Non-abscessed Pilonidal Cyst
Conditions
Keywords
Pilonidal disease, Pilonidal sinus, Laser fiber, Conventional surgery, Cost-utility
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.
Interventions
PROCEDURELaser 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.
PROCEDUREConventional surgery
Conventional surgical excision of the entire cystic area with packing and absorbent dressing.
Sponsors
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery | 12 months after intervention | Calculated from total 12-month costs (direct medical, direct non-medical, indirect costs, including recurrences) and utility gain derived from EQ-5D-5L / QALY. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incremental cost-utility ratio at 3 months | 3 months after intervention | — |
| Healing duration | Up to 12 months after intervention | — |
| Closure of non-abscessed pilonidal cyst | 3 months after intervention | — |
| Recurrence of non-abscessed pilonidal cyst | 12 months after intervention | — |
| Postoperative complications | Short term: intervention to day 15; medium term: day 15 to month 3; long term: month 6 to month 12 | — |
| Treatment parameters | At day 0 intervention | Duration of intervention and occupation time of operating room. |
| Postoperative pain evolution | Baseline to 12 months after intervention Pain measured at J0, J8, J15, M3, M6, M9, M12. | Numeric Rating Scale with analgesic use taken into account. |
| Duration of sick leave | Up to 12 months after intervention | Days from hospital discharge after treatment to return to work. |
Countries
France
Contacts
CONTACTCharlène Py, Eng
Outcome results
None listed