The trial compares excision in the midline at surgery for pilonidal disease versus excision lateral of the midline (Karydakis operation) at surgery for pilonidal disease by randomly allocating patients with pilonidal disease to two groups of surgeons, each group being trained for one of the two methods.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
A midline excision is made for the treatment of pilonidal sinus disease.
A Karydakis operation is done for the treatment of pilonidal sinus disease.
Sunderby Regional Hospital
Luleå, Sweden
Umeå University Hospital
Umeå, Sweden
time to complete wound healing
Time frame: one year or until reoperation
health-related quality of life
Time frame: one year
time needed returning to normal physical activity after operation
Time frame: one year or until reoperation
days spent on sick-leave
Time frame: one year or until reoperation
health care costs and total costs
Time frame: one year
postoperative wound infection rate
Time frame: one year or until reoperation
recurrence rate
Time frame: one year or until reoperation
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