Page 13 - International guidelines for groin hernia management

Hernia

Evidence in literature A cost-effectiveness analysis was performed on the
The literature search on this topic yielded six randomized groups, calculating both costs and quality-adjusted life-
controlled trials (RCTs), two systematic reviews and three years (QALYs). 137 At 2 years, those in the surgery group
cohort-controlled studies. Two study groups produced all had a $1831 higher mean cost per patient when compared
six RCTs. 135, 136 with WW group subjects. The cost per additional QALY in
A 2006 trial of 720 men with minimally symptomatic or the surgery group was $59,065. WW was judged to be a
asymptomatic IHs randomized subjects to either primary cost-effective management option for men with minimal or
surgery or watchful waiting (WW). 135 Primary outcomes absent hernia symptoms.
were pain interfering with normal activities and change in These same groups were restudied 7 years later. 2
physical function as measured by the physical component Crossover rates, crossover reasons and time to crossover
score of the SF-36 at 2 years. Secondary outcomes inclu- were investigated. The crossover rate from WW to surgery
ded complications, and patient-reported pain, functional was 50% at 7.3 years from randomization. Median cross-
status, activity levels and satisfaction. Pain interfering with over time was 3.7 years in men over 65 and 8.3 years in
daily activity occurred in 5.1% of the WW group and 2.2% those 65 and younger (p = 0.001). The estimated crossover
in the primary surgery group at 2 years (p = 0.52). SF-36 rate at 10 years was 68% using Kaplan–Meier analysis.
improvement from baseline was seen in both groups. One The primary reason for crossover was pain. When patients
hernia incarceration occurred within the 2-year minimum over 65 at time of original study enrollment were analyzed,
follow-up period and another occurred after 4.5 years the estimated 10-year crossover rate was 79.4%. This
(relative risk of 1.8 per 1000 patient years). The crossover compares with a 62% 10-year crossover estimate for those
rates were high for both groups. At 2 years, 17% crossed 65 or younger at enrollment. In the 10-year follow-up only
over from surgery to WW and 23% from WW to surgery. three men (2.4%) underwent surgery for a hernia accident.
A WW strategy was deemed safe and acceptable since There was no mortality. The incidence of a hernia accident
acute incarcerations rarely occurred. A secondary analysis for the entire cohort was 0.2 per 100 person-years. These
found that those who developed symptoms had no greater studies support the idea that men with IHs and minimal or
risk of operative complications or recurrence than those absent symptoms should be counseled that although WW is
undergoing elective hernia repairs.

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