Page 105 - International guidelines for groin hernia management

Hernia

It has also been shown that, due to mesh technology improvements at individual facilities. 145, 146 Registries can
improvements and a better understanding of the extent of serve as the basis for observational studies, may detect and
inguinal floor dissection needed in hernias with defects of lead to the analysis of rare events, may provide data needed
less than 3 cm, expensive fixation devices are for RCTs, and facilitate questionnaire studies. Addition-
unnecessary. 141, 142 ally, patients may be recruited from registers for clinical
trials that address specific questions outside a registry’s
scope.
Registry data reflects effectiveness in routine care and
Chapter 25 possesses high external validity, provided their coverage is
broadly inclusive of a national population. In contrast, RCTs
and other trials are investigational and often report on effi-
Groin Hernia Registries cacy obtained in expert hands when interventions are opti-
mally applied to carefully selected subjects (Fig. 8). 147 RCTs
P. Nordin, A. Montgomery, L. N. Jorgensen, U. Klinge and (Table 5) are widely recognized as the criterion standard in
T. Bisgaard the evaluation of pharmacological interventions, but prob-
lems may arise if surgical techniques are compared. 144
Introduction The optimal design for comparing surgical methods is a
Well-designed RCTs advance the scientific basis of our randomized study involving surgeons of equal skill levels
knowledge and promote evidence-based medicine because who demonstrate equal levels of objectivity with the
of their powerful internal validity. 143, 144 However, some methods being compared. However, even in study settings,
aspects of medical care cannot be easily addressed by patient-related and surgeon-related factors, which cannot
RCTs. Studies from well-validated registries can provide be controlled, influence outcomes. Technical skill variation
important information as well. Registry studies of large will always exist and was demonstrated in an RCT mea-
populations have the unique strength of reflecting clinical suring surgical skill. 148 In this study, low surgical perfor-
reality (e.g., outcomes in routine clinical practice) and thus mance scores were highly correlated with 5-year hernia
provide the surgical community a high level of external recurrence rates. The question naturally arises then, how to
validity. consider this issue when analyzing studies? Similarly,
KQ25.a When compared with RCTs, do well-validated IH should RCTs be the only means we use to evaluate surgical
quality registries, and the studies done on their databases, methods?
offer additional valuable evidence-based information to Hernia surgery is usually considered within the purview
hernia surgeons? of general surgery and is often performed by non-special-

Evidence in literature ized surgeons or trainees. 149 Factors like patient age, gen-
Hernia registries provide long-term monitoring of surgical der, comorbidities, hernia-specific conditions and surgeons’
quality in unselected patients and facilitate surgical care preferences and experience might influence surgical indi-
150–152
cations and the choice of operative technique.

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