Prospective Study in Laser Treatment of Pilonidal Cysts (LASPRO)

March 20, 2026 updated by: Centre Hospitalier Departemental Vendee

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

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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