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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07652099). StuddyBuddy aggregates publicly available trial information.