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ClinicalTrials.gov ID

NCT07652099

Lead Sponsor

ElsanOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

150Estimated

Last Update Posted

Jun 16, 2026Actual

Start Date

Jun 15, 2026Estimated

Primary Completion Date

Dec 15, 2029Estimated

Completion Date

Dec 15, 2029Estimated

Official Title

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

Brief 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.

Detailed Description

Pilonidal cyst surgery is common in France and mainly affects young adults. Conventional surgery is effective but may be associated with longer healing time, prolonged dressing use, and work absence. Laser fiber treatment is a minimally invasive alternative used in France since 2019 and may reduce healing time and postoperative burden; however, prospective randomized comparative medico-economic evidence is lacking. This national multicenter study randomizes adults with non-abscessed pilonidal cyst to laser fiber treatment or conventional surgery in a 1:1 ratio. The primary endpoint is the incremental cost-utility ratio over 12 months, using total costs and utility derived from EQ-5D-5L (QALY). Participants are followed from baseline to month 12, with assessments at J8, J15, M3, M6, M9, and M12.

• Non-abscessed Pilonidal Cyst

• Laser fiber treatment
• Conventional surgery

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

ElsanOTHER

elise.delarue@elsan.care+332-30-32-28-49