An Expertise-based Randomized Controlled Trial Comparing Midline Excision Versus Karydakis Operation at Surgery for Pilonidal Sinus
Excision in the midline and primary suture is a long proven method of treating pilonidal
sinus. However it's associated with high incidence of post operative infection and
recurrence. On the other hand Karydakis operation (excision lateral of the midline,
transposition flap and primary suture) is just a slightly more complicated procedure but has
five times less recurrences reported in case series. The purpose of the present study is to
compare the surgical results and costs of the two surgical methods utilized. In addition the
investigators aim to compare the quality of life at defined time points after surgery.
Eligible patients are randomized to two groups of surgeons, well trained in either the
midline operation or the Karydakis operation (expertise based design). The design of the
study allows wide inclusion criteria for participants, a cost-utility approach in the
analysis, and a high external validity of the conclusions reached.
Comparison: Midline excision andd primary suture compared with the Karydakis operation
(excision lateral of the midline and primary suture) for pilonidal disease.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
time to complete wound healing
one year or until reoperation
Christoffer Odensten, MD
County Council of Norrbotten, Sweden
Sweden: The National Board of Health and Welfare