Treatment of Pilonidal Cyst With Holmium Laser (PILOLAS)

Observational study on the treatment of pilonidal cyst with Holmium laser. Single-centre retrospective study of medical data from patients' medical records

Study Overview

• Status: Completed
• Conditions: Pilonidal Cyst

Detailed Description

From the medical records of a series of patients treated for pilonidal cysts with Holmium laser:

1. Primary objective: to assess the rate of healing at 1 month after Holmium laser treatment (healing being defined as no dressing)

2. Secondary objectives: to assess the following:

   • Healing rate at last follow-up (1 month after surgery)
   • Recurrence rate at last follow-up (1 month after surgery)
   • Consumption of >1 level analgesics in the week and month following the procedure
   • Duration of nursing care

• Study Type: Observational
• Enrollment (Actual): 231

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69009
    • Clinique de la Sauvegarde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients participating in the study were operated on at the centre between AUGUST and NOVEMBER 2020. The study is based solely on a review of the medical records of these patients. No further evaluation is planned.

Description

Inclusion Criteria:

• Patient aged 18 years or older, who has been informed of the research;
• Patient with a pilonidal cyst treated with Holmium Laser during a scheduled procedure.

Exclusion Criteria:

• Patient under legal protection, guardianship or curatorship;
• Patient who has indicated his opposition to the use of his data.
• Patient undergoing emergency surgery for an abscess

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing rate	explanatory analysis of the healing rate at Month 1	Month 1

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Cysts; Pilonidal Sinus
• Other Study ID Numbers: COS-RGDS-2020-06-028-

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