Randomised Trials in Surgery: The Burden of Evidence
2012
A randomised controlled trial (RCT) is considered the hierarchical peak of evidence-based medicine and a general
demand for any result to be evaluated by RCTs has evolved. Yet, many advances in operative surgery do not result
from RCTs and many controversies remain without an RCT being conducted. A randomised comparison of laparoscopic
versus open liver resection has recently been called for. Using such a trial and others as examples, we examine the limitations
of randomised design in skill-dependant interventions. Surgical procedures are skill-dependant, constantly developing,
irreversible and traumatising. Additionally, placebo control is usually unethical and adequate blinding difficult or impossible
to accomplish. Under these circumstances, surgeon and patient participation will be problematic and the resulting
data will tend to have low external validity. While some of these obstacles can be modified, others will remain. Nonrandomised,
prospective cohort comparison has other weaknesses, but may add complementary data with good external
validity. An alternative hierarchy of evidence is warranted in this field.
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