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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-abscessed Pilonidal Cyst
• Intervention / Treatment: Procedure: Laser fiber treatment; Procedure: Conventional surgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlène Py, Eng; Phone Number: +33556003048; Email: charlene.py@elsan.care

Study Locations

• France
  • Agen, France, 47000
    • Clinique Esquirol Saint Hilaire ELSAN
    • Contact: Lucie RANDAZZO; Phone Number: +335 53 69 12 53; Email: lucie.randazzo@elsan.care
    • Principal Investigator: Damien LOUIS, MD
  • Caen, France, 14000
    • Polyclinique du Parc - ELSAN
    • Contact: Elise DELARUE; Phone Number: +332-30-32-28-49; Email: elise.delarue@elsan.care
    • Principal Investigator: Julie LEQUET, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Duration of intervention and occupation time of operating room.	At day 0 intervention
Postoperative pain evolution	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	Days from hospital discharge after treatment to return to work.	Up to 12 months after intervention

Collaborators and Investigators

• Sponsor: Elsan

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 15, 2029
• Study Completion (Estimated): December 15, 2029

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cost-utility; Pilonidal disease; Pilonidal sinus; Laser fiber; Conventional surgery
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: ACONIDAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No