Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease

Pilonidal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05569135
• Other study ID #: E-10840098-772.02-2926
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: October 3, 2022

Study information

• Verified date: October 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pilonidal Disease

Intervention

Device:
• 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

Locations

Country	Name	City	State
Turkey	Medipol Bahcelievler Hospital	Istanbul	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Tezel E. A new classification according to navicular area concept for sacrococcygeal pilonidal disease. Colorectal Dis. 2007 Jul;9(6):575-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease recurrence at 36 months	Any ongoing or recurrent sypmtoms were recorded	36 months
Secondary	Complications after the procedure	Safety of the procedure	1 month
Secondary	Incidence of adverse events	Safety of the procedure	1 month