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

11. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Agen, Frankrig, 47000
        • Clinique Esquirol Saint Hilaire ELSAN
        • Kontakt:
        • Ledende efterforsker:
          • Damien LOUIS, MD
      • Caen, Frankrig, 14000
        • Polyclinique du Parc - ELSAN
        • Kontakt:
        • Ledende efterforsker:
          • Julie LEQUET, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: 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.
Aktiv komparator: 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.
Procedure: Conventional surgery
Conventional surgical excision of the entire cystic area with packing and absorbent dressing.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incremental cost-utility ratio at 3 months
Tidsramme: 3 months after intervention
3 months after intervention
Healing duration
Tidsramme: Up to 12 months after intervention
Up to 12 months after intervention
Closure of non-abscessed pilonidal cyst
Tidsramme: 3 months after intervention
3 months after intervention
Recurrence of non-abscessed pilonidal cyst
Tidsramme: 12 months after intervention
12 months after intervention
Postoperative complications
Tidsramme: 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
Tidsramme: At day 0 intervention
Duration of intervention and occupation time of operating room.
At day 0 intervention
Postoperative pain evolution
Tidsramme: 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
Tidsramme: Up to 12 months after intervention
Days from hospital discharge after treatment to return to work.
Up to 12 months after intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Elsan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

15. december 2029

Studieafslutning (Anslået)

15. december 2029

Datoer for studieregistrering

Først indsendt

11. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACONIDAL

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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