Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease

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.

Study Overview

• Status: Completed
• Conditions: Pilonidal Disease
• Intervention / Treatment: Device: Laser ablation

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• Turkey
  • Other (Non U.s.)
    • Istanbul, Other (Non U.s.), Turkey, 34196
      • Medipol Bahcelievler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Female and males older than 18 years old

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: Naciye Cigdem Arslan, MD, Medipol University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): October 3, 2019
• Study Completion (Actual): October 3, 2022

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: E-10840098-772.02-2926

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No