Prospective Study in Laser Treatment of Pilonidal Cysts
ConditionPilonidal Sinus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Departemental Vendee
About this trial
The goal of this observational study is to evaluate the recurrence rate after laser treatment of pilonidal sinus within two years of the procedure in adult patients who require this procedure to treat their pilonidal sinus.
The main question it aims to answer is:
• Is there a clinical recurrence (presence of a fistula in the intergluteal cleft) 2 years after laser treatment of pilonidal sinus? Participants who undergo surgery as part of their regular medical care will answer survey questions about recurrence at 1 and 2 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients requiring laser surgery for pilonidal sinus, of any type (including recurrence after radical cure or laser treatment)
Patient able to understand the protocol and having given written informed consent to participate in the study,
Patient affiliated to the social security system or entitled to it.
Disqualifiers
Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
Patient already included in a research study
Patient under guardianship, conservatorship, or deprived of liberty
Patient under an activated future protection mandate
Trial population
The study will be conducted in two centers that regularly perform laser treatment for pilonidal cysts. Recruitment will be conducted prospectively upon the patients' arrival at the digestive surgery department.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
240 Participants
are grouped into 1 trial groupGroup A: Patients requiring laser surgery for pilonidal sinus
Trial outcomes
Primary outcomes
1
Clinical recurrence
2-year recurrence rate after laser sinusectomy (presence of openings in the intergluteal cleft)
Time frame
2 years post-operativelySponsors and contacts
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Source ClinicalTrials.gov