[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642675":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":45,"studyPopulation":16,"armGroups":46,"interventions":59,"overallOfficials":16,"centralContacts":68,"locations":74,"responsibleParty":111,"collaborators":16,"id":113,"slug":16,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":16,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":135,"whyStopped":16,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Elsan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"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 \u002F QALY.","12 months after intervention",[14,18,21,23,25,28,32,36],{"measure":15,"description":16,"timeFrame":17},"Incremental cost-utility ratio at 3 months",null,"3 months after intervention",{"measure":19,"description":16,"timeFrame":20},"Healing duration","Up to 12 months after intervention",{"measure":22,"description":16,"timeFrame":17},"Closure of non-abscessed pilonidal cyst",{"measure":24,"description":16,"timeFrame":12},"Recurrence of non-abscessed pilonidal cyst",{"measure":26,"description":16,"timeFrame":27},"Postoperative complications","Short term: intervention to day 15; medium term: day 15 to month 3; long term: month 6 to month 12",{"measure":29,"description":30,"timeFrame":31},"Treatment parameters","Duration of intervention and occupation time of operating room.","At day 0 intervention",{"measure":33,"description":34,"timeFrame":35},"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.",{"measure":37,"description":38,"timeFrame":20},"Duration of sick leave","Days from hospital discharge after treatment to return to work.",{"allocation":40,"interventionModel":41,"interventionModelDescription":16,"primaryPurpose":42,"observationalModel":16,"timePerspective":16,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":16,"whoMasked":16},"NONE","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.",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Laser fiber","EXPERIMENTAL","Laser fiber introduced through the cyst tract to destroy the cyst walls by thermal effect\u002Fburning; performed under general anesthesia with a small dry dressing afterwards.",[52],"Procedure: Laser fiber treatment",{"label":54,"type":55,"description":56,"interventionNames":57},"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.",[58],"Procedure: Conventional surgery",[60,65],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":16},"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.",[48],{"type":61,"name":54,"description":66,"armGroupLabels":67,"otherNames":16},"Conventional surgical excision of the entire cystic area with packing and absorbent dressing.",[54],[69],{"name":70,"role":71,"phone":72,"phoneExt":16,"email":73},"Charlène Py, Eng","CONTACT","+33556003048","charlene.py@elsan.care",[75,95],{"facility":76,"status":16,"city":77,"state":16,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Clinique Esquirol Saint Hilaire ELSAN","Agen","47000","France","FR",{"type":82,"coordinates":83},"Point",[84,85],0.62055,44.20199,{"lat":85,"lon":84},[88,92],{"name":89,"role":71,"phone":90,"phoneExt":16,"email":91},"Lucie RANDAZZO","+335 53 69 12 53","lucie.randazzo@elsan.care",{"name":93,"role":94,"phone":16,"phoneExt":16,"email":16},"Damien LOUIS, MD","PRINCIPAL_INVESTIGATOR",{"facility":96,"status":16,"city":97,"state":16,"zip":98,"country":79,"countryCode":80,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Polyclinique du Parc - ELSAN","Caen","14000",{"type":82,"coordinates":100},[101,102],-0.35912,49.18585,{"lat":102,"lon":101},[105,109],{"name":106,"role":71,"phone":107,"phoneExt":16,"email":108},"Elise DELARUE","+332-30-32-28-49","elise.delarue@elsan.care",{"name":110,"role":94,"phone":16,"phoneExt":16,"email":16},"Julie LEQUET, MD",{"type":112,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100642675",false,"NCT07652099","Cost-utility Analysis of the Use of a Laser Fiber in the Management of Non-abscessed Pilonidal Cyst","ACONIDAL","Inclusion Criteria:\n\n1. Male or female aged 18 years or older and younger than 80 years.\n2. Patient for whom excision of a non-abscessed pilonidal cyst by laser fiber or conventional surgery is indicated.\n3. Patient informed and having provided free, informed, written consent before any study-specific procedure.\n\nExclusion Criteria:\n\n1. Acute abscess.\n2. Contraindication to surgery and\u002For anesthesia.\n3. Need for urgent intervention for non-abscessed pilonidal cyst.\n4. Participation in another ongoing study or exclusion period.\n5. No health insurance coverage\u002Fprotection.\n6. Legal protection measure or deprived of liberty by judicial or administrative decision.\n7. Hospitalized without consent.","ALL","18 Years","79 Years",{"count":123,"type":124},150,"ESTIMATED","INTERVENTIONAL",[127],"NA","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.",[130],"Non-abscessed Pilonidal Cyst",[132,133,48,54,134],"Pilonidal disease","Pilonidal sinus","Cost-utility","NOT_YET_RECRUITING","2026-06-11",{"date":138,"type":139},"2026-06-16","ACTUAL",{"date":141,"type":124},"2026-06-15",{"date":143,"type":124},"2029-12-15",{"name":5,"class":6},2]