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.
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.
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.
Parallel
Laser fiber treatment
Procedure/SurgeryUse of a laser fiber introduced through the pilonidal cyst tract to destroy the cyst walls. Main steps include tract exploration, curettage, irrigation, two laser passes, and dry dressing.
Conventional surgery
Procedure/SurgeryConventional surgical excision of the entire cystic area with packing and absorbent dressing.
Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery
Calculated from total 12-month costs (direct medical, direct non-medical, indirect costs, including recurrences) and utility gain derived from EQ-5D-5L / QALY.
Incremental cost-utility ratio at 3 months
Healing duration
Closure of non-abscessed pilonidal cyst
Recurrence of non-abscessed pilonidal cyst
This trial is not recruiting at the moment. You can still explore other options:
