Pilonidal DiseaseNCT05569135
Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease
An observational study of Pilonidal Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of laser ablation (LA) in minimally invasive management of pilonidal disease (PD). Data of the patients with PD who were eligible for simple debridement have been prospectively collected since March 2018, when laser ablation treatment came into use in our institution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- Laser ablation
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 3 Oct 2022
- 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
- Adult, Older adult
Study population: Female and males older than 18 years old
Who may be able to join
- Patients with Class III, IV, and V pilonidal disease according to Tezel Navicular Area Classification
- Patients who underwent debridement for pilonidal disease
Who cannot join
- Patients with acute abscess (Tezel Class II)
- Antibiotic use within 4 weeks before surgery
- Patients lost to follow-up at 3,7 and 30 days; 6, 12 and 36 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol Bahcelievler Hospital
Istanbul, Other (Non U.s.), 34196
About this study
Official title: Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease: Retrospective Analysis of Mid-term Outcome
This study aims to investigate the effect of laser ablation (LA) in minimally invasive management of pilonidal disease (PD).
Data of the patients with PD who were eligible for simple debridement have been prospectively collected since March 2018, when laser ablation treatment came into use in our institution. Laser ablation treatment was offered to all eligible patients. All the patients underwent debridement (removal of hair and/or necrotic tissues through pits using a clamp/curette/brush) of PD; LA was added to the procedure in patients who were willing to have LA. The surgical outcome of two procedures was compared. The primary outcome measure was recurrence at 36 months.
- Conditions
- Pilonidal Disease
- Being tested
- Laser ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser ablationDevice
A diode-laser that has been reported to be safe and effective in several treatments including pilonidal disease, anal fistula, hemorrhoids, and vascular ablation was used to obtain shrinkage of pilonidal cyst
| Study group | Role | What they receive |
|---|---|---|
| Debridement only | Debridement of the pilonidal cyst through pits was performed in this group. After the removal of hair and necrotic tissues through pits, the surgical site was covered with a simple gauze dressing for 1 day. Patients were allowed to return to work and sit freely on the day of surgery. | |
| Debridiment with laser ablation | This group underwent the same procedure as the debridement group. After the removal of hair and necrotic tissues through pits, a diode laser at 1470 wavelength was inserted and the pilonidal cavity was ablated in a continuous fashion. The surgical site was covered with a simple gauze dressing for 1 day. Patients were allowed to return to work and sit freely on the day of surgery. Receives: Device: Laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease recurrence at 36 months
Any ongoing or recurrent sypmtoms were recorded
Measured: 36 months
Secondary outcomes (2)
Complications after the procedure
Safety of the procedure
Measured: 1 month
Incidence of adverse events
Safety of the procedure
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Mar 2018
- Primary completion3 Oct 2019
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naciye Cigdem Arslan, MD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569135
- Sponsor's protocol ID
- E-10840098-772.02-2926
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Tezel E. A new classification according to navicular area concept for sacrococcygeal pilonidal disease. Colorectal Dis. 2007 Jul;9(6):575-6. doi: 10.1111/j.1463-1318.2007.01236.x. No abstract available.
PubMed 17573759Arslan NC, Bilgin IA, Gulcu B, Bayraktar B, Eray IC, Bisgin T, Yildirim Y, Aghayeva A, Aydin I, Bilgic C, Boluk S, Kurtul CI, Ramoglu N, Yildirim A, Bayraktar IE, Bayraktar O. Does laser treatment affect outcome in pilonidal sinus disease? Long-term multicenter retrospective analysis of pit-picking alone vs. pit-picking with laser. Tech Coloproctol. 2026 May 13;30(1):103. doi: 10.1007/s10151-026-03314-8.
PubMed 42128975
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease: Retrospective Analysis of Mid-term Outcome
- ClinicalTrials.gov ID
- NCT05569135
- Acronym / sponsor ID
- E-10840098-772.02-2926
- Conditions
- Pilonidal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 6 Oct 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.
This study aims to investigate the effect of laser ablation (LA) in minimally invasive management of pilonidal disease (PD).
Data of the patients with PD who were eligible for simple debridement have been prospectively collected since March 2018, when laser ablation treatment came into use in our institution. Laser ablation treatment was offered to all eligible patients. All the patients underwent debridement (removal of hair and/or necrotic tissues through pits using a clamp/curette/brush) of PD; LA was added to the procedure in patients who were willing to have LA. The surgical outcome of two procedures was compared. The primary outcome measure was recurrence at 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Debridement only | – | –Debridement of the pilonidal cyst through pits was performed in this group. After the removal of hair and necrotic tissues through pits, the surgical site was covered with a simple gauze dressing for 1 day. Patients were allowed to return to work and sit freely on the day of surgery. |
| Debridiment with laser ablation | – | Device: Laser ablationThis group underwent the same procedure as the debridement group. After the removal of hair and necrotic tissues through pits, a diode laser at 1470 wavelength was inserted and the pilonidal cavity was ablated in a continuous fashion. The surgical site was covered with a simple gauze dressing for 1 day. Patients were allowed to return to work and sit freely on the day of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Female and males older than 18 years old
Key inclusion criteria (2 listed)
- Patients with Class III, IV, and V pilonidal disease according to Tezel Navicular Area Classification
- Patients who underwent debridement for pilonidal disease
Key exclusion criteria (3 listed)
- Patients with acute abscess (Tezel Class II)
- Antibiotic use within 4 weeks before surgery
- Patients lost to follow-up at 3,7 and 30 days; 6, 12 and 36 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser ablationA diode-laser that has been reported to be safe and effective in several treatments including pilonidal disease, anal fistula, hemorrhoids, and vascular ablation was used to obtain shrinkage of pilonidal cyst | Device | Debridiment with laser ablation |
Primary outcome
disease recurrence at 36 months
Time frame: 36 months
Any ongoing or recurrent sypmtoms were recorded
2 secondary outcomes
Complications after the procedure
Time frame: 1 month
Incidence of adverse events
Time frame: 1 month
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 6 Oct 2022.
- Background: PubMed 17573759Tezel E. A new classification according to navicular area concept for sacrococcygeal pilonidal disease. Colorectal Dis. 2007 Jul;9(6):575-6. doi: 10.1111/j.1463-1318.2007.01236.x. No abstract available.
- Derived from this study: PubMed 42128975Arslan NC, Bilgin IA, Gulcu B, Bayraktar B, Eray IC, Bisgin T, Yildirim Y, Aghayeva A, Aydin I, Bilgic C, Boluk S, Kurtul CI, Ramoglu N, Yildirim A, Bayraktar IE, Bayraktar O. Does laser treatment affect outcome in pilonidal sinus disease? Long-term multicenter retrospective analysis of pit-picking alone vs. pit-picking with laser. Tech Coloproctol. 2026 May 13;30(1):103. doi: 10.1007/s10151-026-03314-8.
- Individual participant dataSharing planned: Undecided
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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.
Naciye Cigdem Arslan, MD principal investigator
Medipol University
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 Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 6 Oct 2022. 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 Turkey (Türkiye). 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?
disease recurrence at 36 months (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05569135, which also lists 2 linked publications.
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 6 Oct 2022.