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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser fiber | Experimental | Laser fiber introduced through the cyst tract to destroy the cyst walls by thermal effect/burning; performed under general anesthesia with a small dry dressing afterwards. |
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| Conventional surgery | Active Comparator | Complete excision of the cystic area by incision around the entire contour of the cyst, followed by placement of packing and an absorbent dressing; performed under general anesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser fiber treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery | Calculated from total 12-month costs (direct medical, direct non-medical, indirect costs, including recurrences) and utility gain derived from EQ-5D-5L / QALY. | 12 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlène Py, Eng | Contact | +33556003048 | charlene.py@elsan.care |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Esquirol Saint Hilaire ELSAN | Agen | 47000 | France |
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| ID | Term |
|---|---|
| D010864 | Pilonidal Sinus |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
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| Conventional surgery | Procedure | Conventional surgical excision of the entire cystic area with packing and absorbent dressing. |
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| 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 | Duration of intervention and occupation time of operating room. | At day 0 intervention |
| Postoperative pain evolution | Numeric Rating Scale with analgesic use taken into account. | Baseline to 12 months after intervention Pain measured at J0, J8, J15, M3, M6, M9, M12. |
| Duration of sick leave | Days from hospital discharge after treatment to return to work. | Up to 12 months after intervention |
| Polyclinique du Parc - ELSAN | Caen | 14000 | France |
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