An interventional study of Laser fiber treatment and Conventional surgery in Non-abscessed Pilonidal Cyst, sponsored by Elsan. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Elsan · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Elsan is the lead sponsor of 68 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Time frame: 12 months after intervention
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
Duration of intervention and occupation time of operating room.
Time frame: At day 0 intervention
Postoperative pain evolution
Numeric Rating Scale with analgesic use taken into account.
Time frame: 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.
Time frame: Up to 12 months after intervention
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Dec 2029, 42 months later.
Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 42 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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