Cost-utility Analysis of the Use of a Laser Fiber in the Management of Non-abscessed Pilonidal Cyst
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Laser fiber
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.
干预措施: Laser fiber treatment (Procedure)
Conventional surgery
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.
干预措施: Conventional surgery (Procedure)
结局指标
主要结局
Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery
时间窗: 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.
次要结局
- 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)
- Postoperative pain evolution(Baseline to 12 months after intervention Pain measured at J0, J8, J15, M3, M6, M9, M12.)
- Duration of sick leave(Up to 12 months after intervention)