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Cost-utility Analysis of the Use of a Laser Fiber in the Management of Non-abscessed Pilonidal Cyst (ACONIDAL)

2026年6月11日 更新者：Elsan
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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 法国
      • Agen、法国、47000
        • Clinique Esquirol Saint Hilaire ELSAN
        • 接触：
        • 首席研究员：
          • Damien LOUIS, MD
      • Caen、法国、14000
        • Polyclinique du Parc - ELSAN
        • 接触：
        • 首席研究员：
          • Julie LEQUET, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
程序：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.
有源比较器：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.
程序：Conventional surgery
Conventional surgical excision of the entire cystic area with packing and absorbent dressing.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery
大体时间：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.
12 months after intervention

次要结果测量

结果测量
措施说明
大体时间
Incremental cost-utility ratio at 3 months
大体时间：3 months after intervention
3 months after intervention
Healing duration
大体时间：Up to 12 months after intervention
Up to 12 months after intervention
Closure of non-abscessed pilonidal cyst
大体时间：3 months after intervention
3 months after intervention
Recurrence of non-abscessed pilonidal cyst
大体时间：12 months after intervention
12 months after intervention
Postoperative complications
大体时间：Short term: intervention to day 15; medium term: day 15 to month 3; long term: month 6 to month 12
Short term: intervention to day 15; medium term: day 15 to month 3; long term: month 6 to month 12
Treatment parameters
大体时间：At day 0 intervention
Duration of intervention and occupation time of operating room.
At day 0 intervention
Postoperative pain evolution
大体时间：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.
Baseline to 12 months after intervention Pain measured at J0, J8, J15, M3, M6, M9, M12.
Duration of sick leave
大体时间：Up to 12 months after intervention
Days from hospital discharge after treatment to return to work.
Up to 12 months after intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Elsan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月15日

初级完成 (估计的)

2029年12月15日

研究完成 (估计的)

2029年12月15日

研究注册日期

首次提交

2026年6月11日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ACONIDAL

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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