Non-abscessed Pilonidal CystACONIDALNCT07652099
Cost-utility Analysis of the Use of a Laser Fiber in the Management of Non-abscessed Pilonidal Cyst
A study testing Laser fiber treatment and Conventional surgery in people with Non-abscessed Pilonidal Cyst, run by Elsan at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Non-abscessed Pilonidal Cyst
- What is being tested?
- Laser fiber treatment and Conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jun 2026to 15 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Clinique Esquirol Saint Hilaire ELSAN
Agen, 47000
Lucie RANDAZZO, +335 53 69 12 53, lucie.randazzo@elsan.care
Damien LOUIS, MD
Polyclinique du Parc - ELSAN
Caen, 14000
Elise DELARUE, +332-30-32-28-49, elise.delarue@elsan.care
Julie LEQUET, MD
About this study
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.
Read the 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.
- Conditions
- Non-abscessed Pilonidal Cyst
- Being tested
- Laser fiber treatment, Conventional surgery
- Keywords
- Pilonidal disease, Pilonidal sinus, Laser fiber, Conventional surgery, Cost-utility
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser fiber treatmentProcedure or surgery
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 surgeryProcedure or surgery
Conventional surgical excision of the entire cystic area with packing and absorbent dressing.
| Study group | Role | What they receive |
|---|---|---|
| Laser fiber | Experimental | 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. Receives: Procedure: Laser fiber treatment |
| Conventional surgery | Active comparator | 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. Receives: Procedure: Conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after intervention
Secondary outcomes (8)
Incremental cost-utility ratio at 3 months
Measured: 3 months after intervention
Healing duration
Measured: Up to 12 months after intervention
Closure of non-abscessed pilonidal cyst
Measured: 3 months after intervention
Recurrence of non-abscessed pilonidal cyst
Measured: 12 months after intervention
Postoperative complications
Measured: 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.
Measured: At day 0 intervention
Postoperative pain evolution
Numeric Rating Scale with analgesic use taken into account.
Measured: 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.
Measured: Up to 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Dec 2029 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-abscessed Pilonidal CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652099
- Sponsor's protocol ID
- ACONIDAL
- Acronym
- ACONIDAL
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Analysis of the Use of a Laser Fiber in the Management of Non-abscessed Pilonidal Cyst
- ClinicalTrials.gov ID
- NCT07652099
- Acronym / sponsor ID
- ACONIDAL / ACONIDAL
- Conditions
- Non-abscessed Pilonidal Cyst
- Keywords
- Pilonidal disease, Pilonidal sinus, Laser fiber, Conventional surgery, Cost-utility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Dec 2029 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser fiber | Experimental | Procedure: Laser fiber treatmentLaser 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. |
| Conventional surgery | Active comparator | Procedure: Conventional surgeryComplete 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser fiber treatmentUse 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. | Procedure or surgery | Laser fiber |
| Conventional surgeryConventional surgical excision of the entire cystic area with packing and absorbent dressing. | Procedure or surgery | Conventional surgery |
Primary outcome
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.
8 secondary outcomes
Incremental cost-utility ratio at 3 months
Time frame: 3 months after intervention
Healing duration
Time frame: Up to 12 months after intervention
Closure of non-abscessed pilonidal cyst
Time frame: 3 months after intervention
Recurrence of non-abscessed pilonidal cyst
Time frame: 12 months after intervention
Postoperative complications
Time frame: Short term: intervention to day 15; medium term: day 15 to month 3; long term: month 6 to month 12
Treatment parameters
Time frame: At day 0 intervention
Postoperative pain evolution
Time frame: Baseline to 12 months after intervention Pain measured at J0, J8, J15, M3, M6, M9, M12.
Duration of sick leave
Time frame: Up to 12 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser fiber treatment and Conventional surgery in people with Non-abscessed Pilonidal Cyst, run by Elsan at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlène Py, Eng (+33556003048, charlene.py@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost-utility ratio (ICUR) of laser fiber versus conventional surgery (time frame: 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.