Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease

Study Overview
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Brief Summary
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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.

Official Title
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Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease: Retrospective Analysis of Mid-term Outcome

Conditions
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Pilonidal Disease

Intervention / Treatment
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* Device: Laser ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Class III, IV, and V pilonidal disease according to Tezel Navicular Area Classification Patients who underwent debridement for pilonidal disease Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Debridement only<br>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<br>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. | Device: Laser ablation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease recurrence at 36 months | Any ongoing or recurrent sypmtoms were recorded | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications after the procedure | Safety of the procedure | 1 month | 
| Incidence of adverse events | Safety of the procedure | 1 month |