Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease

NCT05569135 | Completed FDA Device

• 1 other identifier: E-10840098-772.02-2926
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Disease

Outcome Measures

Primary Outcomes (1)

• disease recurrence at 36 months

  Any ongoing or recurrent sypmtoms were recorded

  36 months

Secondary Outcomes (2)

• Complications after the procedure

  1 month

• Incidence of adverse events

  1 month

Study Arms (2)

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

Interventions

Laser ablation DEVICE

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

Debridiment with laser ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female and males older than 18 years old

You may qualify if:

• Patients with Class III, IV, and V pilonidal disease according to Tezel Navicular Area Classification
• Patients who underwent debridement for pilonidal disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Medipol Bahcelievler Hospital

Istanbul, Other (Non U.s.), 34196, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 17573759 BACKGROUND

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Naciye Cigdem Arslan, MD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: March 1, 2018
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

TU (1)