Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease
NCT ID: NCT05569135
Last Updated: 2022-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
121 participants
OBSERVATIONAL
2018-03-01
2022-10-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
Laser ablation
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
Interventions
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Laser ablation
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
Eligibility Criteria
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Inclusion Criteria
* Patients who underwent debridement for pilonidal disease
Exclusion Criteria
* Antibiotic use within 4 weeks before surgery
* Patients lost to follow-up at 3,7 and 30 days; 6, 12 and 36 months
18 Years
ALL
No
Sponsors
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Istanbul Medipol University Hospital
OTHER
Responsible Party
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Principal Investigators
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Naciye Cigdem Arslan, MD
Role: PRINCIPAL_INVESTIGATOR
Medipol University
Locations
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Medipol Bahcelievler Hospital
Istanbul, Other (Non U.s.), Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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E-10840098-772.02-2926
Identifier Type: -
Identifier Source: org_study_id
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