Cost-utility Analysis of the Use of a Laser Fiber in the Management of Non-abscessed Pilonidal Cyst
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laser fiber treatment, Conventional surgery.
- Who it may be relevant to
- Registry conditions: Non-abscessed Pilonidal Cyst. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure 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. - Procedure Conventional surgery
Conventional surgical excision of the entire cystic area with packing and absorbent dressing.
Primary outcome measures
- Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery [Time frame: 12 months after intervention]
Secondary outcome measures (8)
- Incremental cost-utility ratio at 3 months [Time frame: 3 months after intervention]
- Healing duration [Time frame: Up to 12 months after intervention]
- Closure of non-abscessed pilonidal cyst [Time frame: 3 months after intervention]
- Recurrence of non-abscessed pilonidal cyst [Time frame: 12 months after intervention]
- Postoperative complications [Time frame: Short term: intervention to day 15; medium term: day 15 to month 3; long term: month 6 to month 12]
- Treatment parameters [Time frame: At day 0 intervention]
- Postoperative pain evolution [Time frame: Baseline to 12 months after intervention Pain measured at J0, J8, J15, M3, M6, M9, M12.]
- Duration of sick leave [Time frame: Up to 12 months after intervention]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- No health insurance coverage/protection.
- Legal protection measure or deprived of liberty by judicial or administrative decision.
- Hospitalized without consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Clinique Esquirol Saint Hilaire ELSAN — Agen
- Polyclinique du Parc - ELSAN — Caen
Identifiers
NCT: NCT07652099 · ACONIDAL