Laser fiber treatment
ProcedureUse 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.
NCT Number: NCT07652099
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.
Trial opening soon.
Get Notified18 year–79 year
All sexes
Interventional
Not applicable
Clinique Esquirol Saint Hilaire ELSAN, Agen, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 surgical excision of the entire cystic area with packing and absorbent dressing.
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.
Time frame: 3 months after intervention
Time frame: Up to 12 months after intervention
Time frame: 3 months after intervention
Time frame: 12 months after intervention
Time frame: Short term: intervention to day 15; medium term: day 15 to month 3; long term: month 6 to month 12
Time frame: At day 0 intervention
Duration of intervention and occupation time of operating room.
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.
Time frame: Up to 12 months after intervention
Days from hospital discharge after treatment to return to work.
Contact information is provided by the study sponsor or research team.
Elsan
Other
Acronym: ACONIDAL
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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.
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