Cost-utility Analysis of the Use of a Laser Fiber in the Management of Non-abscessed Pilonidal Cyst

Condition(s) studied

Investigational drug(s) / intervention(s)

Laser fiber treatment: Use 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: Conventional surgical excision of the entire cystic area with packing and absorbent dressing.

Study summary

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

Primary outcome measure(s)

• Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery — 12 months after intervention
  Calculated from total 12-month costs (direct medical, direct non-medical, indirect costs, including recurrences) and utility gain derived from EQ-5D-5L / QALY.

Trial sites (2)

More Elsan trials in France