About this trial
This multicenter, prospective, randomized, open-label trial compares laser fiber treatment with conventional surgery in adults with non-abscessed pilonidal cyst. The main objective is to evaluate the incremental cost-utility ratio of laser fiber versus conventional surgery over 12 months from a societal perspective. Secondary objectives include 3-month cost-utility, healing time, closure at 3 months, recurrence at 12 months, postoperative complications, treatment parameters, postoperative pain, and duration of sick leave.
Eligibility criteria
Qualifiers
Male or female aged 18 years or older and younger than 80 years.
Patient for whom excision of a non-abscessed pilonidal cyst by laser fiber or conventional surgery is indicated.
Patient informed and having provided free, informed, written consent before any study-specific procedure.
Disqualifiers
Acute abscess.
Contraindication to surgery and/or anesthesia.
Need for urgent intervention for non-abscessed pilonidal cyst.
Participation in another ongoing study or exclusion period.
Trial design
Treatments tested in this trial
- Laser fiber treatment
- Conventional surgery