Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease

Completed

• Conditions: Pilonidal Disease
• Interventions: Device: Laser ablation

• Registration Number: NCT05569135
• Lead Sponsor: Istanbul Medipol University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-10-03
• Status Verified: 2022-10
• Study Completion: 2022-10-03
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-06
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Debridiment with laser ablation	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.

Primary Outcome Measures

Name	Time	Method
disease recurrence at 36 months	36 months	Any ongoing or recurrent sypmtoms were recorded

Secondary Outcome Measures

Name	Time	Method
Complications after the procedure	1 month	Safety of the procedure
Incidence of adverse events	1 month	Safety of the procedure

Trial Locations

Locations (1)

Medipol Bahcelievler Hospital; 🇹🇷 Istanbul, Other (Non U.s.), Turkey