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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorElsan

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

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators