Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07652099

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Esquirol Saint Hilaire ELSAN, Agen, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Laser fiber treatment

Procedure

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.

conventional surgery

Procedure

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

Primary outcomes

  1. Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery

    Time frame: 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.

Secondary outcomes

  1. Incremental cost-utility ratio at 3 months

    Time frame: 3 months after intervention

  2. Healing duration

    Time frame: Up to 12 months after intervention

  3. Closure of non-abscessed pilonidal cyst

    Time frame: 3 months after intervention

  4. Recurrence of non-abscessed pilonidal cyst

    Time frame: 12 months after intervention

  5. Postoperative complications

    Time frame: Short term: intervention to day 15; medium term: day 15 to month 3; long term: month 6 to month 12

  6. Treatment parameters

    Time frame: At day 0 intervention

    Duration of intervention and occupation time of operating room.

  7. Postoperative pain evolution

    Time frame: 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.

  8. Duration of sick leave

    Time frame: Up to 12 months after intervention

    Days from hospital discharge after treatment to return to work.

Study contacts

Contact information is provided by the study sponsor or research team.

Charlène Py, Eng

CONTACT

[email protected]

+33556003048

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Acronym: ACONIDAL

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.