Clinical trial · Interventional
Cost-utility Analysis of the Use of a Laser Fiber in the Management of Non-abscessed Pilonidal Cyst
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-abscessed Pilonidal Cyst | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional surgery | Procedure | — | UNRESOLVED |
| Laser fiber treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laser fiber
- description
- 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.
- interventionNames
- Procedure: Laser fiber treatment
- type
- ACTIVE_COMPARATOR
- label
- Conventional surgery
- description
- 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.
- interventionNames
- Procedure: Conventional surgery
Primary outcomes (1)
- measure
- Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available