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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура Conventional surgery
  Conventional surgical excision of the entire cystic area with packing and absorbent dressing.

Первичные конечные точки

• Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery [Срок оценки: 12 months after intervention]

Вторичные конечные точки (8)

• Incremental cost-utility ratio at 3 months [Срок оценки: 3 months after intervention]
• Healing duration [Срок оценки: Up to 12 months after intervention]
• Closure of non-abscessed pilonidal cyst [Срок оценки: 3 months after intervention]
• Recurrence of non-abscessed pilonidal cyst [Срок оценки: 12 months after intervention]
• Postoperative complications [Срок оценки: Short term: intervention to day 15; medium term: day 15 to month 3; long term: month 6 to month 12]
• Treatment parameters [Срок оценки: At day 0 intervention]
• Postoperative pain evolution [Срок оценки: Baseline to 12 months after intervention Pain measured at J0, J8, J15, M3, M6, M9, M12.]
• Duration of sick leave [Срок оценки: Up to 12 months after intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Clinique Esquirol Saint Hilaire ELSAN — Agen
• Polyclinique du Parc - ELSAN — Caen

Идентификаторы

NCT: NCT07652099 · ACONIDAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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