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NCT07652099
Cost-utility Analysis of the Use of a Laser Fiber in the Management of Non-abscessed Pilonidal Cyst
Conditions: Non-abscessed Pilonidal Cyst
Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Elsan
Location: Clinique Esquirol Saint Hilaire ELSAN Agen
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 Criteria
Inclusion Criteria:
1. Male or female aged 18 years or older and younger than 80 years.
2. Patient for whom excision of a non-abscessed pilonidal cyst by laser fiber or conventional surgery is indicated.
3. Patient informed and having provided free, informed, written consent before any study-specific procedure.
Exclusion Criteria:
1. Acute abscess.
2. Contraindication to surgery and/or anesthesia.
3. Need for urgent intervention for non-abscessed pilonidal cyst.
4. Participation in another ongoing study or exclusion period.
5. No health insurance coverage/protection.
6. Legal protection measure or deprived of liberty by judicial or administrative decision.
7. Hospitalized without consent.
Source: ClinicalTrials.gov (NCT07652099). StuddyBuddy aggregates publicly available trial information.