Laser treatment with two-year follow-up for pilonidal cysts
Prospective Study on the Incidence of Recurrence in Laser Treatment of Pilonidal Cysts
Centre Hospitalier Departemental Vendee · NCT07314632
This project will see if laser surgery prevents pilonidal sinus recurrence within two years in adults who need the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Departemental Vendee (other) |
| Locations | 2 sites (Cornebarrieu and 1 other locations) |
| Trial ID | NCT07314632 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study of adult patients who undergo laser surgery for pilonidal sinus as part of routine clinical care. Participants will complete follow-up surveys at 1 year and 2 years to record clinical recurrence, defined as presence of a fistula in the intergluteal cleft. Enrollment includes primary and recurrent cases at two French centers, Clinique des Cèdres (Cornebarrieu) and CHD Vendée (La Roche-sur-Yon). The protocol excludes patients enrolled in other interventional research or those under legal protection orders.
Who should consider this trial
Good fit: Adults who require laser surgery for pilonidal sinus (including recurrent disease), can give informed consent, and are affiliated with the social security system are ideal candidates.
Not a fit: People under guardianship or other legal protection, those already in another interventional research protocol, or patients who do not receive laser surgery are unlikely to benefit from this observational follow-up.
Why it matters
Potential benefit: If successful, the results could give patients and surgeons clearer two-year recurrence rates after laser treatment to guide care and expectations.
How similar studies have performed: Previous small observational and randomized studies of minimally invasive laser approaches have reported promising short-term recurrence rates, but long-term comparative evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Patient under family authorization * Patient under judicial protection.
Where this trial is running
Cornebarrieu and 1 other locations
- Clinique des Cèdres — Cornebarrieu, France (RECRUITING)
- CHD Vendée — La Roche-sur-Yon, France (RECRUITING)
Study contacts
- Principal investigator: Tristan GREILSAMER, PH — Centre Hospitalier Departemental Vendée
- Study coordinator: Agnès DORION
- Email: agnes.dorion@ght85.fr
- Phone: 0251446380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pilonidal Sinus, Pilonidal sinus, laser, risk factors, Recurrence rates