting, 3-year event-free survival between the 2 treatment groups, hernia complication
(incarceration or strangulation), ischemic orchitis, and recurrent hernia. The EuroQol-5D (EQ-5D)
questionnaire was also assessed at baseline, 3, 12, 24, and 36 months. The EQ-5D included a visual analog
scale (VAS) to rate overall health status on a scale of 0 (worst imaginable health state) to 100 (best