Pilonidal CystPILOLASNCT05513898
Treatment of Pilonidal Cyst With Holmium Laser
An observational study of Pilonidal Cyst, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Observational study on the treatment of pilonidal cyst with Holmium laser. Single-centre retrospective study of medical data from patients' medical records Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Cyst
- How many people
- 231 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Observational study on the treatment of pilonidal cyst with Holmium laser. Single-centre retrospective study of medical data from patients' medical records
Read the detailed description
From the medical records of a series of patients treated for pilonidal cysts with Holmium laser:
- Primary objective: to assess the rate of healing at 1 month after Holmium laser treatment (healing being defined as no dressing)
- 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
- Conditions
- Pilonidal Cyst
- Medical subject headings
- Pilonidal Sinus
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate
explanatory analysis of the healing rate at Month 1
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Apr 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal CystStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513898
- Sponsor's protocol ID
- COS-RGDS-2020-06-028-
- Acronym
- PILOLAS
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pilonidal Cyst With Holmium Laser
- ClinicalTrials.gov ID
- NCT05513898
- Acronym / sponsor ID
- PILOLAS / COS-RGDS-2020-06-028-
- Conditions
- Pilonidal Cyst
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study on the treatment of pilonidal cyst with Holmium laser. Single-centre retrospective study of medical data from patients' medical records
Detailed description
From the medical records of a series of patients treated for pilonidal cysts with Holmium laser:
- Primary objective: to assess the rate of healing at 1 month after Holmium laser treatment (healing being defined as no dressing)
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Healing rate
Time frame: Month 1
explanatory analysis of the healing rate at Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Cyst, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate (time frame: Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.