Prospective Study in Laser Treatment of Pilonidal Cysts (LASPRO)

Prospective Study on the Incidence of Recurrence in Laser Treatment of Pilonidal Cysts

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.

Study Overview

• Status: Recruiting
• Conditions: Pilonidal Sinus

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Agnès DORION; Phone Number: +33 0251446380; Email: agnes.dorion@ght85.fr

Study Locations

• France
  • Cornebarrieu, France
    • Recruiting
    • Clinique des Cèdres
    • Principal Investigator: Francesco MARTINI, PH
  • La Roche-sur-Yon, France
    • Recruiting
    • CHD Vendée
    • Principal Investigator: Tristan GREILSAMER, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients requiring laser surgery for pilonidal sinus; pilonidal sinus of any type (including recurrence after radical cure or laser treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical recurrence	2-year recurrence rate after laser sinusectomy (presence of openings in the intergluteal cleft)	2 years post-operatively

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Tristan GREILSAMER, PH, Centre Hospitalier Departemental Vendee

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): June 12, 2030
• Study Completion (Estimated): June 12, 2030

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: risk factors; laser; Recurrence rates; Pilonidal sinus
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: CH25_0098; 2025-A02356-43 (Other Identifier: national registration number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No