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Objective: To establish a literature-based surgical ap- of patients with asymptomatic IH managed by surgery
proach to asymptomatic inguinal hernia (IH). or watchful waiting were determined.
Data Sources: PubMed, the Cochrane Library data- Data Synthesis: No significant difference in pain scores
base, Embase, national guidelines (including the Na- and general health status were found when comparing the
tional Library of Guidelines Specialist Library), Na- patients who were followed up with the patients who had
tional Institute for Health and Clinical Excellence surgery. A significant crossover ratio ranging between 23%
guidelines, and the National Research Register were and 72% from watchful waiting to surgery was found. In
searched for prospective randomized trials comparing sur- patients with watchful waiting, the rates of IH strangula-
gical treatment of patients with asymptomatic IH with tion were 0.27% after 2 years of follow-up and 0.55% af-
conservative treatment. ter 4 years of follow-up. In patients who underwent elec-
tive surgery, the range of operative complications was 0%
Study Selection: The literature search retrieved 216 ar-
to 22.3% and the recurrence rate was 2.1%.
ticle headlines, and these articles were analyzed. Of those
studies, a total of 41 articles were found to be relevant and
Conclusion: Both treatment options for asymptomatic
2 large well-conducted randomized controlled studies that
published their results in several articles were reviewed. IH are safe, but most patients will develop symptoms
(mainly pain) over time and will require operation.
Data Extraction: The pain and discomfort, general
health status, complications, and life-threatening events Arch Surg. 2012;147(3):277-281
I
NGUINAL HERNIA (IH) OCCURS among different populations.3,4 For ex-
when a peritoneal sac protrudes ample, IHR is done in 10 per 10 000 people
through a weak point within the in the United Kingdom, while the rate is
groin area. It often contains ab- 28 per 10 000 people in the United States.5
dominal content and is tradition- There are several possible explanations for
ally treated with surgery.1 As a rule, IH is this observable fact, including different pri-
diagnosed by a simple physical examina- mary care management, costs, and insur-
tion except in cases where the diagnosis ance policies.
is obscure; in these cases, different mo- As in any other operation, elective IHR
dalities are used for confirmation.2 Asymp- carries its share of complications. Surgi-
tomatic IH is a term used to describe the cal site infection, hematoma, urinary re-
condition in a patient who has a groin tention, and other short-term morbidi-
bulge or impulse cough with only minor ties are well known, as are long-term
or no symptoms. On the other hand, an complications including chronic groin
incidental operative finding of an inter- pain, neuralgia, and IH recurrence.6 How-
nal ring defect with no groin lump or other ever, postponing the operation might carry
Author Affiliations: symptoms is defined as an occult IH, a con- a risk of acute IH and visceral organ stran-
Department of General Surgery dition prevalent since the introduction of gulation with additional risks of gan-
A, Haemek Medical Center,
laparoscopic surgery. grene, perforation, and infection of the
Afula, Israel (Dr Mizrahi); and
Department of Colorectal Inguinal hernia repair (IHR) is the most peritoneal cavity. Hence, operations in the
Surgery, Darent Valley Hospital frequent elective operation performed in emergency setting for incarcerated IH have
(Drs Mizrahi and Parker) and the United States and Europe, although higher morbidity and mortality rates.7
Fawkham Manor Hospital when comparing the rate of surgery per- The aim of this review is to establish a
(Dr Parker), Kent, England. formed to treat IH there is great variety surgical approach to asymptomatic IH by
2 Excluded after full-text assessment The randomized controlled studies included in this re-
1 Cost-effectiveness study
1 Family assessment of hernia burden
view followed male patients only. An important differ-
ence between the studies is the difference with ages. The
5 Articles included in the review
O’Dwyer group10,12 included patients aged 55 years and
older with an average of 3.2 years from diagnosis. The
Fitzgibbons group9,11,13,14 included younger patients (aged
Figure. Study selection. ⱖ18 years), of whom 15% were diagnosed as having had
an IH for less than 6 weeks (Table).
means of surgery or watchful waiting in terms of pain
and discomfort, general health status, complications,
COMMENT
and life-threatening events based on prospective ran-
domized controlled studies in the literature.
Inguinal hernia is a common condition, with a rate vary-
ing between 0.6% and 25.2% among males within dif-
METHODS
ferent age groups and populations.17 Abramson et al17 used
the Bailey examination technique to diagnose IH while
INCLUSION AND EXCLUSION OF ARTICLES surveying the male population of West Jerusalem be-
Prospective randomized trials comparing surgical treatment and
tween 1969 and 1971. They subdivided patients who had
conservative treatment of patients with asymptomatic IH were obvious IH and those with a more subtle defect. They
eligible for this review. The methods, inclusion and exclusion found that the obvious IH rate among men aged 25 to
criteria, follow-up period, early and late complications, IH re- 34 years was 1% and that the rate of cough impulse felt
currence, and mortality rate were examined in each article. Ar- when performing physical examination (digitation of the
ticles that offered data concerning patients with symptomatic inguinal canal) was 11%. In that study, the rate of obvi-
IH, presented retrospective data or case series data, or dealt with ous IH rose with age, while the rate of cough impulse on
the cost-effectiveness of the treatment of IH were excluded. palpation only decreased; when surveying the popula-
tion older than 75 years, the study found obvious IH in
IDENTIFICATION OF TRIALS 29.8% and cough impulse on palpation in 4.3%. This study
not only implies a relationship between prevalence of
An electronic search was performed from 1966 to April 2011 symptomatic IH and age but also suggests that IH pro-
using PubMed, the Cochrane Library database, Embase, na-
gresses with time.17
tional guidelines (including the National Library of Guide-
lines Specialist Library), National Institute for Health and Clini- The natural history of IH progression is vague in the
cal Excellence guidelines, and the National Research Register. literature, mostly owing to the traditional approach of
The search included the following terms: hernia, inguinal, groin, operating on almost any patient with the diagnosis. Only
asymptomatic, incidental, occult, and natural history, with the 2 prospective randomized controlled trials analyzed the
use of Boolean operators and/or with an age limit of older than options of watchful waiting vs operation. Fitzgibbons et
19 years (adults only). All trials and report headlines irrespec- al9,11,13,14 had conducted a multicenter study sponsored
tive of language or publication status were read by 2 indepen- by the American College of Surgeons, and O’Dwyer et
dent readers (H.M. and M.C.P.) and sorted by their relevance. al10,12 published a single-team, single-hospital study. Both
The reference lists of obtained articles were also searched to trials compared groups of patients having open IHR with
identify additional relevant citations, and further abstract read-
those having follow-up only.
ing of those publications was performed.
The outlines for the studies by Fitzgibbons et al and
O’Dwyer et al are important as they are the main source
RESULTS of evidence-based information for this discussion. Fitz-
gibbons et al conducted a multicenter study suggesting
ELIGIBLE TRIALS that observation is an acceptable alternative to open-
approach tension-free repair for patients with minimal
The literature search retrieved 216 article headlines, and or no IH symptoms.9 The patients were followed up
these articles were analyzed. Of those studies, a total of for a minimum of 2 years with an expected primary
Intervention
or Grouping
Study Group Source Description Participants (Patients, No.) Outcomes
Fitzgibbons Fitzgibbons et Study protocol NA NA NA
group al,11 2003 description
Fitzgibbons et RCT of watchful waiting Men aged ⱖ18 y with Observation (364) vs Pain and discomfort
al,9 2006 vs open IH repair asymptomatic or open IH repair (356) interfering with usual
minimally symptomatic activities 2 y after
IH enrollment and
postoperative
complications
Thompson et Description of Patients from the Surgery within 6 mo of Complications, pain,
al,13 2008 outcomes of early Fitzgibbons et al9 study diagnosis (288) and functional status, and
surgery vs delayed who had immediate after 6 mo from patients’ satisfaction after
surgery in patients tension-free IH repair vs diagnosis (65) mean follow-up of 13.4
with asymptomatic delayed IH repair mo (range, 9-33 mo)
IH from surgery
Sarosi et al,14 Identifying preoperative Patients from the Watchful waiting (250) Preoperative factors that
2011 characteristics of Fitzgibbons et al9 study vs crossover from will predict patient
patients who had who crossed over from watchful waiting to crossover to surgery
failed observation of observation to surgery or surgery (72)
asymptomatic IH had developed
considerable pain
O’Dwyer group O’Dwyer et al,10 RCT of observation vs Men aged ⱖ55 y with Observation (80) vs Pain score 1 y after
2006 operation for patients asymptomatic IH open IH repair (80) enrollment
with asymptomatic
IH
Chung et al,12 Long-term outcome of Patients from the O’Dwyer Examine long-term Rate of crossover from
2011 patients with painless et al10 study outcomes of patients observation to surgery
IH with asymptomatic and contralateral or
IH for median recurrent IH development
follow-up of 7.5 y
(160)
Abbreviations: IH, inguinal hernia; NA, not applicable; RCT, randomized controlled trial.
outcome measure of pain or discomfort using a 4-item tients showed that after 5 and 7.5 years, the rates of con-
graded scale and general health status (36-Item Short version to surgery were 54% and 72%, respectively, mainly
Form Health Survey) and a secondary outcome mea- because of pain. No significant difference in pain scores
sure of costs of treatment. Postoperative complications, was found when comparing the patients who had an op-
life-threatening events, and deaths were also re- eration and those who were observed.12 Thus, the op-
corded.9,13 A follow-up study of the group of patients who eration did not add significant chronic pain. The study
had surgery was published recently to identify the char- by Fitzgibbons et al showed that pain interfering with
acteristics of the patients with failure by a management daily activities was the same in both the operation and
of observation.14 O’Dwyer et al conducted a randomized follow-up groups. Patients who crossed over from watch-
prospective clinical trial that examined the 1-year out- ful waiting to surgery had reported an increase in pain
come of operation vs a watchful waiting policy in male after the operation, but by their 2-year follow-up the pain
patients aged 55 years or older who had asymptomatic interfering with activities was not significantly higher than
IH for more than 3 years. They measured pain at rest and that in the group managed conservatively. The question
movement with a visual analog scale at baseline, 6 months, of pain and discomfort caused by IH was the basis of the
and 12 months as well as general health status using a study by Hair et al18 that evaluated 699 patients before
questionnaire (36-Item Short Form Health Survey)10 and IHR. No pain was found in 24% of the cases and 71% did
published the long-term outcomes after an average fol- not report any effect of the IH during leisure activity. Using
low-up time of 7.5 years (range, 6.2-8.2 years).12 Kaplan-Meier regression analysis, Hair et al found that
Although there are several differences between the the cumulative probability of a patient presenting with
studies by Fitzgibbons et al and O’Dwyer et al, both pain increased with time to 90% at 10 years.
showed no difference regarding pain and discomfort be- General health status was measured in both random-
tween the patients who had surgery and those who were ized controlled studies using a questionnaire. In the study
followed up. Some of the participants in the study by by O’Dwyer et al, improvement was noticed in the op-
O’Dwyer et al who were randomized to the operation eration group compared with the watchful waiting group
group had waited for more than 6 months before sur- during follow-up (calculations were identical when per-
gery. Results from analyses on an intention-to-treat ba- formed on an intention-to-treat basis as well as for ac-
sis as well as treatment received were very similar. The tual treatment received). On the other hand, the study
long-term follow-up report for the same group of pa- by Fitzgibbons et al showed similar results of general