Prospective Study in Laser Treatment of Pilonidal Cysts

NCT07314632 | Recruiting

• 2 other identifiers: CH25_00982025-A02356-43
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pilonidal Sinus

Keywords

Pilonidal sinus; laser; risk factors; Recurrence rates

Outcome Measures

Primary Outcomes (1)

• Clinical recurrence

  2-year recurrence rate after laser sinusectomy (presence of openings in the intergluteal cleft)

  2 years post-operatively

Study Arms (1)

Patients requiring laser surgery for pilonidal sinus

pilonidal sinus of any type (including recurrence after radical cure or laser treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (2)

Clinique des Cèdres

Cornebarrieu, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Officials

• Tristan GREILSAMER, PH

  Centre Hospitalier Departemental Vendée

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnès DORION

CONTACT

0251446380; agnes.dorion@ght85.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): June 12, 2030
• Study Completion (Estimated): June 12, 2030
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)