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Page 4 of 6 McBee et al. Mini-invasive Surg 2021;5:18 https://dx.doi.org/10.20517/2574-1225.2021.08

imaginable health state). The patient pain/discomfort score was found to be 0.35 [95% confidence interval
(CI): 0.28-0.41)] in the elective repair group and 0.58 (95%CI: 0.52-0.64) in the WW group. The difference
of these means (MD) was - 0.23 (95%CI: 0.32-0.14), showing that a relevant difference in favor of elective
repair could not be ruled out. Ninety-nine patients (37.8%) crossed over from the WW cohort to surgical
repair, mostly due to worsening pain. Six patients (2.3%) underwent emergent surgery for strangulation or
incarceration but none suffered adverse sequelae such as the need for bowel resection after three years of
follow-up. The 3-year event-free survival was 80.9% in the surgical repair group and 77.2% in the WW
group. The cumulative incidence of patients with at least one or more events (recurrence, moderate to
severe pain, ischemic orchitis, hernia complications, etc.) in the surgery repair and WW groups was 17.5%
and 20.6%, respectively at three years. Although a statistically significant advantage for WW over routine
repair was not demonstrated, the authors concluded that when looking at the primary and secondary
endpoints as a whole, watchful waiting was a reasonable alternative compared with routine elective surgery
in male patients. Due to the recency of the trial’s completion, long-term analysis is not yet available.

SIMILARITIES BETWEEN TRIALS
Generally, all three trials reached the same conclusion: WW is a safe and appropriate strategy for initial
management of inguinal hernia in male patients who present with minimal or no symptoms. The previous
belief held by many surgeons that a significant proportion of patients not treated by surgical repair upon
presentation would suffer a hernia accident which would result in a significant increase in morbidity and
mortality was not supported. Few patients in the WW cohorts exhibited serious hernia accidents in short-
and long-term follow-up. Table 1 describes notable findings across all three clinical trials. The trials
concluded that potential future risk of a hernia accident should not contribute to an indication for surgical
repair. Instead, relief of symptoms such as pain and other issues related to improvement of quality of life
should be used as the metric to pursue surgical intervention. In the two studies with long-term results, the
rate of crossover from WW to surgical repair was high (approximately 70%) due mostly to development of
worsening pain.

Gong and colleagues recently performed a meta-analysis which included the short- and long-term follow-
up data from the North American, UK, and Netherlands trials . Patients who underwent surgical repair
[14]
reported significantly less pain with movement at a minimum of 12-month follow-up. However, there was
no significant difference in the physical component score, mortality, surgical complications, or post-
operative hernia recurrence between the WW and surgical repair groups. The meta-analysis confirmed that
most patients will undergo an elective hernia repair operation within 10 years of presentation. Regardless,
due to the low incidence of hernia accidents, the meta-analysis concluded that WW is a safe and acceptable
option in short-term management of inguinal hernias in men. The authors also noted that WW provides a
delay in surgery if desired but does not prevent relatively inevitable repair. Similar conclusions were reached
[15]
by Reistrup and colleagues who recently published a systematic review of randomized and
nonrandomized RCTs investigating watchful waiting.

TRIAL LIMITATIONS
Similar limitations were exhibited by all three clinical trials: generalizability, sample size, and length of
follow-up. Most trial participants were white males, limiting extrapolation to patients of differing races and
sexes. The authors of all trials reported that recruiting patients was difficult with only 45% and 69% of
eligible patients agreeing to randomization in the North American and UK trials, respectively.

Additionally, it is important to note that clinical trials in low- and middle income countries are currently
lacking. All trials completed to date are from high income countries, despite evidence that most hernias